CO M M E M ORA T I N G
25
YEAR S
POSITIVELY AWARE Jan uary+feb ruary 2014
The search for an HIV VACCINE
BARCELONA
AND BEYOND
PLUS
HEPATITIS C TESTING AND TREATMENT TWO HIV researchERS DISCUSS THE ROAD AHEAD Sex and science— PUT A RING ON IT How one Person can maKe a difference— The Story of PA and TPAN
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POSITIVELY AWARE
A Day with HIV Hits the road
Photo: AMber K. Dukes/CDC
A
selection of 16 pictures from A Day with HIV is now on display at the Central Library of the Atlanta-Fulton Public Library System. The pictures represent a cross-section of the more than 170 photos that were taken on September 21, 2013 for A Day with HIV, Positively Aware magazine’s anti-stigma campaign. The library is the first stop of a 2014 nationwide traveling exhibit of the poster-size pictures. It represents another way of extending A Day with HIV beyond the campaign’s website and social media presence. The traveling photo exhibit is a joint effort between the CDC’s Let’s Stop HIV Together campaign and Positively Aware and is designed to raise awareness and educate local communities about HIV, testing, and prevention, and to contribute to changing perceptions surrounding HIV.
The exhibit opened in conjunction with World AIDS Day and is on display until January 4, 2014. The Central Library is located at One Margaret Mitchell Drive in downtown Atlanta. For more information about the exhibit,
go to http://afpls.org/events/eventscalendar. For more information about Let’s Stop HIV Together, visit cdc.gov/ actagainstaids/together. The complete gallery of photo submissions is on view at adaywthhiv.com.
CO M M E M ORA T I N G
25
YEAR S
POSITIVELY AWARE JOURNALISM. INTEGRITY. HOPE.
Jeff Berry editor- in - Chief
Enid Vázquez a s s o c i at e e d i t o r
Sue Saltmarsh copy Editor
proofreader
Joshua Thorne Web Master
Rick Guasco C r e at i v e d i r e c t o r contributing writers
Liz Highleyman Sal Iacopelli Laura Jones Jim Pickett Matt Sharp photogr aphers
Chris Knight Joshua Thorne M e dical advisors
Daniel S. Berger, MD Gary Bucher, MD Michael Cristofano, PA Joel Gallant, MD Swarup Mehta, PharmD adve rtising inq u irie s
Lorraine Hayes l.hayes@tpan.com Subscription services
Shelby Pollard distribution@tpan.com POSITIVELY AWARE IS PUBLISHED BY
5050 N. Broadway St. SUITE 300 Chicago, IL 60640-3016 phone: (773) 989–9400 fax : (773) 989–9494 email : inbox@tpan.com www.positivelyaware.com
4
JA N UA RY + FEB R UA RY 2 014
Creative Director Rick Guasco, Copy editor sue saltmarsh, kevin Rehrer, and editor-in-chief Jeff Berry.
Checking in
W
hen Kevin Rehrer decided to
participate in A Day with HIV and submitted his photo with a pseudonym for his last name, it served as a wake-up call and sparked in him a desire to start his own anti-stigma campaign. Using his own talents and the drive of an Energizer bunny on steroids, he is determined to educate people like his own family, who rejected him upon finding out he was positive. After Kevin told his friend Adam that he was HIV-positive, Adam told his grandmother. She cautioned Adam to stay away from Kevin, not sure if he could “catch it” like the flu from exposure to saliva. When Adam told her she had the wrong information, she said it was better to be safe than sorry. Outside the knowledgeable HIV community lies a whole world of ignorance and fear that fuels the misinformation and stigma, says Kevin, and it’s this world that he’s decided to change. “It’s fear, that’s all it is,” Kevin says, generously forgiving the pain of his family’s judgmental abandonment. “It’s fear and ignorance, and they don’t want to learn.”
Adamant that “there’s always a solution,” Kevin talks about starting a mandatory program providing consistent, factual education about HIV (not sex education) in the public schools, saying that the kids will then end up educating their parents (and grandparents). He talks about creating a network of volunteers to reach out beyond the usual HIV/AIDS “choir.” He understands the value of social media and marketing. And he never gives up. On the day after Thanksgiving, Kevin performed a one-man show in Kansas City in order to inform and raise consciousness about HIV, as well as to raise money to support Positively Aware . The show was streamed live and can now be seen on YouTube (www.youtube.com/ watch?v=kDKleqab0T0). On December 4, Kevin appeared at our office to present Editor Jeff Berry with a check for $200. Kevin will soon be leaving Kansas City behind and going for the bright lights of the Big Apple. Here at PA, we have no doubt that we’ll be hearing more about how he’s made some of those lights brighter. —SUE SALTMARSH
We accept contribution of articles covering medical or personal aspects of HIV/AIDS. We reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may use your actual name or a pseudonym for publication, but please include your name and phone number. Although Positively Aware takes great care to ensure the accuracy of all the information that it presents, Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Aware are not necessarily those of staff or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in Positively Aware do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, preferably a personal physician. A model, photographer, or author’s HIV status should not be assumed based on their appearance in Positively Aware, association with TPAN, or contributions to this journal.
POSITIVELY AWARE
Photo: JOSHUA THORNE
Jason Lancaster
JAN+FEB 2014 VOLUME 26
NUMBER 1
Opening session and reception of the AIDS Vaccine 2013 conference in barcelona, spain.
F e at u r e s
D e p a r tm e n ts
O n li n e
14 Sex and science
6 In Box and
Transplanting HOPE
Patrick Kiser talks intravaginal rings and victory moments.
Readers Poll
by Sue Saltmarsh
HIV organ donation becomes a possibility.
22 Barcelona and beyond
Notes from the AIDS Vaccine 2013 conference.
By Jeff Berry
25 Liver Meeting update
Vaccine results were among the highlights of the annual meeting of the American Association for the Study of Liver Diseases.
Photo: Global HIV Vaccine Enterprise
By Andrew Reynolds
32 Take two pills and call your pharmacist
7 Editor’s Note
Seasons of change.
12 BRIEFLY
New HIV drug. HIV testing for newborns. Virus returns to Boston patients.
by Sue Saltmarsh
positivelyaware.com/ 2013/14_01/transplant.shtml
Houston Buyers Club Desperate times beyond Dallas. by Enid Vázquez
positivelyaware.2013/14_01/ houstonbuyersclub.shtml
41 Wholistic Picture
by Sue saltmarsh
The CDC looks at improving care through pharmacies.
by Enid Vázquez
33 One person can make a difference
How Chris Clason’s vision led to the birth of TPAN and Positively Aware.
by Enid Vázquez
42 Exploring possibilities
Two HIV researchers talk about their work and what lies ahead.
Interview by Jeff Berry
ON THE COVER The 38-story Torre Agbar is the gateway to the high tech district of barcelona. Spain’s second largest city was the setting for the 2013 AIDS Vaccine conference. page 22 POSITIVELY AWARE
JA N UA RY + FEB R UA RY 2 014
5
IN B OX
R e ad er s p oll
administrations—this is a disease that does not discriminate, but touches every dimension of human well-being: mental, physical, spiritual, in relationships, and environmentally. So why not represent every race and gender on the battle lines? —cliffwms44
A Day with HIV Renaissance Man Great article, Sue [see NOV+DEC issue]. You captured [Carlton’s] essence beautifully. And thank you for keeping the red sweat pants alive.
Just reading PA and enjoying your articles on Carlton Wilborn and A Day with HIV. I even see one of my high school crushes pictured. Thanks for all that your team does! —Allan McClendon Boston
—Sandi Cooksey,
In the NOV+DEC issue, we asked
How important are the arts to your quality of life?
former HSDC dancer
Can’t live without
One of my co-workers was reading
Read these I would like to recommend an addi-
tion [to Carrie Foote’s Read These list in the NOV+DEC issue]. Charles Garfield’s Sometimes My Heart Goes Numb: Love and Caregiving in a Time of AIDS gives an accurate picture of the epidemic in 1996 San Francisco. Anyone interested in exploring the history of AIDS should find it helpful. —Kevin D.
your magazine and suggested I take a look if I thought I didn’t know anyone with HIV. Not only was I shocked by the number of children, women, and straight people who were pictured, but my “cheese guy” was there! I’ve never talked to him about HIV, but the next time I buy some of his delicious goat cheese, I’ll be glad to say I saw him in Positively Aware! Thanks for opening our eyes.
Important
Neutral Not Important
—Sarah Bunch
Advocacy and Activism
Eugene, OR
ACT UP [see the SEP+OCT online extra], both then and now, could teach all
YOUR COMMENTS
“I could use more. It would be nice if there were HIV-specific art events or showings.”
of us advocates for social justice and equality of all kinds some valuable lessons! —SPAN
“I can, but would not want to live without them. Art is such a crucial part of what makes us human.”
I would like to see more straight
African American males in the trenches with me standing shoulder to shoulder fighting for the rights of all and not some. I do owe thanks to those pioneers in the epidemic who fought for what I have today. I am truly grateful for those past and present—they really had balls. A reflection of the direction of the epidemic turned pandemic—the same one that has crossed the desks of five presidents’
‘Cheese Guy:’ Bob skinner’s picture for A Day with HIV.
“They’re not only an important part of my quality of life, but they also contribute to my happiness, sanity, and overall mental well being. I think the arts express an important aspect of humanity and an individual’s mental welfare that is often not addressed or even disregarded.” this issue’s poll question
All communications (letters, email, etc.) are treated as letters to the editor unless otherwise instructed. We reserve the right to edit for length, style, or clarity. Let us if know you prefer we not use your name and city. You can also write: Positively Aware 5050 N. Broadway St., Suite 300, Chicago, IL 60640-3016.
Do you benefit from sharing information and experiences with other HIV-positive people? cast your vote at positivelyaware.com
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JA N UA RY + FEB R UA RY 2 014
POSITIVELY AWARE
Ed itor ’ s n ot e
|
Jeff Berry
Seasons of Change
2
Photo: Joshua Thorne
014 marks 25 years of Positively Aware magazine, which is published by Test Positive Aware Network (TPAN), a non-profit AIDS service organization (ASO) in Chicago.
TPAN was the first place I turned to shortly after testing positive for HIV in 1989. It was a scary time for me and many others as we were fighting for our lives but mostly losing the battle. Our brothers and sisters were dying from a disease we knew little about and were unable to successfully treat. The support and comfort I gained from my comrades during those Tuesday night meetings gave me the will and the hope I needed to continue on, and the information and knowledge I gleaned from the pages of Positively Aware magazine were instrumental to my survival during those dark times. Since its first issue, Positively Aware has been a leader in providing up-to-date, accurate, lifesaving information to those around the country, and the world, who need it most. As with TPAN and its services, at PA we never turn anyone away because of their inability to pay for a subscription, but as a not-for-profit, we are grateful for the many donations from our readers, organizations, and individuals which allow us to continue to do the work we do. My motto has always been, the important thing is that we get the information into people’s hands so that they can live happy, healthy, and productive lives. Back in the ’80s and ’90s, Positively Aware was one of many publications produced by ASOs around the country. Today there are only a handful of these publications left as the Internet has come of age and computers and mobile devices are increasingly the way people access their information. Look for exciting new changes over the coming months, both on our website and with mobile technology, as PA increases its digital presence to respond to that demand. Throughout the entire year, we will be looking back at Positively Aware and many of the stories we have covered, while taking stock of where we are now in the epidemic, and looking ahead to what the future may hold. In this issue, you’ll learn about our history through the story of Chris Clason, the founder of both TPAN and Positively Aware, with a beautiful tribute written by associate editor Enid Vázquez. Andrew Reynolds takes stock of where we are now with hepatitis C testing and
treatment, and you’ll read about progress that was reported at the vaccine conference in Spain, and Sue Saltmarsh talks to Dr. Patrick Kiser about his work on intravaginal rings for prevention. In addition to changes in the magazine, there have been some changes at TPAN as well. In October, I stepped up as Interim CEO of TPAN as we moved into our new home in the Uptown neighborhood of Chicago, the community in the city with the highest incidence of HIV/AIDS. Our new office has allowed us to double the number of counseling and meeting rooms we have, increasing our ability to serve and meet the needs of those who access our services. I and many others have worked hard over the years to build upon the magazine’s strengths and increase its national presence as a voice for people with HIV, while providing information and support to those living with and affected by HIV—many of us have dedicated most of our adult lives to this cause. My vision for TPAN is similar, to inform, advocate, and expand its reach on a national level, while continuing locally to provide quality core services to all populations affected by HIV. Change is inevitable, and as the epidemic and the world has changed, we too must change or risk becoming obsolete and ineffectual. I have been extremely lucky and am forever grateful to have been given the opportunity through my work to make a difference in people’s lives. Whatever I was asked to give of myself, I have received back a thousand times over through the letters, comments, and words of those whose lives I’ve touched. Wherever this journey may take you, remember that I’m there with you, as are many others. You are never alone, you only need to reach out for support and help, and you’ll find it. Sometimes it’s hard to just take that first step. I was so filled with fear that it was incredibly hard for me to go to that first support group at TPAN, but it was probably the best choice I ever made. Now it’s time to make your choice. What will it be?
For two and a half decades POSITIVELY AWARE has been a leader in providing up-to-date, accurate, lifesaving, and life-changing information. Follow Jeff: @PAEDITOR
Take care of yourself and each other.
POSITIVELY AWARE
JA N UA RY + FEB R UA RY 2 014
7
The
one
for me
Patient model. Pill shown is not actual size.
What is COMPLERA? COMPLERA is a prescription HIV medicine that is used as a complete regimen to treat HIV-1 in adults who have never taken HIV medicines before and who have an amount of HIV in their blood (this is called “viral load”) that is no more than 100,000 copies/mL. COMPLERA contains 3 medicines – rilpivirine, emtricitabine and tenofovir disoproxil fumarate. It is not known if COMPLERA is safe and effective in children under the age of 18 years. ®
COMPLERA® does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses you must keep taking COMPLERA. Avoid doing things that can spread HIV-1 to others: always practice safer sex and use condoms to lower the chance of sexual contact with body fluids; never reuse or share needles or other items that have body fluids on them, do not share personal items that may contain bodily fluids. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others.
IMPORTANT SAFETY INFORMATION What is the most important information you should know about COMPLERA? COMPLERA® can cause serious side effects: • Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual (not normal) muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold, especially in your arms and legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat. • Serious liver problems. The liver may become large (hepatomegaly) and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain. • You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking COMPLERA for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions. • Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking COMPLERA, your hepatitis may suddenly get worse. Do not stop taking COMPLERA without first talking to your healthcare provider, as they will need to monitor your health. COMPLERA is not approved for the treatment of HBV.
Who should not take COMPLERA? Do not take COMPLERA if you have ever taken other anti-HIV medicines. COMPLERA may change the effect of other medicines and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses. Do not take COMPLERA if you also take these medicines: • anti-seizure medicines: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol); oxcarbazepine (Trileptal), phenobarbital (Luminal), phenytoin (Dilantin, Dilantin-125, Phenytek) • anti-tuberculosis medicines: rifabutin (Mycobutin), rifampin (Rifater, Rifamate, Rimactane, Rifadin) and rifapentine (Priftin) • proton pump inhibitors for stomach or intestinal problems: esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), dexlansoprazole (Dexilant), omeprazole (Prilosec), pantoprazole sodium (Protonix), rabeprazole (Aciphex) • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate • St. John’s wort (Hypericum perforatum) If you are taking COMPLERA you should not take other HIV medicines or other medicines containing tenofovir (Viread, Truvada, Stribild or Atripla); other medicines containing emtricitabine or lamivudine (Emtriva, Combivir, Epivir, Epivir-HBV, Epzicom, Trizivir, Atripla, Stribild or Truvada); rilpivirine (Edurant) or adefovir (Hepsera). In addition, tell your healthcare provider if you are taking the following medications because they may interfere with how COMPLERA works and may cause side effects: • certain antacid medicines containing aluminum, magnesium hydroxide, or calcium carbonate (examples: Rolaids, TUMS). These medicines must be taken at least 2 hours before or 4 hours after COMPLERA. • medicines to block stomach acid including cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or ranitidine HCL (Zantac). These medicines must be taken at least 12 hours before or 4 hours after COMPLERA. • any of these medicines: clarithromycin (Biaxin); erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Ilosone), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral) methadone (Dolophine); posaconazole (Noxafil), telithromycin (Ketek) or voriconazole (Vfend). • medicines that are eliminated by the kidneys like acyclovir (Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV, Vitrasert), valacyclovir (Valtrex) and valganciclovir (Valcyte).
COMPLERA.
A complete HIV treatment in only 1 pill a day. COMPLERA is for adults who have never taken HIV-1 medicines before and have no more than 100,000 copies/mL of virus in their blood.
Ask your healthcare provider if it’s the one for you.
These are not all the medicines that may cause problems if you take COMPLERA. Tell your healthcare provider about all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.
The most common side effects reported with COMPLERA are trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, rash, tiredness, and depression. Some side effects also reported include vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles) and pain.
Before taking COMPLERA, tell your healthcare provider if you: liver problems, including hepatitis B or C virus infection, or have abnormal liver tests • Have kidney problems • Have ever had a mental health problem • Have bone problems • Are pregnant or planning to become pregnant. It is not known if COMPLERA can harm your unborn child • Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV through their milk to the baby. Also, COMPLERA may pass through breast milk and could cause harm to the baby
This is not a complete list of side effects. Tell your healthcare provider or pharmacist if you notice any side effects while taking COMPLERA, and call your healthcare provider for medical advice about side effects.
• Have
COMPLERA can cause additional serious side effects: • New or worsening kidney problems, including kidney failure. If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider may need to do regular blood tests. • Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, have thoughts of hurting yourself (suicide) or have tried to hurt yourself. • Changes in liver enzymes: People who have had hepatitis B or C, or who have had changes in their liver function tests in the past may have an increased risk for liver problems while taking COMPLERA. Some people without prior liver disease may also be at risk. Your healthcare provider may need to check your liver enzymes before and during treatment with COMPLERA. • Bone problems can happen in some people who take COMPLERA. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones. • Changes in body fat can happen in people taking HIV medicine. • Changes in your immune system. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting COMPLERA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. Additional Information about taking COMPLERA:
• Always take COMPLERA exactly as your healthcare provider tells you to take it.
• Take COMPLERA with food. Taking COMPLERA with food is important to help get the
right amount of medicine in your body. (A protein drink does not replace food. If your healthcare provider stops COMPLERA, make certain you understand how to take your new medicine and whether you need to take your new medicine with a meal.)
Stay under the care of your healthcare provider during treatment with COMPLERA and see your healthcare provider regularly. Please see Brief Summary of full Prescribing Information with important warnings on the following pages.
Learn more at www.COMPLERA.com
BriefBrief Summary Summary of full of Prescribing full Prescribing Information Information
• Worsening Worsening of Hepatitis of Hepatitis B infection. B infection. If youIf have you have hepatitis hepatitis B virus B virus (HBV)(HBV) infection infection and and taketake COMPLERA, COMPLERA, your your HBV HBV may may get worse get worse (flare-up) (flare-up) if youif stop you stop COMPLERA COMPLERA (kom-PLEH-rah) (kom-PLEH-rah) taking taking COMPLERA. COMPLERA. A “flare-up” A “flare-up” is when is when your your HBV HBV infection infection suddenly suddenly returns returns (emtricitabine, (emtricitabine, rilpivirine, rilpivirine, tenofovir tenofovir disoproxil disoproxil fumarate) fumarate) tablets tablets in a in worse a worse way way thanthan before. before. COMPLERA COMPLERA is notis approved not approved for the for treatment the treatment of of BriefBrief summary summary of full of Prescribing full Prescribing Information. Information. For more For more information, information, please please see see HBV,HBV, so you so must you must discuss discuss your your HBV HBV withwith your your healthcare healthcare provider. provider. the full the Prescribing full Prescribing Information Information including including Patient Patient Information. Information. – Do–not Do let notyour let your COMPLERA COMPLERA run out. run out. RefillRefi your ll your prescription prescription or talk or talk to your to your healthcare healthcare provider provider before before your your COMPLERA COMPLERA is allisgone. all gone. WhatWhat is COMPLERA? is COMPLERA? – Do–not Do stop not stop taking taking COMPLERA COMPLERA without without first fitalking rst talking to your to your healthcare healthcare • COMPLERA • COMPLERA is a prescription is a prescription HIV (Human HIV (Human Immunodefi Immunodefi ciency ciency Virus) Virus) medicine medicine provider. provider. that that is used is used to treat to treat HIV-1HIV-1 in adults in adults – If you – If stop you stop taking taking COMPLERA, COMPLERA, your your healthcare healthcare provider provider will need will need to check to check – who – who havehave never never takentaken HIV medicines HIV medicines before, before, and and your your health health oftenoften and and do blood do blood teststests regularly regularly to check to check your your HBV HBV infection. infection. – who – who havehave an amount an amount of HIV of in HIVtheir in their bloodblood (this(this is called is called ‘viral‘viral load’)load’) that that Tell your Tell your healthcare healthcare provider provider aboutabout any new any new or unusual or unusual symptoms symptoms you may you may is noismore no more thanthan 100,000 100,000 copies/mL. copies/mL. YourYour healthcare healthcare provider provider will measure will measure havehave afterafter you stop you stop taking taking COMPLERA. COMPLERA. your your viralviral load.load. WhoWho should should not take not take COMPLERA? COMPLERA? (HIV (HIV is theis virus the virus that that causes causes AIDSAIDS (Acquired (Acquired Immunodefi Immunodefi ciency ciency Syndrome)). Syndrome)). Do not Do take not take COMPLERA COMPLERA if: if: • COMPLERA • COMPLERA contains contains 3 medicines 3 medicines – rilpivirine, – rilpivirine, emtricitabine, emtricitabine, tenofovir tenofovir • your • your HIV infection HIV infection has been has been previously previously treated treated withwith HIV medicines. HIV medicines. disoproxil disoproxil fumarate fumarate – combined – combined in one in tablet. one tablet. It is Ita complete is a complete regimen regimen to to • • you are you taking are taking any of any the of following the following medicines: medicines: treattreat HIV-1HIV-1 infection infection and and should should not be notused be used withwith otherother HIV medicines. HIV medicines. – anti-seizure – anti-seizure medicines: medicines: carbamazepine carbamazepine (Carbatrol, (Carbatrol, Equetro, Equetro, Tegretol, Tegretol, • It is • It notis known not known if COMPLERA if COMPLERA is safe is safe and and effective effective in children in children underunder the age the age Tegretol-XR, Tegretol-XR, Teril,Teril, Epitol); Epitol); oxcarbazepine oxcarbazepine (Trileptal); (Trileptal); phenobarbital phenobarbital of 18ofyears 18 years old. old. (Luminal); (Luminal); phenytoin phenytoin (Dilantin, (Dilantin, Dilantin-125, Dilantin-125, Phenytek) Phenytek) • COMPLERA • COMPLERA doesdoes not cure not cure HIV infection HIV infection or AIDS. or AIDS. You must You must stay stay on continuous on continuous – – anti-tuberculosis anti-tuberculosis (anti-TB) (anti-TB) medicines: medicines: rifabutin rifabutin (Mycobutin); (Mycobutin); rifampin rifampin therapy therapy to control to control HIV infection HIV infection and and decrease decrease HIV-related HIV-related illnesses. illnesses. (Rifater, (Rifater, Rifamate, Rifamate, Rimactane, Rimactane, Rifadin); Rifadin); rifapentine rifapentine (Priftin) (Priftin) • Ask• your Ask your healthcare healthcare provider provider if youif have you have any questions any questions about about how how to to – proton pumppump inhibitor inhibitor (PPI)(PPI) medicine medicine for certain for certain stomach stomach or intestinal or intestinal prevent prevent passing passing HIV to HIVother to other people. people. Do not Do share not share or re-use or re-use needles needles or other or other – proton problems: problems: esomeprazole esomeprazole (Nexium, (Nexium, Vimovo); Vimovo); lansoprazole lansoprazole (Prevacid); (Prevacid); injection injection equipment, equipment, and and do not do share not share personal personal itemsitems that that can have can have bloodblood or or dexlansoprazole (Dexilant); (Dexilant); omeprazole omeprazole (Prilosec, (Prilosec, Zegerid); Zegerid); pantoprazole pantoprazole bodybody fluidsfluids on them, on them, like toothbrushes like toothbrushes and and razorrazor blades. blades. Always Always practice practice safersafer dexlansoprazole sodium sodium (Protonix); (Protonix); rabeprazole rabeprazole (Aciphex) (Aciphex) sex by sexusing by using a latex a latex or polyurethane or polyurethane condom condom to lower to lower the chance the chance of sexual of sexual contact contact withwith semen, semen, vaginal vaginal fluidsfluids or blood. or blood. – more – more thanthan 1 dose 1 dose of theof steroid the steroid medicine medicine dexamethasone dexamethasone or dexamethasone or dexamethasone sodium sodium phosphate phosphate WhatWhat is theis most the most important important information information I should I should knowknow about about COMPLERA? COMPLERA? – St.–John’s St. John’s wortwort (Hypericum (Hypericum perforatum) perforatum) COMPLERA COMPLERA can can cause cause serious serious sideside effects, effects, including: including: • If you • If take you take COMPLERA, COMPLERA, you should you should not take: not take: • Build-up • Build-up of anofacid an acid in your in your bloodblood (lactic (lactic acidosis). acidosis). Lactic Lactic acidosis acidosis can can happen happen in some in some people people who who taketake COMPLERA COMPLERA or similar or similar (nucleoside (nucleoside analogs) analogs) – Other – Other medicines medicines that that contain contain tenofovir tenofovir (Atripla, (Atripla, Stribild, Stribild, Truvada, Truvada, Viread) Viread) medicines. medicines. Lactic Lactic acidosis acidosis is a serious is a serious medical medical emergency emergency that that can lead can lead to to – Other – Other medicines medicines that that contain contain emtricitabine emtricitabine or lamivudine or lamivudine (Combivir, (Combivir, death. death. Lactic Lactic acidosis acidosis can be canhard be hard to identify to identify early,early, because because the symptoms the symptoms Emtriva, Emtriva, EpivirEpivir or Epivir-HBV, or Epivir-HBV, Epzicom, Epzicom, Trizivir, Trizivir, Atripla, Atripla, Truvada, Truvada, Stribild) Stribild) couldcould seemseem like symptoms like symptoms of other of other health health problems. problems. 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COMPLERA? – have – have unusual unusual (not (not normal) normal) muscle muscle painpain Before Before you take you take COMPLERA, COMPLERA, tell your tell your healthcare healthcare provider provider if you: if you: – have – have trouble trouble breathing breathing • have • have or had or had liverliver problems, problems, including including hepatitis hepatitis B or BC or virus C virus infection, infection, kidney kidney problems, mental mental health health problem problem or bone or bone problems problems – have – have stomach stomach painpain withwith nausea nausea (feeling (feeling sick sick to your to your stomach) stomach) or vomiting or vomiting problems, • are• pregnant are pregnant or plan or plan to become to become pregnant. pregnant. It is Itnotis known not known if COMPLERA if COMPLERA can can – feel– cold, feel cold, especially especially in your in your armsarms and and legs legs harmharm your your unborn unborn child.child. – feel– dizzy feel dizzy or lightheaded or lightheaded Pregnancy Pregnancy Registry. Registry. ThereThere is a pregnancy is a pregnancy registry registry for women for women who who taketake – have – have a fast a fast or irregular or irregular heartbeat heartbeat antiviral antiviral medicines medicines during during pregnancy. pregnancy. The purpose The purpose of this of this registry registry is toiscollect to collect information aboutabout the health the health of you of and you and your your baby.baby. Talk Talk to your to your healthcare healthcare • Severe • Severe liverliver problems. problems. Severe Severe liverliver problems problems can happen can happen in people in people who who taketake information provider provider aboutabout how how you can you take can take part part in this in this registry. registry. COMPLERA. COMPLERA. In some In some cases, cases, thesethese liverliver problems problems can lead can lead to death. to death. YourYour liverliver may may become become largelarge (hepatomegaly) (hepatomegaly) and and you may you may develop develop fat infatyour in your liverliver • are• breast-feeding are breast-feeding or plan or plan to breast-feed. to breast-feed. You You should should not breastfeed not breastfeed if youif you (steatosis). (steatosis). Call Call youryour healthcare healthcare provider provider rightright awayaway if youif get you any get of anythe of the havehave HIV because HIV because of the of risk the risk of passing of passing HIV to HIVyour to your baby.baby. Do not Do breastfeed not breastfeed following following symptoms symptoms of liver of liver problems: problems: if youif are you taking are taking COMPLERA. COMPLERA. At least At least two of twotheof medicines the medicines contained contained in in COMPLERA COMPLERA can be canpassed be passed to your to your babybaby in your in your breast breast milk.milk. We do Wenot do know not know – your – your skin skin or theor white the white part part of your of your eyeseyes turnsturns yellow yellow (jaundice) (jaundice) whether whether this this couldcould harmharm your your baby.baby. Talk Talk to your to your healthcare healthcare provider provider aboutabout the the – dark – dark “tea-colored” “tea-colored” urineurine bestbest way way to feed to feed your your baby.baby. – light-colored – light-colored bowelbowel movements movements (stools) (stools) Tell your Tell your healthcare healthcare provider provider about about all the all medicines the medicines you take, you take, including including ®
– loss – loss of appetite of appetite for several for several daysdays or longer or longer
prescription prescription and and nonprescription nonprescription medicines, medicines, vitamins, vitamins, and and herbal herbal supplements. supplements.
– nausea – nausea
•
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•
®
You• You maymay be more be more likelylikely to get to lactic get lactic acidosis acidosis or severe or severe liverliver problems problems if if you are you female, are female, veryvery overweight overweight (obese), (obese), or have or have beenbeen taking taking COMPLERA COMPLERA for afor long a long time.time.
• COMPLERA COMPLERA maymay affect affect the way the way otherother medicines medicines work,work, and and otherother medicines medicines maymay affect affect how how COMPLERA COMPLERA works, works, and and maymay cause cause serious serious sideside effects. effects. If If you take you take certain certain medicines medicines withwith COMPLERA, COMPLERA, the amount the amount of COMPLERA of COMPLERA in your in your bodybody may may be too below too and low and it may it may not work not work to help to help control control your your HIV infection. HIV infection. The HIV The virus HIV virus in your in your bodybody may may become become resistant resistant to COMPLERA to COMPLERA or other or other HIV HIV medicines medicines that that are like are it. like it.
The most The most common common side side effects effects of COMPLERA of COMPLERA include: include: Especially Especially tell your tell your healthcare healthcare provider provider if youif take: you take: an •antacid an antacid medicine medicine that that contains contains aluminum, aluminum, magnesium magnesium hydroxide, hydroxide, or or • trouble • trouble sleeping sleeping (insomnia) (insomnia) calcium calcium carbonate. carbonate. If youIf take you take an antacid an antacid during during treatment treatment withwith COMPLERA, COMPLERA, • abnormal • abnormal dreams dreams taketake the antacid the antacid at least at least 2 hours 2 hours before before or atorleast at least 4 hours 4 hours afterafter you you taketake COMPLERA. COMPLERA. • headache • headache • a medicine • a medicine to block to block the acid the acid in your in your stomach, stomach, including including cimetidine cimetidine • dizziness • dizziness (Tagamet), (Tagamet), famotidine famotidine (Pepcid), (Pepcid), nizatidine nizatidine (Axid), (Axid), or ranitidine or ranitidine hydrochloride hydrochloride • diarrhea • diarrhea (Zantac). (Zantac). If youIf take you take one of onethese of these medicines medicines during during treatment treatment withwith • nausea COMPLERA, COMPLERA, taketake the acid the acid blocker blocker at least at least 12 hours 12 hours before before or atorleast at least 4 hours 4 hours • nausea afterafter you take you take COMPLERA. COMPLERA. • rash • rash •
•
any• of anythese of these medicines medicines (if taken (if taken by mouth by mouth or injection): or injection):
•
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• tiredness tiredness
•
• depression depression
– erythromycin – erythromycin (E-Mycin, (E-Mycin, Eryc,Eryc, Ery-Tab, Ery-Tab, PCE,PCE, Pediazole, Pediazole, Ilosone) Ilosone)
•
• vomiting vomiting
– itraconazole – itraconazole (Sporanox) (Sporanox)
•
• stomach stomach painpain or discomfort or discomfort
– ketoconazole – ketoconazole (Nizoral) (Nizoral)
•
skin• skin discoloration discoloration (small (small spotsspots or freckles) or freckles)
•
• pain pain
– methadone – methadone (Dolophine) (Dolophine) – posaconazole – posaconazole (Noxafi (Noxafi l) l) – telithromycin – telithromycin (Ketek) (Ketek) – voriconazole – voriconazole (Vfend) (Vfend) •
Additional Additional common common side side effects effects include: include:
– fluconazole – fluconazole (Diflucan) (Diflucan)
Tell your Tell your healthcare healthcare provider provider if youif have you have any side any side effecteffect that that bothers bothers you or youthat or that doesdoes not go notaway. go away. TheseThese are not are all notthe all possible the possible side side effects effects of COMPLERA. of COMPLERA. For more For more information, information, ask your ask your healthcare healthcare provider provider or pharmacist. or pharmacist.
• medicines medicines that that are eliminated are eliminated by the by kidney, the kidney, including including acyclovir acyclovir (Zovirax), (Zovirax), your your doctor doctor for medical for medical advice advice aboutabout side side effects. effects. You may You may report report side side cidofovir cidofovir (Vistide), (Vistide), ganciclovir ganciclovir (Cytovene (Cytovene IV, Vitrasert), IV, Vitrasert), valacyclovir valacyclovir (Valtrex), (Valtrex), Call Call effects effects to FDA to FDA at 1-800-FDA-1088 at 1-800-FDA-1088 (1-800-332-1088). (1-800-332-1088). and and valganciclovir valganciclovir (Valcyte) (Valcyte)
WhatWhat are the are possible the possible sideside effects effects of COMPLERA? of COMPLERA? COMPLERA COMPLERA can can cause cause serious serious sideside effects, effects, including: including: • See • See “What “What is theis most the most important important information information I should I should knowknow about about COMPLERA?” COMPLERA?” •
• New New or worse or worse kidney kidney problems, problems, including including kidney kidney failure, failure, can happen can happen in in somesome people people who who taketake COMPLERA. COMPLERA. YourYour healthcare healthcare provider provider should should do blood do blood teststests to check to check your your kidneys kidneys before before starting starting treatment treatment withwith COMPLERA. COMPLERA. If youIf you havehave had had kidney kidney problems problems in thein past the past or need or need to take to take another another medicine medicine that that can cause can cause kidney kidney problems, problems, your your healthcare healthcare provider provider may may needneed to dotoblood do blood teststests to check to check your your kidneys kidneys during during your your treatment treatment withwith COMPLERA. COMPLERA.
•
• Depression Depression or mood or mood changes. changes. Tell your Tell your healthcare healthcare provider provider rightright awayaway if if you have you have any of anythe of following the following symptoms: symptoms:
– feeling – feeling sad or sadhopeless or hopeless
HowHow should should I take I take COMPLERA? COMPLERA? •
• Stay Stay under under the care the care of your of your healthcare healthcare provider provider during during treatment treatment withwith COMPLERA. COMPLERA.
•
• Take Take COMPLERA COMPLERA exactly exactly as your as your healthcare healthcare provider provider tellstells you to youtake to take it. it.
•
• Always Always taketake COMPLERA COMPLERA withwith food.food. Taking Taking COMPLERA COMPLERA withwith foodfood is important is important to help to help get the get right the right amount amount of medicine of medicine in your in your body.body. A protein A protein drinkdrink is notis not a substitute a substitute for food. for food. If your If your healthcare healthcare provider provider decides decides to stop to stop COMPLERA COMPLERA and and you are you switched are switched to new to new medicines medicines to treat to treat HIV that HIV that includes includes rilpivirine rilpivirine tablets, tablets, the rilpivirine the rilpivirine tablets tablets should should be taken be taken only only withwith a meal. a meal.
•
Do •not Do change not change your your dosedose or stop or stop taking taking COMPLERA COMPLERA without without first fitalking rst talking withwith your your healthcare healthcare provider. provider. See your See your healthcare healthcare provider provider regularly regularly whilewhile taking taking COMPLERA. COMPLERA.
•
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•
Do •not Do take not take moremore thanthan your your prescribed prescribed dosedose to make to make up for upafor missed a missed dose.dose.
– feeling – feeling anxious anxious or restless or restless – have – have thoughts thoughts of hurting of hurting yourself yourself (suicide) (suicide) or have or have triedtried to hurt to hurt yourself yourself •
• Change Change in liver in liver enzymes. enzymes. People People withwith a history a history of hepatitis of hepatitis B or BC or virus C virus infection infection or who or who havehave certain certain liverliver enzyme enzyme changes changes may may havehave an increased an increased risk risk of developing of developing new new or worsening or worsening liverliver problems problems during during treatment treatment withwith COMPLERA. COMPLERA. LiverLiver problems problems can can also also happen happen during during treatment treatment withwith COMPLERA COMPLERA in people in people without without a history a history of liver of liver disease. disease. YourYour healthcare healthcare provider provider may may needneed to dototests do tests to check to check your your liverliver enzymes enzymes before before and and during during treatment treatment withwith COMPLERA. COMPLERA.
This This BriefBrief Summary Summary summarizes summarizes the most the most important important information information aboutabout COMPLERA. COMPLERA. If youIf would you would like more like more information, information, talk talk withwith your your healthcare healthcare provider. provider. You can You also can also ask your ask your healthcare healthcare provider provider or pharmacist or pharmacist for for information information aboutabout COMPLERA COMPLERA that that is written is written for health for health professionals, professionals, or call or call 1-800-445-3235 1-800-445-3235 or goortogowww.COMPLERA.com to www.COMPLERA.com
•
• Bone Bone problems problems can happen can happen in some in some people people who who taketake COMPLERA. COMPLERA. BoneBone Issued: Issued: JuneJune 20132013 problems problems include include bonebone pain,pain, softening softening or thinning or thinning (which (which may may leadlead to to fractures). fractures). YourYour healthcare healthcare provider provider may may needneed to dotoadditional do additional teststests to check to check your your bones. bones.
•
• Changes Changes in body in body fat can fat happen can happen in people in people taking taking HIV medicine. HIV medicine. TheseThese changes changes may may include include increased increased amount amount of fatofinfatthein upper the upper backback and and neckneck (“buffalo (“buffalo hump”), hump”), breast, breast, and and around around the main the main part part of your of your bodybody (trunk). (trunk). LossLoss of fatoffrom fat from the legs, the legs, armsarms and and faceface may may also also happen. happen. The cause The cause and and longlong termterm health health effecteffect of these of these conditions conditions are not are known. not known.
•
• Changes Changes in your in your immune immune system system (Immune (Immune Reconstitution Reconstitution Syndrome) Syndrome) can can happen happen whenwhen you start you start taking taking HIV medicines. HIV medicines. YourYour immune immune system system may may get get stronger stronger and and beginbegin to fight to fiinfections ght infections that that havehave beenbeen hidden hidden in your in your bodybody for for a long a long time.time. Tell your Tell your healthcare healthcare provider provider if youif start you start having having new new symptoms symptoms afterafter starting starting your your HIV medicine. HIV medicine.
COMPLERA, the COMPLERA Logo, EMTRIVA, GILEAD, the GILEAD Logo, GSI, HEPSERA, STRIBILD, TRUVADA, VIREAD, and VISTIDE are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks referenced herein are the property of their respective owners. ©2013 Gilead Sciences, Inc. All rights reserved. CPAC0056 09/13
Briefly New HIV drug filing for “572-Trii” ViiV Healthcare applied on October 22 for Food and Drug Administration (FDA) approval of its once-daily single tablet regimen known as “572-Trii” (or “Trii” for short, pronounced “try”), which contains the company’s recently approved Tivicay (August 2013), as well as Epzicom (itself a combination of Ziagen and Epivir). Tivicay is a second-generation medication from the integrase inhibitor class of HIV drugs, for which there has been growing enthusiasm since the success of Isentress, the first medication in the class. U.S. treatment guidelines in October added Tivicay plus Epzicom or Truvada to the list of preferred drug regimens for people on first-time therapy. Go to positivelyaware.com/trii.
U.S. HIV treatment guidelines updated New HIV treatment guidelines from the Department of Health and Human Services (DHHS), updated on October 30, now state that all treatments with the class of drugs called integrase strand transfer inhibitors (INSTIs) meet the standard for a “preferred” regimen in people taking antiviral therapy for the first time. Previously, the first INSTI on the market, Isentress, was the preferred drug from this class for first-time therapy. Now, Tivicay, an INSTI approved last August, and elvitegravir, currently available only in the single tablet regimen Stribild, are also considered preferred drugs. Tivicay is expected to also become available in a single tablet regimen (see “572-Trii” above). All three INSTIs have been shown to be non-inferior to preferred regimens in the guidelines. Tivicay is a second-generation INSTI that is effective for people whose therapy with Isentress or elvitegravir has failed, but it needs to be taken twice a day by those individuals, at twice the cost. Isentress, however, has proven 12
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long-term safety and efficacy. Of note, the guidelines state that Tivicay can be taken with either Truvada or with Epzicom, making this the re-appearance of Epzicom on the preferred drug list. (See lead Briefly item for news of a Tivicay/Epzicom combo.) See other considerations in the guidelines at aidsinfo.gov. Also go to PA’s annual HIV drug guide (positivelyaware. com/drugguide) for more information on these medications.
FDA approves new hep C drugs Olysio and Sovaldi Last October, an FDA advisory committee recommended the approval of sofosbuvir and simeprevir (TMC435) for treatment of hepatitis C infection. Simeprevir was approved a month later, with the brand name Olysio. It is the third hep C protease inhibitor on the market, after Incivek and Victrelis. Once-daily Sovaldi (sofosbuvir) was approved on December 6 in combination with ribavirin as an interferon-free treatment for genotype 2 and 3 infection, and in combination with ribavirin and pegylated interferon for genotypes 1 and 4 infection for people taking hepatitis C treatment for the first time. Olysio consists of a once-daily 150 mg capsule administered with pegylated interferon and ribavirin for the treatment of hepatitis C genotypes 1 (the most difficult to treat) and 4 in adults with compensated liver disease (the early stage of disease when the liver is still quite functional), including all stages of fibrosis (hardening of the liver that occurs with disease). The committee looked at simeprevir data from clinical studies in both treatment-naïve people (taking hep C medication for the first time) and those who have failed previous interferon-based therapy.
Updated HIVMA guidelines The HIV Medicine Association (HIVMA) of the Infectious Diseases Society of America
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(IDSA) has updated its HIV care guidelines to reflect the fact that people with HIV are now living normal life spans and their physicians need to focus on preventive care. Reflecting changes in HIV care, the guidelines note that people whose virus levels are undetectable (below 50 copies per mL) should have their viral load measured every six to 12 months, rather than every three to four months as previously recommended. There are also new recommendations for screening for high cholesterol and triglycerides, diabetes, osteoporosis, and colon cancer. See the guidelines in the January edition of Clinical Infectious Diseases or go to idsociety.org.
Virus returns in Boston patients Hopes of HIV eradication were dashed for two men known as the Boston patients when their virus reappeared late last year after going off treatment [see SEP+OCT issue]. Following in the steps of the Berlin patient, Timothy Brown, who remains HIVfree after more than six years, the Boston men had lymphoma that was treated with a bone marrow transplant. No return of their HIV was seen for more than two years in one of the men and more than four years in the second. The men went back on HIV therapy when the virus was detected.
PrEP brochure from CDC The Centers for Disease Control and Prevention (CDC) has issued a new easyto-read brochure on the use of PrEP (pre-exposure prophylaxis, or a preventative therapy taken before a potential HIV exposure). There is only one medication approved for HIV prevention at this time, Truvada (which also treats HIV infection itself). “Are you HIV negative but worried you might become positive?” asks the brochure. “Take charge. Talk to your doctor about PrEP.” It lists questions to
Photo: JOSHUA THORNE
Enid Vázquez
3.3 million
The number of children around the world with HIV under the age of 15, according to UNAIDS. UNAIDS Executive Director Michele Sidibe called for improving testing kits to earlier diagnose infants and for reducing the cost of testing, currently in the $25–50 range.
ask providers about PrEP and resources for more information, including guidelines from the CDC. Go to cdc.gov/hiv/pdf/
risk_PrEP_TalkingtoDr_FINALcleared. pdf. Also go to tpan.com/prep, as well as myprepexperience.blogspot.com.
HOPE Act passes Congress The House of Representatives passed the HIV Organ Policy Equity (HOPE) Act on November 12, which will improve and increase research on donation of organs from deceased HIV-positive donors to HIVpositive recipients, hopefully leading to policy changes in the availability and distribution of organs for transplant. The legislation, supported by both Democrats and Republicans, has passed in both the House and the Senate and was sent to President Obama for his signature. In a press statement, HIV Medical Association (HIVMA) Chair Joel Gallant, MD, MPH, FIDSA, said, “As HIV clinicians and researchers, we applaud Congressional passage of the Act and look forward to its swift enactment after it is signed by the President.” “For patients living with HIV, deceased donors with the same infection represent a unique source of organs. Passage of the HOPE Act will save the lives of hundreds of HIV-infected patients struggling with liver and kidney failure each year. Until enactment of the HOPE Act, research necessary to explore the feasibility of such transplants was banned under federal law.”
Photo: JShawn Thew/EPA
Closing the book on UK’s HIV Treatment Update The print version of the outstanding HIV Treatment Update has ceased to be. The National AIDS Map (NAM) from the United Kingdom published its final issue in November. HTU will continue to be available online, along with the organization’s top-notch conference reporting and news feed. Editor Gus Cairns reported, “We wish it wasn’t so; but the drastic cuts to
voluntary sector HIV funding that have been happening in the last two years, and which have affected NAM as they have other charities, mean we simply can’t afford the cost of a printed newsletter any more—not if it’s at the expense of our core mission to provide information and analysis in the most comprehensive way possible.”
NASTAD announces no ADAP waiting lists On November 25, the National Alliance of State & Territorial AIDS Directors (NASTAD) announced that for the first time since January 2008, there were no waiting lists under the AIDS Drug Assistance Programs (ADAPs). The elimination of ADAP waiting lists was made possible in part due to ADAPs receiving $75 million in Emergency Relief Funds (ERF) which were distributed to states that demonstrated financial need as a result of waiting lists or other
cost-containment measures. In addition, continued supplemental rebates, discounts, and price freezes on drugs that have been negotiated between the ADAP Crisis Task Force and pharmaceutical companies allowed ADAPs to maintain stable budgets.
Body Counts Sean Strub was diagnosed HIV-positive in 1985, after which he overcame his own life-threatening illness, joined ACT UP/ New York, navigated insider politics, founded POZ magazine, and is fighting to end the criminalization of HIV. Body Counts, available January 14, is his compelling record of a remarkable life in the history of the AIDS epidemic.
HIV cure research gets $100M boost On December 2, The Hill reported that $100 million would be “reprioritized” from other AIDS research efforts into those aimed at curing HIV. A new initiative at the National Institutes of Health (NIH) will be aimed at “research toward an HIV cure,” President Obama said at a World AIDS Day event on December 1. Obama also stated that the United States would “remain the global leader in the fight against HIV and AIDS” until the virus is eradicated. The United States is committed to giving as much as $5 billion to the Global Fund to Fight AIDS, Tuberculosis, and Malaria over the next two years, matching every $2 raised from other sources with $1 of government giving. The $100 million in funding over the next three years for the HIV Cure Initiative may seem like a relatively small amount, but some experts have said that as little as $100 million can make significant progress on HIV and AIDS research. Seeing that the NIH has been hard hit by sequester cuts and was flat-funded even before that, this funding could indeed be a shot in the arm to the institution. —SUE SALTMARSH
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13
Sex and Science Patrick Kiser ‘puts a ring on it’ By Sue Saltmarsh
“I
didn’t start out as an HIV researcher—I became one over the last
10 years because I saw that there wasn’t anybody with my skills working in this space,” says the serious scientist who may be known among his peers as “the vagina guy.”
Patrick Kiser, PhD, associate professor of biomedical engineering at Northwestern University, is a leader in the groundbreaking research, design, and development of an intravaginal ring that prevents HIV transmission by delivering the anti-HIV drug tenofovir (brand name Viread) to 14
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the tissues of the vagina. “You can find lots of people who understand material science and how to deliver drugs to the body, but very few people are working in this reproductive space, space that includes sexuality. I think there aren’t a lot of people working in it because it’s kind
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of, well, embarrassing. I’m just fascinated by the pharmacology, the physiology, the behavioral aspects—this ring is going to be involved in someone’s sex life—it’s a really interesting mix of virology, drug delivery, behavior, and biomaterials science.”
Failure and triumph
T
his is a man who’s totally
jazzed by science. But this kind of work is not an exercise in instant gratification. Years of his life, and those of the students working with him, go by
Ring leader: Patrick Kiser holds a prototype of the ring that prevents pregnancy and HIV.
Photo: Ryan Stevenson Teller
before a “touchdown moment” occurs. What about his “end zone victory dance” when a breakthrough has been made or a new benchmark reached? “There are multiple touchdown points,” he replies. “Science is serial failure, lots of setbacks, lots of issues that will impede your progress if you stay on the same path that you’re on. The failure points are a sign that you need to find some other technology, go back to the basic science and try to figure out what’s wrong mechanistically and then try to interfere with the mechanism.
“In pharmaceutical development, one of the key failures is that what you make isn’t scalable, so we get very excited when something doesn’t fail in that way.” One of his biggest victories was a study being published in Proceedings of the National Academy of Sciences that found that the ring was 100% effective in macaques, a definite win for a scientist in the “publish or perish” world of academia. It was also the result of an “intense collaborative effort” with the primate researchers at the CDC, Albert Einstein College of Medicine, colleagues, and students, a project that had been going on for five years, with approximately 25 people involved along the way. Another victory was the FDA’s approval of the ring’s Investigational New Drug (IND) application, which gives it the green light to go into clinical trials. And it wasn’t his victory alone. ‘“Hey, Ryan!” he calls to the student working at a desk outside his office. “You ever make a product before? You ever get something into an IND?” “Nope!” Ryan responds. When asked if he was excited by those achievements, you could almost hear the grin in his voice when he replies, “Yeah!” “It was huge for him!” Kiser proclaims. “It was a huge high five moment! Getting the paper published, getting accepted by our peers, our competitors, and folks who are out there in the wider world of HIV prevention research—those were the folks who were reviewing the paper. Then to have our IND approved. And Ryan had successful tech transfer—taking the technology that we built in our lab in Utah, those ideas and processes, and writing them up in a series of documents that are very detailed, like recipes, and then sending those recipes and sending Ryan and getting the equipment and the people trained in another facility to actually run those processes proved that what we did here is reproducible in their lab. To then get them to make the devices and show they perform equivalent to what we’ve done here is a huge ‘football game.’” Listening to the enthusiasm in his voice, it was easy to imagine what it will be like on the “Super Bowl” day that the ring receives FDA approval.
Nerdy kid
K
iser says he was a nerdy
kid, but credits his parents’ encouragement of his interest in science as a major factor in where he is today. “I had a chemistry set as a kid, they got me a microscope, so I’d go out in the back yard and get samples from the pond and look at amoebas and things and watch them under the microscope. Jacques Cousteau and Spock [the Vulcan, not the baby doctor] and Carl Sagan were my heroes as a boy.” Kiser also values the mentors he’s had along the way. His high school chemistry teacher was one—he took junior-level chemistry as a freshman and then went to college early. Of course, much of his “required knowledge” comes from experience, as well. “They don’t train you in the vagaries of filing and communicating with the FDA, raising money, or training students who come in with just a dream and a goal of becoming a scientist, but aren’t one yet, and somehow you have to get them to create these real things in training them to be scientists,” he says. “All the wonderful relationships, the supportive, mentoring relationships I have with all my collaborators, mentoring from my department and colleagues. Science is like a community, a network of communities, that supports an investigator. So there are all these people who’ve learned to do science with me, whether they’re students or post-docs or technicians or even undergraduates who are out there in industry using techniques they learned while doing science with me and that’s the kind of thing, the warm relationships I have with the people I work with, that motivate me.” Dr. Kiser is adjusting to life in Chicago after living and working in Utah since 2006. He decided to move here because he wanted to get into a “richer, broader, more vibrant community of folks who are working in infectious diseases and especially HIV.” He is also an associate professor in the OB/GYN department of Northwestern’s Feinberg Medical School, where he says “all kinds of amazing things are going on.” “If Utah was a desert, Chicago seems like a jungle,” he says, seeing the city’s “jungle” as “an environment that’s rich,
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‘What this ring is trying to do is a pretty amazing thing—it’s trying to stop a single virus from getting through into a person’s immune system.’ diverse, with all kinds of communities, and all kinds of life. That’s what it feels like to me—tremendously invigorating.” Not surprisingly, a man who spends his days immersed in pharmacology, polymers, and bioengineering probably isn’t going to spend his off time watching Big Brother. Kiser enjoys martial arts, aikido in particular. “It’s a good workout, it’s incredibly challenging, and it has a spiritual side to it too, which is cool,” he says, proving that he himself is as multifaceted as his work. He admits, though, that his passion for research makes his work fun. “I don’t like deadlines so much,” he says wryly, “but working with students, making these devices, running the experiments, getting papers published—all of that is fun to me!” And he does have a cappuccino machine in his office too.
The Ring
S
o how did he get from “Hey!
How about a ring that a woman can manage herself, made out of some sort of polymer, loaded up with an anti-HIV drug that would release the right dose in the right amount of time to prevent HIV transmission?” to actually being able to hold such a ring in his hand with the probability of it soon being FDA approved and marketed being a reachable goal? “When I started, there were no examples of topical antiretrovirals preventing transmission even in the animal models,” Kiser says. “So it wasn’t really clear that by putting a drug topically into the vagina you could stop the transmission of the virus. Even today, we still don’t understand completely how transmission occurs.” Existing data support the theory that infection results from the cells in the epithelium of either the vagina or the rectum interacting with the virus, which replicates, forming a “founder population” from a single virus. “What this ring is trying to do is a pretty amazing thing—it’s trying to stop a single 16
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virus from getting through into a person’s systemic immune system,” he adds. The technology for intravaginal rings was invented in the late 1960s for the delivery of hormones. Over the years, of course, technology has evolved and changed. “One of the major things that we’ve done is to bring in a whole new class of materials that haven’t been looked at before and are much more effective at getting antiviral drugs out and into the tissue in a controlled way to get the right concentration for the right amount of time,” Kiser explains. “The question is that given that I can’t change the drug, what material do I need that will allow me to control how that drug is delivered? We’re putting the materials and the drug together to accomplish a certain set of goals. Coming up with new ways of doing that to achieve our goals more efficiently, more cost-effectively, in a more user-friendly, acceptable way— we’re interested in all those dimensions to optimize these systems to get them to perform well.” Speaking of practical matters, Kiser explained how women would actually use the ring. A rather thick circle of creamy white, it can be inserted by pinching it, which he says results in it “rolling around a bit,” or by forming a figure 8 that unfolds once it’s inside. Unlike the precise placement needed with a diaphragm, the ring can sit anywhere in the vagina and still be effective. To remove it, the woman just hooks it with a finger and pulls it out. It’s washable and can be stored in its packaging, though the hope is that women will not remove them during the 30 days that they’re effective, especially before having sex. Kiser also asserts that men won’t necessarily feel it. He points to the contraceptive Nuvaring, on the market for almost a decade and popular with consumers. According to Nuvaring’s website, in clinical trials, 90 percent of users—both male and female—reported either not feeling the ring or not considering it a problem.
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Patrick KISER: Biomedical engineering is a
The next big thing
R
etrieving another ring
from his desk, Dr. Kiser explained the next project he’s working on—a ring that delivers both tenofovir and a contraceptive. Though it’s not as far along as the HIV-only ring, they had a “touchdown moment” in proving its stability recently and they’ve written a paper that’s under review right now. After that, another IND application will be submitted with hopefully another approval granted. His excitement was obvious. “This is really the most sophisticated intravaginal ring ever made,” he stated confidently. “It’s got one part that’s the tenofovir segment, one that’s the contraceptive segment, and these (pointing to two small bumps at the joins of the two segments) are end caps we put on to constrain the diffusion of the contraceptive—the contraceptive releases 10 micrograms a day and the tenofovir releases 10 milligrams per day. So it’s about 1,000 times different in terms of the amount of drug released.” Obviously, such a ring could change
Photo: SUE SALTMARSH
discipline that’s focused on mitigating human suffering.
the landscape of both HIV and unwanted pregnancies, especially in underdeveloped countries where high rates of poverty, HIV infection, and lack of resources converge to minimize quality of life and life expectancy. But will women use either of them? After disappointing results from past studies, questions remain, but Kiser points out that study design may be a major factor in whether or not women participate and use the products as directed. He notes the voluminous consent forms provided to study participants, mostly in wording the participants need translated, participants not clearly understanding the instructions for using the study medications the right way, and other factors that may interfere in getting reliable data.
The lab
A
walk down a flight of
stairs leads to the lab where all the equipment from his lab in Utah has been shipped (at exorbitant cost, but not as much as it would cost to replace the equipment). A few boxes still lean up against the
wall in the hallway. You can’t help but be struck by how much machinery is in a relatively small space with countertops and cabinets and yet, how well organized it seems to be. It looks a little like the set of Fringe (though without the cow). Inscrutable, shiny metal machines make tubes out of the polymer mixture poured into them and the tubes become the rings when another machine fuses the ends together to form a circle. The concept of coming up with the ideas for these machines in the first place is a bit overwhelming. How do people think of these things? Evidently, that’s what engineering is for. It’s easy to see that Kiser is proud of this lab and rightly so. He explains what each machine does so clearly that you can almost imagine what it must be like to see them in action—well, for the unscientific mind, anyway. And it’s a little awe-inspiring to imagine an actual factory floor filled with copies of these machines, robotically spitting out thousands, millions, of these amazing devices that could save lives all over the world.
Sweet dreams
I
f an actor dreams of winning
an Oscar, a journalist a Pulitzer Prize, a politician a presidential election, what does a scientist dream of? Well, there is a Nobel Prize for science and the money that goes with it. And it might be a thrill being included in the company of Pasteur, Einstein, Salk, Sagan, and Hawking, among others. Maybe Patrick Kiser dreams of the day when HIV is minor enough to be a Wikipedia page rather than a worldwide epidemic. Maybe he dreams of knowing in that HIV-free time that he had a lot to do with it. Or maybe he dreams of the next problem to be solved, the next miraculous device, the next bright-eyed, full-of-hope student that walks into his lab and years later wins his or her own Nobel Prize. “Biomedical engineering is a discipline that’s focused on mitigating human suffering, just like medicine, but we do it from the engineering side.” We can only hope he keeps on doing it.
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What is STRIBILD? STRIBILD is a prescription medicine used to treat HIV-1 in adults who have never taken HIV-1 medicines before. It combines 4 medicines into 1 pill to be taken once a day with food. STRIBILD is a complete single-tablet regimen and should not be used with other HIV-1 medicines. STRIBILD does not cure HIV-1 infection or AIDS. To control HIV-1 infection and decrease HIV-related illnesses you must keep taking STRIBILD. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.
IMPORTANT SAFETY INFORMATION What is the most important information I should know about STRIBILD? STRIBILD can cause serious side effects: • Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual (not normal) muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold especially in your arms and legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat. • Serious liver problems. The liver may become large (hepatomegaly) and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain. • You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking STRIBILD for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
• Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking STRIBILD, your hepatitis may suddenly get worse. Do not stop taking STRIBILD without first talking to your healthcare provider, as they will need to monitor your health. STRIBILD is not approved for the treatment of HBV. Who should not take STRIBILD? Do not take STRIBILD if you: • Take a medicine that contains: alfuzosin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, sildenafil when used for lung problems (Revatio®), triazolam, oral midazolam, rifampin or the herb St. John’s wort. • For a list of brand names for these medicines, please see the Brief Summary on the following pages. • Take any other medicines to treat HIV-1 infection, or the medicine adefovir (Hepsera®). What are the other possible side effects of STRIBILD? Serious side effects of STRIBILD may also include: • New or worse kidney problems, including kidney failure. Your healthcare provider should do regular blood and urine tests to check your kidneys before and during treatment with STRIBILD. If you develop kidney problems, your healthcare provider may tell you to stop taking STRIBILD. • Bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones. • Changes in body fat can happen in people taking HIV-1 medicines. • Changes in your immune system. Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking STRIBILD. The most common side effects of STRIBILD include nausea and diarrhea. Tell your healthcare provider if you have any side effects that bother you or don’t go away.
What should I tell my healthcare provider before taking STRIBILD? • All your health problems. Be sure to tell your healthcare provider if you have or had any kidney, bone, or liver problems, including hepatitis virus infection. • All the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start any new medicines while taking STRIBILD without first talking with your healthcare provider. • If you take hormone-based birth control (pills, patches, rings, shots, etc). • If you take antacids. Take antacids at least 2 hours before or after you take STRIBILD. • If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk. Also, some medicines in STRIBILD can pass into breast milk, and it is not known if this can harm the baby. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see Brief Summary of full Prescribing Information with important warnings on the following pages.
STRIBILD is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV-1 medicines before. STRIBILD does not cure HIV-1 or AIDS.
I started my personal revolution Talk to your healthcare provider about starting treatment. STRIBILD is a complete HIV-1 treatment in 1 pill, once a day.
Ask if it’s right for you.
Patient Information STRIBILDTM (STRY-bild) (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) tablets Brief summary of full Prescribing Information. For more information, please see the full Prescribing Information, including Patient Information. What is STRIBILD? • STRIBILD is a prescription medicine used to treat HIV-1 in adults who have never taken HIV-1 medicines before. STRIBILD is a complete regimen and should not be used with other HIV-1 medicines. • STRIBILD does not cure HIV-1 or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses. • Ask your healthcare provider about how to prevent passing HIV-1 to others. Do not share or reuse needles, injection equipment, or personal items that can have blood or body fluids on them. Do not have sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. What is the most important information I should know about STRIBILD? STRIBILD can cause serious side effects, including: 1. Build-up of lactic acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take STRIBILD or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis: • feel very weak or tired • have unusual (not normal) muscle pain • have trouble breathing • have stomach pain with nausea or vomiting • feel cold, especially in your arms and legs • feel dizzy or lightheaded • have a fast or irregular heartbeat 2. Severe liver problems. Severe liver problems can happen in people who take STRIBILD. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following symptoms of liver problems: • your skin or the white part of your eyes turns yellow (jaundice) • dark “tea-colored” urine • light-colored bowel movements (stools) • loss of appetite for several days or longer • nausea • stomach pain You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking STRIBILD for a long time. 3. Worsening of Hepatitis B infection. If you have hepatitis B virus (HBV) infection and take STRIBILD, your HBV may get worse (flare-up) if you stop taking STRIBILD. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. • Do not run out of STRIBILD. Refill your prescription or talk to your healthcare provider before your STRIBILD is all gone
• Do not stop taking STRIBILD without first talking to your healthcare provider • If you stop taking STRIBILD, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking STRIBILD Who should not take STRIBILD? Do not take STRIBILD if you also take a medicine that contains: • adefovir (Hepsera®) • alfuzosin hydrochloride (Uroxatral®) • cisapride (Propulsid®, Propulsid Quicksolv®) • ergot-containing medicines, including: dihydroergotamine mesylate (D.H.E. 45®, Migranal®), ergotamine tartrate (Cafergot®, Migergot®, Ergostat®, Medihaler Ergotamine®, Wigraine®, Wigrettes®), and methylergonovine maleate (Ergotrate®, Methergine®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • oral midazolam • pimozide (Orap®) • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) • sildenafil (Revatio®), when used for treating lung problems • simvastatin (Simcor®, Vytorin®, Zocor®) • triazolam (Halcion®) • the herb St. John’s wort Do not take STRIBILD if you also take any other HIV-1 medicines, including: • Other medicines that contain tenofovir (Atripla®, Complera®, Viread®, Truvada®) • Other medicines that contain emtricitabine, lamivudine, or ritonavir (Combivir®, Emtriva®, Epivir® or Epivir-HBV®, Epzicom®, Kaletra®, Norvir®, Trizivir®) STRIBILD is not for use in people who are less than 18 years old. What are the possible side effects of STRIBILD? STRIBILD may cause the following serious side effects: • See “What is the most important information I should know about STRIBILD?” • New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking STRIBILD. Your healthcare provider may tell you to stop taking STRIBILD if you develop new or worse kidney problems. • Bone problems can happen in some people who take STRIBILD. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones. • Changes in body fat can happen in people who take HIV-1 medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms and face may also happen. The exact cause and long-term health effects of these conditions are not known. • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.
The most common side effects of STRIBILD include: • Nausea • Diarrhea Tell your healthcare provider if you have any side effect that bothers you or that does not go away. • These are not all the possible side effects of STRIBILD. For more information, ask your healthcare provider. • Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. What should I tell my healthcare provider before taking STRIBILD? Tell your healthcare provider about all your medical conditions, including: • If you have or had any kidney, bone, or liver problems, including hepatitis B infection • If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD. – There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry. • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed if you take STRIBILD. - You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. - Two of the medicines in STRIBILD can pass to your baby in your breast milk. It is not known if the other medicines in STRIBILD can pass into your breast milk. - Talk with your healthcare provider about the best way to feed your baby. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements: • STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works. • Be sure to tell your healthcare provider if you take any of the following medicines: - Hormone-based birth control (pills, patches, rings, shots, etc) - Antacid medicines that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or after you take STRIBILD - Medicines to treat depression, organ transplant rejection, or high blood pressure - amiodarone (Cordarone®, Pacerone®) - atorvastatin (Lipitor®, Caduet®) - bepridil hydrochloric (Vascor®, Bepadin®) - bosentan (Tracleer®) - buspirone - carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegreto®) - clarithromycin (Biaxin®, Prevpac®) - clonazepam (Klonopin®) - clorazepate (Gen-xene®, Tranxene®) - colchicine (Colcrys®) - medicines that contain dexamethasone - diazepam (Valium®)
- digoxin (Lanoxin®) - disopyramide (Norpace®) - estazolam - ethosuximide (Zarontin®) - flecainide (Tambocor®) - flurazepam - fluticasone (Flovent®, Flonase®, Flovent® Diskus, Flovent® HFA, Veramyst®) - itraconazole (Sporanox®) - ketoconazole (Nizoral®) - lidocaine (Xylocaine®) - mexiletine - oxcarbazepine (Trileptal®) - perphenazine - phenobarbital (Luminal®) - phenytoin (Dilantin®, Phenytek®) - propafenone (Rythmol®) - quinidine (Neudexta®) - rifabutin (Mycobutin®) - rifapentine (Priftin®) - risperidone (Risperdal®, Risperdal Consta®) - salmeterol (Serevent®) or salmeterol when taken in combination with fluticasone (Advair Diskus®, Advair HFA®) - sildenafil (Viagra®), tadalafil (Cialis®) or vardenafil (Levitra®, Staxyn®), for the treatment of erectile dysfunction (ED). If you get dizzy or faint (low blood pressure), have vision changes or have an erection that last longer than 4 hours, call your healthcare provider or get medical help right away. - tadalafil (Adcirca®), for the treatment of pulmonary arterial hypertension - telithromycin (Ketek®) - thioridazine - voriconazole (Vfend®) - warfarin (Coumadin®, Jantoven®) - zolpidem (Ambien®, Edlular®, Intermezzo®, Zolpimist®) Know the medicines you take. Keep a list of all your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Do not start any new medicines while you are taking STRIBILD without first talking with your healthcare provider. Keep STRIBILD and all medicines out of reach of children. This Brief Summary summarizes the most important information about STRIBILD. If you would like more information, talk with your healthcare provider. You can also ask your healthcare provider or pharmacist for information about STRIBILD that is written for health professionals, or call 1-800-445-3235 or go to www.STRIBILD.com. Issued: August 2012
COMPLERA, EMTRIVA, GILEAD, the GILEAD Logo, GSI, HEPSERA, STRIBILD, the STRIBILD Logo, TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other marks referenced herein are the property of their respective owners. © 2013 Gilead Sciences, Inc. All rights reserved. QC15554 01/13
CONFERENCE UPDATE AIDS VACCINE 2013
Barcelona and beyond
I
By Jeff Berry
The goal of the conference is to translate science to stakeholders, policy makers, and trial participants and incorporate their perspectives back into the science, according to Bill Snow, Director of the Global HIV Vaccine Enterprise. Due to the U.S. government shutdown in October, the National Institutes of Health (NIH) were unable to send any representatives to attend the conference, causing many last minute changes in the conference proceedings. During a taped opening address National Institute of Allergy & Infectious Diseases (NIAID) director Anthony Fauci emphasized that an HIV vaccine is essential to controlling and ending the HIV pandemic, and that there is a need to combine non-vaccine and vaccine prevention modalities.
Pre-conference Fellows workshop This year, as in years past, nearly two dozen journalists, including this author, were awarded fellowships to attend the conference and a two-day pre-conference workshop. During the Journalist Fellowship Workshop, attendees learned about immune system basics, how 22
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vaccines work, major behavioral and biomedical advances, the latest HIV prevention research, and the research agenda going forward. Vaccines are hard to make, expensive, and take a lot of time to develop. In the last 30 years, there have been only four HIV vaccine trials that have advanced to studies in humans—three of those were stopped or unable to show efficacy, with only one study, the landmark RV144 clinical trial of over 16,000 people in Thailand, showing only a modest protective effect of around 31% (the group that received the vaccine had a 31% lower chance of becoming infected with HIV than those who received the placebo). The window will soon close on placebo-controlled trials, however, as PrEP, microbicides, and other prevention methods become available and more widely used and included as part of any study. Jerry Sadoff, MD, head of research at Johnson & Johnson, has helped make 11 vaccines during his lifetime that have inoculated millions of people, but he has also had spectacular failures. During a workshop session on how vaccines work, he explained how scientists develop
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vaccines by discovering a surrogate or correlate of protection (something that, if you have it, will protect you when you encounter a pathogen, which is any agent that can cause disease, such as a bacteria or virus). Once that surrogate is known, you can make a vaccine that induces the surrogate in animals, and then later in humans, where efficacy endpoints in a study then validate the surrogate. Sadoff likens what happens when we are naturally infected to a race between the immune system and the pathogen. Whichever wins that race lives on, and whichever loses, dies. Or the pathogen lives in us (such as shingles) or moves on (the common cold).
The basics A vaccine typically works by mimicking the pathogen it is trying to protect against. In other words, you are teaching the immune system to respond in a certain way. A vaccine can be administered by injecting into a muscle or administered mucosally, such as using a nasal spray. The body then develops antibodies so that when your body is exposed to that pathogen, it is protected. There are basically three different kinds of HIV vaccines being explored— preventative vaccines to prevent infection; a curative vaccine that would clear the virus very early after infection; and vaccines to keep or control the virus at a very low level (therapeutic). These vaccines do not contain HIV and have no chance of causing infection. A virus such as HIV cannot reproduce on its own, and needs a host cell to reproduce.
Photo: Thinkstockphotos
n October, more than 900 leading vaccine researchers, funders, and policy makers from around the world gathered in Barcelona, Spain for four days for AIDS Vaccine 2013. This is the last year for the AIDS Vaccine conference, which is organized by the Global HIV Vaccine Enterprise, a collaboration of scientific and advocacy HIV vaccine organizations. Starting in 2014, it will expand to include research on prevention, PrEP, and microbicides, as well as vaccines, and will become the HIV Research for Prevention Conference, with the inaugural conference being held in October 2014 in Cape Town, South Africa.
beyond The body’s immune system produces an antibody which binds to the virus to prevent it from entering the cell. All HIVpositive people have antibodies capable of binding to HIV, but only a subset, called neutralizing antibodies, can block the virus from entering target cells, and they take time to develop (typically 12 weeks after infection). Given the immense diversity of HIV strains worldwide, scientists are looking at ways to make better antibodies called highly or broadly neutralizing antibodies (which develop naturally over a longer period of time in a small fraction of people), often called the holy grail of HIV vaccines. Some terms you’ll hear used a lot in vaccine research are magnitude, duration, and breadth. Simply put, magnitude and duration have to do with how high and how long an immune response is, while breadth describes which parts of the virus (cell) are being affected.
with SIV had a unique effect, and about 50 percent of the monkeys who were vaccinated and then given a highly pathogenic form of SIV became infected, but over time eliminated all trace of the virus. During a press conference, Picker reported on additional findings showing that in early studies these CMV vectors also seem to work for TB, which is highly pathogenic and 100% fatal in monkeys. At 14 weeks, five out of seven monkeys seemed to be protected from TB, while nearly all of the control group infected with TB but not inoculated had already died. A CMV vector-based vaccine for malaria may also soon be studied. Picker was quick to point out, however, that every one of these studies costs two million dollars to conduct.
Building on RV144 As mentioned, in 2009 the RV144 study showed a modest protective effect of 31%, so a number of efforts are now underway which will attempt to build upon the results of RV144. Several follow-up studies to RV144 are helping to inform us on specific immune mechanisms and the effect of an additional boost at 6 or 12 months. The Pox-Protein Public-Private Partnership (P5) is a group of organizations planning future efficacy studies. Clinical trial implementation will be led by the HIV Vaccine Trials Network (HVTN) in South Africa, and in Thailand by the U.S. Military HIV Research Program (MHRP). There are now over two dozen ongoing safety nd immunogencity studies in 17 countries. Glenda Gray, Executive Director of the
Photo © Global HIV Vaccine Enterprise
Monkey business One of the most interesting findings presented at the conference came out of Dr. Louis Picker’s lab at Oregon Health & Science University. Reported in the journal Nature only a few weeks before the conference, an HIV/AIDS vaccine candidate developed by Picker and his team appears to have the ability to completely clear a non-human primate form of HIV, called simian immunodeficiency virus (SIV), which causes AIDS in monkeys. The Picker lab’s approach involves the use of cytomegalovirus, or CMV, a common virus that’s carried by a large percentage of the population. The researchers discovered that pairing CMV
‘No trials fail’: Glenda Gray (with Peter Gilbert) points out that every vaccine study offers insight regardless of its outcome. POSITIVELY AWARE
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Perinatal HIV Research Unit in Soweto, South Africa, who is leading one of the RV144 follow-up studies, said in a presentation at the conference that “no trials fail,” meaning that we always still learn something from a vaccine study even if does not meet its endpoint.
Ntando Yola: “It’s important that communities that are burdened have hope in the science.”
Community involvement Ntando Yola has worked for eight years in HIV prevention research at the Desmond Tutu HIV Foundation in Cape Town. In a plenary address at the conference, Yola spoke about his work with advocates and trial participants to bring them to the table, and how important it is to recognize the role of community and give them a voice. Yola said during a press conference, “It’s important that communities that are burdened have hope in the science.”
Unanswered questions Fauci says that questions remain as HIV vaccine development continues to advance, such as how do we move forward in the context of other fields of bio-medical prevention, and how do we identify those who are acutely infected, which is the best way to test a vaccine candidate?
Clearly, vaccines, if made to be affordable and accessible, are our best chance for bringing an end to the epidemic once and for all—and so the work continues. For more information and conference webcasts, go to vaccineenterprise. org/conference/2013/.
Photo © Global HIV Vaccine Enterprise
CONFERENCE UPDATE AIDS VACCINE 2013
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Hepatitis C Testing and Treatment:
Hope for the Future? Dr. Ronald Valdiserri discusses the challenges of getting patients into HCV treatment.
News from the 64th annual AASLD Meeting
Photo COURTESY OF AIDS.GOV
By Andrew Reynolds
N
early 10,000 attendees from around the world gathered in Washington, D.C. from November 1 to 5 for the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Hepatitis C (HCV) was featured prominently at this meeting, and there was significant buzz regarding the results of several clinical trials from a variety of different pharmaceutical companies. This brief report will not be an exhaustive review of the conference, but rather, it will cover some key highlights and findings from several posters and presentations.
HCV Screening and Treatment Cascade For all of the promise that many of the therapies hold for curing HCV, the United States has a long way to go to uncover new cases of HCV and link people to medical care. In a talk entitled “Ending the Silent Epidemic of Viral Hepatitis in the United States,� Ronald Valdiserri, MD, Deputy Assistant Secretary for Health, Infectious
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Diseases and Director, Office of HIV/AIDS and Infectious Disease Policy, highlighted the problem of increasing cases of HCV infections, and the challenges of linking people to care and successfully treating them once they are diagnosed with the virus. The most recent data presented (2011) shows an estimated 16,500 new HCV infections, a 45% increase from 2010. In a sobering comparison, Valdiserri reported the 2010 estimated HCV-related deaths at 16,627. With deaths out-pacing new infections, one might get the false impression of decreases in HCV rates in the United States. A more accurate picture of HCV in the United States came about when Dr. Valdiserri introduced the “U.S. HCV Treatment Cascade.” The cascade highlights that only 1.6 million or 50 percent of the 3.2 million people living with HCV have been diagnosed, with only 1 to 1.2 million or 32–38 percent of those with HCV being referred to medical care. For those who are engaged in medical care, only 220,000 to 360,000, or 7–11 percent of the total population living with HCV, have received treatment for the disease, and only 170,000 to 200,000, or 5-6 percent, have been successfully treated. As HCV therapies improve, it is widely accepted that more patients and medical providers will opt for initiating treatment. But as Dr. Valdiserri’s presentation demonstrates, the U.S. must improve its HCV screening and linkage to care infrastructure in order to ensure that all people living with HCV have access to these treatments so as to wipe out this curable disease.
Look to the cosmos Although we are one to two years away from FDA approval of interferon-free regimens for the treatment of genotype 1, patients, providers, and advocates eagerly await the time when these regimens become the standard of care for HCV treatment. While we wait, there will be off-label options (meaning providers can prescribe a drug for something other than its approved use) for a non-interferon treatment regimen based on data presented by Ira Jacobson for the COSMOS Study. COSMOS is a Phase 2 study, looking at the effectiveness of simeprevir with sofosbuvir with or without ribavirin in an interferon-free regimen. After 12 weeks of treatment, high sustained virologic response (SVR, when a person’s hepatitis C remains undetectable six months after treatment ends) rates ranging from 79 to 100% were reported, with results dependent upon degrees of cirrhosis and whether a person was treatment-naïve or a prior non-responder (those who failed to achieve a greater than 2-log drop in HCV viral load levels after 12 weeks of treatment). The regimen was very well tolerated with few adverse events reported. Although it is a small sample size, this regimen may provide some hope for people who do not want to take HCV treatment that includes interferon, and serve as a bridge for future FDA approved interferon-free regimens. As with most of the data reported here, the study was only in HIV-negative individuals.
Gilead’s sofosbuvir/ ledipasvir
The Next Wave of HCV Treatments
Gilead continues to develop a nonIn October 2013, an FDA advisory panel voted unanimously to recommend the approval of simeprevir and sofosbuvir for the treatment of HCV. Soon after, simeprevir (brand name Olysio) received approval from the FDA, and in December, approval of Sofosbuvir (brand name Sovaldi) was granted. Both drugs will be part of a triplemedication regimen that will include interferon and ribavirin (although Sovaldi can be used without interferon for the treatment of genotype 2 and 3). 26
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interferon-based HCV treatment featuring sofosbuvir with another one of their drugs, ledipasvir. Dr. Eric Lawitz presented results from the LONESTAR Study. Although the number of participants in this trial was small, it included treatment-naïve (never before on treatment) and prior PI (hep C protease inhibitor) failures, as well as including people with cirrhosis. The results were very promising, with 97 percent of patients achieving a sustained virologic response after 12 weeks of treatment. The
POSITIVELY AWARE
THE HCV TREATMENT Cascade 3.2 million in the U.S. have chronic hepatitis C infection
50% (1.6 million) are diagnosed
32–38% (1–1.2 million) referred to care
treatment regimen was very well tolerated, with fewer than five percent of participants reporting side effects, and there were very few adverse events reported. Research into this regimen continues, including looking at various treatment durations with and without ribavirin.
AbbVie’s Interferon-Free Regimen: Over 90% Cure Rates in Genotype 1b There were a number of noninterferon -based regimens from a number of different companies presented at AASLD. Only the results from AbbVie will be covered here, to serve as an example of what the future might hold. Eric Lawitz and colleagues presented on a two-drug, interferon- and ribavirin-free HCV treatment regimen comprised of ABT-450/r and ABT267 from the PEARL-I study, a Phase 2 clinical trial. Individuals in this study were all infected with genotype 1b, had no cirrhosis, nor were they co-infected with HIV or HBV. Additionally, the study included people who were either treatment-naïve or prior null responders. Patients took these two drugs for 12 weeks, with both groups achieving high SVR rates: 95.2% for treatment-naïve and 90% for prior null responders. The regimen was very well tolerated with relatively mild side effects reported and no one in the study stopped the treatment due to side effects or lab result abnormalities. In previous conferences, results from the AVIATOR Trial have shown that the treatment with these drugs (and another, ABT-333, with or without ribavirin) result in high SVR rates in patients with other HCV genotypes as well.
7–11% (200,000–360,000) 5–6% in treatment (170,000–200,000) successfully being treated
but drug to drug interactions and side effects can be challenging. New regimens are needed for HIV/HCV co-infected individuals, and there are several promising new treatments for this population. Dr. Mark Sulkowski reported on results from the PHOTON-1 study on the use of an all-oral treatment regimen of sofosbuvir and ribavirin for HIV-positive people with HCV genotype 1, 2, or 3. Individuals in this study were treatment-naïve for HCV, but taking HIV medications. At the end of 24 weeks of treatment, 76 percent of genotype 1 patients achieved an SVR, with 88 percent and 67 percent of genotypes 2 and 3 respectively achieving an SVR after 12 weeks of therapy. The HCV treatments were very well tolerated, drug to drug interactions do not appear to be a problem, and CD4 counts were not negatively impacted.
Conclusions The future of HCV treatments is one where the course of medications is shorter, easier to take with fewer side effects, and most importantly, with more people cured. With a number of presentations reporting SVR data in the 90 percentiles or higher, that future appears to be only a few years away. For more information on results from AASLD, as well as questions related to HCV prevention, care, and treatment, call The Support Partnership’s hepatitis C phone line at 1-877-HELP-4-HEP (1-877-435-7443).
HIV/HCV Co-Infection: New Treatment Options on the Horizon Currently, the only FDA approved HCV treatment for people living with HIV is the dual therapy regimen of interferon and ribavirin. There is off-label use of currently approved HCV protease inhibitors,
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Andrew Reynolds is the Hepatitis C Education Manager at Project Inform and facilitates several HCV support groups in the San Francisco Bay Area. He also works on the HELP4-HEP phoneline: call him if you have any questions.
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ABOUT PREZISTA
®
PREZISTA® is always taken with and at the same time as ritonavir (Norvir ®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food. • The use of other medicines active against HIV in combination with PREZISTA®/ritonavir (Norvir ®) may increase your ability to fight HIV. Your healthcare professional will work with you to find the right combination of HIV medicines • It is important that you remain under the care of your healthcare professional during treatment with PREZISTA® PREZISTA® does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA.® Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA® is right for you.
IMPORTANT SAFETY INFORMATION What is the most important information I should know about PREZISTA®? • PREZISTA® can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?” • PREZISTA® may cause liver problems. Some people taking PREZISTA,® together with Norvir ® (ritonavir), have developed liver problems which may be life-threatening. Your healthcare professional should do blood tests before and during your combination treatment with PREZISTA.® If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems • Tell your healthcare professional if you have any of these signs and symptoms of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite • PREZISTA® may cause a severe or life-threatening skin reaction or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare professional immediately if you develop a rash. However, stop taking PREZISTA® and ritonavir combination treatment and call your healthcare professional immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild Who should not take PREZISTA®? • Do not take PREZISTA® if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45,® Embolex,® Migranal®), ergonovine, ergotamine (Cafergot,® Ergomar ®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam, triazolam (Halcion®), the herbal supplement St. John’s wort (Hypericum perforatum), lovastatin (Mevacor,® Altoprev,® Advicor ®), simvastatin (Zocor,® Simcor,® Vytorin®), rifampin (Rifadin,® Rifater,®
Rifamate,® Rimactane®), sildenafil (Revatio®) when used to treat pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™), or telaprevir (Incivek™) • Before taking PREZISTA,® tell your healthcare professional if you are taking sildenafil (Viagra,® Revatio®), vardenafil (Levitra,® Staxyn®), tadalafil (Cialis,® Adcirca®), atorvastatin (Lipitor®), rosuvastatin (Crestor®), pravastatin (Pravachol®), or colchicine (Colcrys,® Col-Probenecid®). Tell your healthcare professional if you are taking estrogen-based contraceptives (birth control). PREZISTA® might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements. What should I tell my doctor before I take PREZISTA®? • Before taking PREZISTA,® tell your healthcare professional if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia • Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeeding — The effects of PREZISTA® on pregnant women or their unborn babies are not known. You and your healthcare professional will need to decide if taking PREZISTA® is right for you — Do not breastfeed. It is not known if PREZISTA® can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk What are the possible side effects of PREZISTA®? • High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA® • Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA.® The cause and long-term health effects of these conditions are not known at this time • Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden • The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA® or any other medicines without first talking to your healthcare professional You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please refer to the ritonavir (Norvir®) Product Information (PI and PPI) for additional information on precautionary measures. Please read accompanying Patient Information for PREZISTA® and discuss any questions you have with your doctor.
28PRZDTC0288R8
PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.
ily Once-Da
PREZISTA ^ EXPERIENCE
Discover the
®
Once-Daily PREZISTA® (darunavir) isn’t just an HIV treatment. It’s an HIV treatment experience as unique as you. That’s why you should ask your healthcare professional if the PREZISTA® Experience is right for you. Once-Daily PREZISTA® taken with ritonavir and in combination with other HIV medications can help lower your viral load and keep your HIV under control over the long term. In a clinical study* of almost 4 years (192 weeks), 7 out of 10 adults who had never taken HIV medications before maintained undetectable† viral loads with PREZISTA® plus ritonavir and Truvada.® Ask your healthcare professional about the PREZISTA® Experience. And be sure to visit DiscoverPREZISTA.com for tools and helpful information to find out if the PREZISTA® Experience might be right for you.
Please read the Important Safety Information and Patient Information on adjacent pages.
Snap a quick pic of our logo to show your doctor and get the conversation started. *A randomized open label Phase 3 trial comparing PREZISTA®/ritonavir 800/100 mg once daily (n=343) vs. Kaletra®/ritonavir 800/200 mg/day (n=346). †Undetectable was defined as a viral load of less than 50 copies per mL. Registered trademarks are the property of their respective owners.
Janssen Therapeutics, Division of Janssen Products, LP © Janssen Therapeutics, Division of Janssen Products, LP 2013 02/13 K28PRZ121037
IMPORTANT PATIENT INFORMATION PREZISTA (pre-ZIS-ta) (darunavir) Oral Suspension PREZISTA (pre-ZIS-ta) (darunavir) Tablets Read this Patient Information before you start taking PREZISTA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Also read the Patient Information leaflet for NORVIR® (ritonavir). What is the most important information I should know about PREZISTA? • PREZISTA can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with PREZISTA. See the section “Who should not take PREZISTA?” • PREZISTA may cause liver problems. Some people taking PREZISTA in combination with NORVIR® (ritonavir) have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. • Tell your healthcare provider if you have any of the below signs and symptoms of liver problems. • Dark (tea colored) urine • yellowing of your skin or whites of your eyes • pale colored stools (bowel movements) • nausea • vomiting • pain or tenderness on your right side below your ribs • loss of appetite PREZISTA may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. However, stop taking PREZISTA and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with symptoms below: • fever • tiredness • muscle or joint pain • blisters or skin lesions • mouth sores or ulcers • red or inflamed eyes, like “pink eye” (conjunctivitis) Rash occurred more often in people taking PREZISTA and raltegravir together than with either drug separately, but was generally mild. See “What are the possible side effects of PREZISTA?” for more information about side effects. What is PREZISTA? PREZISTA is a prescription anti-HIV medicine used with ritonavir and other anti-HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a protease inhibitor. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). When used with other HIV medicines, PREZISTA may help to reduce the amount of HIV in your blood (called “viral load”). PREZISTA may also help to increase the number of white blood cells called CD4 (T) cell which help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections). PREZISTA does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA. Avoid doing things that can spread HIV-1 infection. • Do not share needles or other injection equipment. • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• D o not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people. Who should not take PREZISTA? Do not take PREZISTA with any of the following medicines: • alfuzosin (Uroxatral®) • dihydroergotamine (D.H.E. 45®, Embolex®, Migranal®), ergonovine, ergotamine (Cafergot®, Ergomar®) methylergonovine • cisapride • pimozide (Orap®) • oral midazolam, triazolam (Halcion®) • the herbal supplement St. John’s Wort (Hypericum perforatum) • the cholesterol lowering medicines lovastatin (Mevacor®, Altoprev®, Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®) • rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) • sildenafil (Revatio®) only when used for the treatment of pulmonary arterial hypertension. Serious problems can happen if you take any of these medicines with PREZISTA. What should I tell my doctor before I take PREZISTA? PREZISTA may not be right for you. Before taking PREZISTA, tell your healthcare provider if you: • have liver problems, including hepatitis B or hepatitis C • are allergic to sulfa medicines • have high blood sugar (diabetes) • have hemophilia • are pregnant or planning to become pregnant. It is not known if PREZISTA will harm your unborn baby. Pregnancy Registry: You and your healthcare provider will need to decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider about how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the registry is follow the health of you and your baby. • are breastfeeding or plan to breastfeed. Do not breastfeed. We do not know if PREZISTA can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk. Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Using PREZISTA and certain other medicines may affect each other causing serious side effects. PREZISTA may affect the way other medicines work and other medicines may affect how PREZISTA works. Especially tell your healthcare provider if you take: • other medicine to treat HIV • estrogen-based contraceptives (birth control). PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom. • medicine for your heart such as bepridil, lidocaine (Xylocaine Viscous®), quinidine (Nuedexta®), amiodarone (Pacerone®, Cardarone®), digoxin (Lanoxin®), flecainide (Tambocor®), propafenone (Rythmol®) • warfarin (Coumadin®, Jantoven®) • medicine for seizures such as carbamazepine (Carbatrol®, Equetro®, Tegretol®, Epitol®), phenobarbital, phenytoin (Dilantin®, Phenytek®) • medicine for depression such as trazadone and desipramine (Norpramin®) • clarithromycin (Prevpac®, Biaxin®) • medicine for fungal infections such as ketoconazole (Nizoral®), itraconazole (Sporanox®, Onmel®), voriconazole (VFend®) • colchicine (Colcrys®, Col-Probenecid®) • rifabutin (Mycobutin®) • medicine used to treat blood pressure, a heart attack, heart failure, or to lower pressure in the eye such as metoprolol (Lopressor®, Toprol-XL®), timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®, Combigan®) • midazolam administered by injection • medicine for heart disease such as felodipine (Plendil®), nifedipine (Procardia®, Adalat CC®, Afeditab CR®), nicardipine (Cardene®) • steroids such as dexamethasone, fluticasone (Advair Diskus®, Veramyst®, Flovent®, Flonase®) • bosentan (Tracleer®) • medicine to treat chronic hepatitis C such as boceprevir (VictrelisTM), telaprevir (IncivekTM)
IMPORTANT PATIENT INFORMATION • m edicine for cholesterol such as pravastatin (Pravachol®), atorvastatin (Lipitor®), rosuvastatin (Crestor®) • medicine to prevent organ transplant failure such as cyclosporine (Gengraf®, Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®) • salmeterol (Advair®, Serevent®) • medicine for narcotic withdrawal such as methadone (Methadose®, Dolophine Hydrochloride), buprenorphine (Butrans®, Buprenex®, Subutex®), buprenorphine/naloxone (Suboxone®) • medicine to treat schizophrenia such as risperidone (Risperdal®), thioridazine • medicine to treat erectile dysfunction or pulmonary hypertension such as sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), tadalafil (Cialis®, Adcirca®) • medicine to treat anxiety, depression or panic disorder such as sertraline (Zoloft®), paroxetine (Paxil®, Pexeva®) • medicine to treat malaria such as artemether/lumefantrine (Coartem®) This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. Do not start any new medicines while you are taking PREZISTA without first talking with your healthcare provider. How should I take PREZISTA? • Take PREZISTA every day exactly as prescribed by your healthcare provider. • You must take ritonavir (NORVIR®) at the same time as PREZISTA. • Do not change your dose of PREZISTA or stop treatment without talking to your healthcare provider first. • Take PREZISTA and ritonavir (NORVIR®) with food. • Swallow PREZISTA tablets whole with a drink. If you have difficulty swallowing PREZISTA tablets, PREZISTA oral suspension is also available. Your health care provider will help decide whether PREZISTA tablets or oral suspension is right for you. • PREZISTA oral suspension should be given with the supplied oral dosing syringe. Shake the suspension well before each use. See the Instructions for Use that come with PREZISTA oral suspension for information about the right way to prepare and take a dose. • If your prescribed dose of PREZISTA oral suspension is more than 6 mL, you will need to divide the dose. Follow the instructions given to you by your healthcare provider or pharmacist about how to divide the dose. Ask your healthcare provider or pharmacist if you are not sure. • If you take too much PREZISTA, call your healthcare provider or go to the nearest hospital emergency room right away. What should I do if I miss a dose? People who take PREZISTA one time a day: • If you miss a dose of PREZISTA by less than 12 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time. • If you miss a dose of PREZISTA by more than 12 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time. People who take PREZISTA two times a day • If you miss a dose of PREZISTA by less than 6 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time. • If you miss a dose of PREZISTA by more than 6 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time. If a dose of PREZISTA is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZISTA at any one time. What are the possible side effects of PREZISTA? PREZISTA can cause side effects including: • See “What is the most important information I should know about PREZISTA?” • D iabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including PREZISTA can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking PREZISTA. • Changes in body fat. These changes can happen in people who take antiretroviral therapy. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and longterm health effects of these conditions are not known.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV medicine. • Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including PREZISTA. The most common side effects of PREZISTA include: • diarrhea • headache • nausea • abdominal pain • rash • vomiting Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PREZISTA. For more information, ask your health care provider. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. How should I store PREZISTA? • Store PREZISTA oral suspension and tablets at room temperature [77°F (25°C)]. • Do not refrigerate or freeze PREZISTA oral suspension. • Keep PREZISTA away from high heat. • PREZISTA oral suspension should be stored in the original container. Keep PREZISTA and all medicines out of the reach of children. General information about PREZISTA Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZISTA for a condition for which it was not prescribed. Do not give PREZISTA to other people even if they have the same condition you have. It may harm them. This leaflet summarizes the most important information about PREZISTA. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about PREZISTA that is written for health professionals. For more information, call 1-800-526-7736. What are the ingredients in PREZISTA? Active ingredient: darunavir Inactive ingredients: PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric acid monohydrate, sucralose, masking flavor, strawberry cream flavor, hydrochloric acid (for pH adjustment), purified water. PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® White (polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide). PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® Orange (FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide). PREZISTA 800 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, hypromellose. The film coating contains: OPADRY® Dark Red (iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide). This Patient Information has been approved by the U.S Food and Drug Administration. Manufactured by: PREZISTA Oral Suspension PREZISTA Tablets Janssen Pharmaceutica, N.V. Janssen Ortho LLC, Beerse, Belgium Gurabo, PR 00778 Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560 Revised: April 2013 NORVIR® is a registered trademark of its respective owner. PREZISTA® is a registered trademark of Janssen Pharmaceuticals © Janssen Pharmaceuticals, Inc. 2006 991772P
Take two pills and
call your pharmacist in the morning
The CDC looks at improving HIV care through pharmacies By Enid Vázquez
H
IV is a complicated condition requiring expert care, but how
to access that care is another question.
Shifting some of that expertise to the pharmacy would be a boon to ending the epidemic. In November, the Centers for Disease Control and Prevention (CDC) awarded a $2.4 million grant to see if a specific type of pharmacy work can improve medical care for people living with HIV. The CDC leveraged an additional $1 million of in-kind services by partnering with Walgreens Pharmacy. Specifically, the CDC is looking at the concept of medication therapy management, or MTM. In MTM, a pharmacist talks with patients to examine all of their medical conditions and needs, including such things as nutrition and exercise, helping to create a treatment plan and then communicating that to the patient and their provider. Which regimen, for example, might be best across different disease states for the patient? Not a minor concern as people with HIV live longer and develop other medical conditions, sometimes seeing providers who don’t communicate with one another. “MTM is the most comprehensive service we could provide if we had all the time and resources we need,” said principal investigator Patrick Clay, PharmD and professor of pharmacotherapy at the University of North Texas Health Science Center (UNTHSC). Dr. Clay has dedicated his career to HIV care, but he and his staff know the statistics: more and more HIV patients with fewer and fewer HIV specialists. “There’s not a huge influx of HIV care providers coming in,” he said. “They’re retiring and fewer are taking up the slack. At the same time, the complexity of treating HIV is greater than other diseases and 32
JA N UA RY + FEB R UA RY 2 014
the reimbursement is less, and won’t cover what it takes to treat. “Instead of creating HIV physicians out of thin air,” Dr. Clay continued, “why not look to the pharmacist to take some of the less complicated work involved—that to me is the exciting part, showing the capability and the quality of the pharmacy.” “Pharmacists are underused health providers and we live in the community,” said Glen Pietrandoni, RPh, AAHIVP, senior manager in virology for Walgreens Pharmacy. “Data from the American Pharmacists Association shows that 90% of Americans live within three miles of a pharmacy,” added Dr. Clay, “and you can’t say that about any other health profession.” Moreover, Walgreens estimates that 90% of people with HIV have access to one of their HIV-specialty pharmacists. Dr. Clay also hopes the in-depth conversations with patients will help keep them in care, overcoming a significant problem in the U.S. epidemic today. Like other experts, he believes HIV can now be a lifelong, chronic condition, but only if patients can tolerate and adhere to “arguably the most complex drug regimen ever used in medicine.” That, he says, requires harmony among many different parts, including the medical providers involved. Included in Dr. Clay’s team are HIV and MTM experts, healthcare economists, and capacity building specialists from HealthHIV and the Universities of Kentucky, Minnesota, and Nebraska and Northwestern University. This group, working with Walgreens and the CDC, will identify 10 sites and 1,000 patients around the country to take part in this project.
POSITIVELY AWARE
The CDC had approached Walgreens about a private/public partnership in 2012. “They knew of our interest in working with organizations,” Pietrandoni said. “We have worked with the Kaiser Family Foundation, with AIDS United.” (Not to mention longtime sponsorship of Positively Aware’s annual HIV drug chart and donating editorial support, including articles and reviews of the drug guide itself.) “CDC knows about Walgreens’ commitment to end AIDS. Pharmacists can do a whole lot more than just dispense medications. We started an immunization program five years ago and we probably now do more immunizations than clinics,” Pietrandoni said. HIV, however, requires much more extra training, “like learning to speak a foreign language, the language of HIV, so to speak.” “We’re using the project to really embellish our MTM program, especially in underserved and minority communities, including rural patients [making up at least 10 percent of the patients participating in the program],” he said. “We have a program that looks at patients holistically and not just their medications, but the patient’s whole health.” An MTM pharmacist also stays on top of a patient’s care, following the patient’s response to medical treatment, watching out for opportunistic infections, and so forth. The project will include an evaluation of communication patterns between patients and their physicians and pharmacists. “With this program, we delve deeper into HIV: blood pressure, diabetes, smoking, and so on, all in the context of HIV,” said Pietrandoni. “We do HIV work every day. I don’t know of anyone else [as a commercial pharmacy] who does that.”
2 5 Y EARS O F B EING P OSITI V EL Y A W ARE
How One Person can
make a difference
We were here: TPAN FOUNDER CHRIS CLASON TAKING PART IN CHicago’s GAY PRIDE PARADE IN 1988.
Chris Clason’s inspiring vision led to the birth of TPAN and Positively Aware By Enid Vázquez
Photo COURTESY OF GERBER/HART LIBRARY and Archives, Bernard Brommel/Charles Cox collection
B
efore there was Positively Aware there was TPA News. And before TPA News there was a young gay man turned activist named Chris Clason.
His story is legendary: How he tested HIV-positive in 1987 and searched for support, how he was told there was nothing for people who were still healthy and to come back when he had AIDS. Not only did he not accept that, but he decided to create the support group he wanted on his own. So he took out a classified ad in Gay Chicago magazine, inviting other people with HIV to join him in a quest for information and support. On June 16, 1987, in his living room with 15 other men living with HIV, Test Positive Aware Network was born. To this day, more than two decades after his peaceful death on Christmas Day of 1991, at the age of 38, Test Positive Aware Network continues to save lives and provide emotional support. In Clason’s words from the August 1991 issue of PA, “I was mostly interested
in information, but I also wanted to hear personal experiences. I did not want a gripe session. I wanted to hear about people’s problems and hardships but with the idea that the sharing could lead to an answer or solution; someone else may have successfully handled that problem and could share their experience.” The organization he founded has become much more than a twice-weekly support group. TPAN provides case management; syringe exchange and naloxone (a drug used to counteract an opiate overdose); HIV and hepatitis C testing; condom distribution; extensive educational offerings; many support programs, including those for people in recovery;
and an AIDS ride, as well as a burlesque show fundraiser (Clason, a born performer, would have loved Chicago Takes Off). The AIDS Legal Council of Chicago offers a drop-in clinic twice a month, as does a local acupuncturist. TPAN’s crowning jewel is the magazine which grew from TPA News, a thin, mimeographed newsletter stapled in the corner, written by Clason himself. Positively Aware now goes to every state in the nation and has readers around the world and online. The original TPA News listed local clinical trials and discussed potential natural and holistic therapies, and was a gold mine of often life-saving information.
Questions Bill Rydwels, one of those first
16 men who met in Clason’s living room,
Author’s note: For its first 10 years, Test positive aware network was often referred to as “TPA” or “TPA Network,” Until it was changed to “TPAN.”
POSITIVELY AWARE
JA N UA RY + FEB R UA RY 2 014
33
2 5 Y EARS O F B EING
Aware “Chris was concerned about
the antivirals; he was not pro-drugs,” early member Michael Blackwell recalls. “There are a fraction of people who still believe that some of our friends and loved ones died because of those drugs, because of the toxicities. He was more interested in holistic therapies, in energy work. But he was respectful. He agreed to disagree. He never dictated, he always provided options.” “Thank God for AZT,” said founding member Bernard Brommel. He and his partner Randy joined the first AZT study, but his partner got the placebo, developed AIDS, and died within three months. Brommel had earlier been in an interferon study he learned about through the meetings, and he participated in seven 34
JA N UA RY + FEB R UA RY 2 014
1987: Some of TPAN’s original members gather at Chicago’s lakefront.
or eight clinical trials at Northwestern University with Dr. Robert Murphy. He believes they saved his life. “People who got to be in one of those interferon studies were lucky. Lucky, lucky, lucky,” said Lisa Congleton, who provided support to the members (an “angel,” said Brommel). “Interferon cost thousands of dollars a month. If you didn’t have the money, you basically got your life in order and you died. That’s the way it was.” Congleton said the men in the TPA group were like “little old ladies” discussing their ailments. But it wasn’t trivial. “They were comparing notes because their lives depended on it. Here’s the other thing: at that time there were only a handful of doctors available for them. There was a gay doctor at Cook County [Hospital], Ron Stall, who later died of HIV. These doctors were shooting in the dark. There was no information.” Rydwels said, “I had criticized people using crystals, believing there were energy points on their body. I had to change my mind because if you did anything positive to try to find a cure, you were working against the virus and you were helping yourself. There was nothing that was definite and had a clinical trial behind it.”
POSITIVELY AWARE
Community Blackwell remembers that “as
someone who’s getting their status and getting all freaked out, I was completely reassured by Chris. He was a very emotionally generous person, able to calm people down and make them feel better. He made all that panic melt away. It was because of him I got involved. He inspired me and he challenged me.” Rydwels agreed, saying, “No one else had what he had. He made you feel like you were becoming a part of his family.” Brommel, a psychiatrist, now retired, said Clason was very engaging, wanting to know both your interests and what you wanted to contribute. “Those were pretty dark days. If you had some training, that was the time to help. He facilitated it all and encouraged us. “Those days were so bleak,” he said. “There were absolutely no reliable meds. Yes, some were flying off to California or New York for wild treatments—if they had the money for a ticket and everything else. Most of the people I encountered were desperate and full of fear.” Former TPAN president Charles Morris said, “It was a time when people were very despairing and there was no hope and no
Photo: Billy Howard from Epitaphs for the Living—Words and Images in the Time of AIDS
recalls that it was at that very first meeting during which TPAN was created that Chris Clason said, “We have to find answers for ourselves.” Clason also lined up doctors and lawyers to come speak to the membership. The doctors offered both knowledge and hope. Rydwels remembers them promising, “We’ll find drugs for this.” There was so much to discuss, topics that are still relevant today: What research was taking place? Should they tell their employer they had HIV? How do they tell their families? What arrangements could be made for their death? At the time, many hospitals refused to treat people with AIDS and most funeral homes refused to bury their bodies. Chris Clason turned out to be right about the need to search for information. One of the most striking examples of this was the experience of treasurer Thom Hudson, another founding member and a surgical nurse, who traveled to Australia where he learned that patients were taking half the AZT dose that was given in this country. He asked the doctors at a meeting, “Why are we taking the big doses every four hours, waking up in the middle of the night, and having all the horrible side effects, when they’re taking half-doses with no side effects?” “The doctors said, ‘Oh, the people in Australia don’t know what they’re doing,’” says Rydwels. Later, doses were lowered in the U.S. “Thank God he talked with them, because they were killing us.”
P OSITI V ELY AWARE
place to go, and information was sketchy, at best. You realized, ‘Oh, I’m not alone.’ Other people are going through the same things. There was a sense of belonging and shared experiences, without which there would have been a sense of isolation. And there was information: high doses of vitamin C, hydrogen peroxide. People were trying all these things.”
Secrecy “It was a very different land-
scape to what you know today,” said Lisa Congleton, “so it was an incredibly courageous thing for Chris Clason to do, to gather people who were HIV-positive and hold a meeting in a public place. “Some people wouldn’t come to TPA,” she said. “Their job might be on the line. They might be seen. There was hysteria and a justified paranoia. Michael [Blackwell] and I had friends who got death threats from the staff at Cook County [hospital, where a great number of AIDS patients were seen]. It didn’t shock us. That was the context in which Chris Clason started this.” “When he gathered that first group,” said Brommel, “that took guts and courage, because everything back then was anonymous. Everything was first name only. We were afraid of insurance companies. You didn’t know where TPA met until you had gone through a screening. There was no phone listed. You had to know who to ask or find out through word of mouth. For years there was no name on our door. People were afraid of being seen coming to our meetings.”
Laughter before death Everyone remembered Chris
what we did to have fun, because we could forget who died that week. We would say good-bye at the end of every meeting. That was very sad. It was the most serious thing we did, but people welcomed it because it became a community of loss.”
Cost of living “It wasn’t all roses being on the
first board that first year,” said Brommel. “Like anything else, people had a political axe to grind. And there was no money. Running those ads must have cost Chris a small fortune. Hannah [Hedrick, another “angel”] and I would often cover the rent, and Chris’s parents helped pay for the newsletter and meeting notes to hand out. We passed the hat at every meeting.” Chris Clason ran TPAN for years with only other volunteers before money was raised for a staff, just as he became ill and moved home to be with his family. Brommel led a campaign to have memorial gifts made to TPAN, especially after seeing the men’s property go to families that had disowned them.
‘Committed to Living’ Chris Clason had very early on
coined TPAN’s motto, Committed to Living, which continues to represent everything the agency does. In that very first mimeographed newsletter, he was prophetic, writing words that are still relevant to the epidemic today. “TPA has become more than a data Pages of History: The Test Positive Aware newsletter was first issued in September 1987, and evolved into Positively Aware in November 1990.
exchange. Members have expressed needs on many levels and TPA’s agenda is tailored to address personal, social, and political concerns, as well as medical and scientific issues. We have learned that there is more to life than T-cell counts alone. We are discovering inner strengths and the courage to face head-on all aspects of HIV infection. We have begun to explore new avenues of personal growth: to open our minds to all possibilities; to open our hearts to people who share our concerns, if not our beliefs, experiences, or desires.” (From Test Positive Aware Newsletter, September 1987) He ended that column by saying, “I hope that we can depend on your involvement to help TPA reach its full potential.” “The brilliance of his programs and thinking amaze me,” said Bill Rydwels. “And he was a caterer. Bernie and I wrote a letter to the Board, asking that a building be named after Chris. God bless what he did. He helped everyone. Even after 20 years, he still touches many people, and his newsletter is now a national magazine.” Said Charles Morris, now living in Florida, “My partner and I go to our doctor and Positively Aware is there. When I see that, it’s so good to know that it’s still going strong.” Read more about Chris Clason’s life and
vision, and the early days of TPAN, from these interviews as well as articles by and about him in this edition online and in the author’s blog, Tell It to Enid, for a discussion with his sister Phyllis Stover and nieces Jill Stover Martinez and Karol Clason.
Clason for his effusive personality and for making them laugh, and they loved his drag persona, Beverly Del Vecchio. “He was a stunning beauty in drag,” said Bill Rydwels. “Some said, ‘Sorry, we don’t want people to have that kind of idea about us.’ It was stupid. We were pariahs and we didn’t want to be worse pariahs.” “He loved Halloween parties because he could dress up,” said Bernie Brommel. “I went to a party and wondered, ‘Who’s this ravaging, red-haired beauty in stiletto heels?’ I was there a long time before I realized it was Chris. “That’s what we did to laugh. That’s
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WHOLISTIC PICTURE
O
health-care/are-insurers-finding-a-way-around-obamacarepreexisting-conditions-protections-20131107), the ACA
Photo: Cheryl Mann
sUE SALTMARSH
Making Lemon-AID
ver the course of the almost five years it’s taken for implementation of the most anticipated provisions of the Affordable Care Act (ACA), we’ve learned many new terms—individual mandate, highrisk pool, essential health benefits, etc. And we’ve also heard about “cherry-picking,” the practice of insurance companies to reject the elderly and already sick in favor of insuring the “cherries”—young, healthy people. They used to do this via “pre-existing condition” clauses, by charging women more than men, and by dropping people when they got sicker or had a medical crisis. The ACA has supposedly outlawed those criteria and replaced that kind of cherry-picking with the individual mandate which makes it necessary for every person to have health insurance. The individual mandate, creepily called the “individual shared responsibility provision,” however, has nothing to do with “shared responsibility” and much to do with protecting profits for the insurance companies. But the penalties that “irresponsible” individuals would have to pay for remaining uninsured increase from $95 the first year to $325 in 2015, maximizing to $695 in 2016. Even at the 2016 rate, you’d pay less for the penalty than you would for two monthly premiums if you make 400% or more of Federal Poverty Line (FPL), which would be about $45,000 for one. So there might be many “cherries” out there who would pick paying the penalty over having their pockets picked. Forced out of the cherry-picking business, insurers are now moving to “lemons,” especially HIV-positive ones. This time, though, dropping them is the preferred action. According to the National Journal (nationaljournal.com/
“prohibits insurers from denying coverage to individuals with preexisting conditions, but some companies may be limiting their prescription drug offerings to steer HIV patients to other plans.” “We’re seeing policies in place by insurance companies that certainly look like they are intended to make plans look less attractive to patients with HIV,” said John Peller, vice president of policy at AIDS Foundation of Chicago. There are two main concerns about this, according to the National Journal—“that companies aren’t offering single-tablet regimens [STRs] for HIV patients in
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their Quality Health Plan [QHP, the benchmark for ACA exchange plans] formularies [the list of prescription medications covered], and that there is a lack of transparency as far as what the plans offer to individuals with the disease.” So before you buy a policy, have a list of all your prescriptions and check to make sure they’re covered! Though STRs are indeed expensive, there’s data that show that they reduce hospitalizations by 23% and medical costs by 17%, not to mention the much greater rate of adherence if people only have to take one pill once a day. Greater adherence equals suppressed viral load, equals less risk of transmission and fewer new infections. Much like syringe exchange programs, STRs provide the best bang for the buck, in treatment and also as a tool of prevention. I’ve predicted since 2010 that instead of discriminating against the people with the disease via pre-existing conditions clauses, they would begin to discriminate against the disease itself. I believe this is the first wave of that discrimination. I’m horrified at the potential resurgence of the epidemic that this could cause. As someone living with a condition that requires me to take six medications two or three times a day, I wonder how long it will be before non-HIV drugs that alleviate the nausea of chemo and radiation are dropped or the drugs that control blood sugar without insulin injections or the blood pressure drugs that keep my throat from exploding. Because whether we have HIV, cancer, diabetes, or primary biliary cirrhosis, to the insurance companies, we’re just lemons. I say it’s up to us to make lemon-aid and ensure that everyone gets the medications they need.They want “individual shared responsibility?” We can do that too. By all of us paying into a healthcare trust fund; by being responsible for ourselves and each other; by removing all financial barriers; by ending racial and socioeconomic health care disparities; by freeing employers from the expense of insuring their workers; by never having to pay a premium, deductible, co-pays or co-insurance again—all of that is within our grasp with true universal healthcare. What more has to happen before we close our fists around it and don’t let go?
Because whether we have HIV, cancer, diabetes, or primary biliary cirrhosis, to the insurance companies, we’re just lemons.
Breathe deep, live long.
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HIV researcher daria Hazuda: “As a field, I think there are a lot of really interesting ideas—it’s exciting!”
explorING POSSIBILITIES Two HIV researchers talk about their work and what lies ahead
Photo:
By Jeff Berry
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P
ositively Aware Editor Jeff Berry recently sat down with Daria Hazuda and Mike Miller, two leading researchers at Merck Pharmaceuticals. Hazuda heads up infectious disease research at Merck that includes HIV, hepatitis C, and other antivirals, as well as antibiotics and antifungals, and Mike Miller, who works for Hazuda, has responsibility for all the infectious disease work and his current responsibility is HIVrelated discoveries based on earlier HIV programs.
Jeff Berry: Daria, how did you become interested or involved in infectious disease?
So you’ve been at Merck 16 years. Daria, how long have you been there?
DH: I first got involved by working on herpes viruses, believe it or not. When I was post-doc at SmithKline, a friend told me about a job in the virology group working on inhibitors of herpes virus replication. I was not a virologist, I knew nothing about infectious disease, but I was trained in basic chemistry, nucleic acids—the nature of the project. It was a good fit for my training, so I started learning about virology. It was the mid-1990s and I thought, “Geez, if I’m going to be working in virology, there’s really only one virus that’s most important to be working on,” so I asked to transfer to work on new HIV drugs. They said, “Well, you’re not really a virologist, but you know something about biochemistry of nucleic acids, and we have this really hard project called integrase and maybe you could do something on this.” And that’s how I started the integrase program in the mid-’90s.
DH: Oh, 20-some years? I have no idea. It seems like only yesterday [everybody laughs]. I remember my first big HIV conference was the big Vancouver meeting. We had a first-time triple combination therapy and people were talking about a cure! I’d just started the integrase program, we were finally having a little bit of success, and I remember we were sitting in the audience saying, “Oh, gosh, now we’re going to have to find some other virus to work on.”
Photo COURTESY OF MERCK
Mike, how about you?
MM: Well, I trained actually as a microbiologist and immunologist. I was interested in infectious disease and I went to the Salk Institute to Rick Bushman’s lab to work on integrase. This was in the early ’90s and HIV was really sort of a huge problem, we didn’t have any of the protease inhibitors yet. The academic world is fantastic at uncovering knowledge and everything, but it became clear that if you were going to have an impact, a tangible impact, that it had to be up to the companies to do that. Fortunately, Daria was looking for somebody at about that time, so it was a great opportunity for me to be able to come [to Merck]. That was 16 years ago and I’ve been working on HIV ever since.
Was that when you first got interested in cure research? DH: No—I first started getting interested in
cure research when I met David Margolis at one of the drug resistance workshops. I was standing by his poster, arguing with him vociferously about whether or not there was true latency in HIV. That’s when we first started a loose collaboration—we were giving him some of the early integrase inhibitors so he could truly demonstrate, in some of these in vitro systems, that the virus was integrated and that there was a true latent state. Ultimately, he convinced me—that there was a latent state and that latency did matter and then, could we work together to see if we could do something about it. So Mike, integrase inhibitors were a huge advance in HIV obviously, but what do you think was the big advance with integrase— was it that it was a new class of drug, was it the target, or the fact that it was more tolerable, easier to take? MM: At the time raltegravir [Isentress] was approved, it was a new class and it came at
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You’ve probably seen a lot of failures in your work, things that don’t work the way you expected them to. How do you handle that? DH: Most things we do don’t succeed. But if you don’t learn from that, it’s sort of a waste of effort. So whenever you think about your experiment or clinical study, you have to plan for the eventuality that it might not work, so knowing that reality in advance and thinking about how much information you can capture, because that information may be really valuable in helping you design a better molecule, or think about the approach differently—if you don’t do that, you just waste a lot of time.
Is it true that something like 90% of drugs don’t make it through the process? MM: That’s just sort of the tip of the ice-
berg. There are other failures along the way that are a lower profile, but they set you back further. DH: One of the first things that I learned when I came to Merck was, “If you always do what you’ve always done, you’ll always get what you’ve always got.”
So, getting to the cure, what’s your biggest challenge right now? DH: As a field, I think there are a lot of really interesting ideas—it’s exciting. I think the biggest challenge is being able to measure a meaningful enough effect so that you feel you’ve done something significant to the reservoir. I think that’s the biggest challenge. Secondary to that, having animal models that might be predictive.
Mike, you’re working on that as well? 44
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MM: I am. One of the things that keeps me up at night is how are you going to measure in the clinic to show whether you’ve had any benefit, short of stopping therapy and seeing if it’s a home run. Progress is more likely to be incremental, so we need better tools to study that. I think one of the big challenges right now, and opportunities, is to really study those patients whose reservoirs were eliminated and everything we can get out of understanding why those patients now seem to be free of HIV. I think that will put us in a better position to know how we can intervene to get that result.
I hear a lot of comments in the community about why pharma would want to find a cure when they’re making a good living on the drugs that treat HIV, they’re not interested in finding a cure. Merck researcher Mike Miller. DH: You know we make a lot of the vac-
cines that prevent a disease; and we make hep C drugs that will cure people with amazing results now—we may be able to eradicate the disease. I would love to be able to say that about HIV in my life. MM: To be involved in something like that
is the kind of thing that drives people and I’ve never bought the idea that companies, people, would withhold that sort of thing for financial reasons. The benefits to the company and to the people would just be immense. Another thing is that as researchers, you’re excited by the work and research. Funding is important, obviously, but that’s not your main motivator. DH: Absolutely. Just meeting people who’ve taken Isentress, especially people who participated in the benchmark study— some of them wouldn’t be alive today…it’s incredibly powerful. A lot of what we do in the very early stages never sees the light of day, so to have participated in something like that is just amazing. MM: We’ve received lots of letters with people’s stories about how they enrolled in one of the final phases and had an amazing turnaround. Those are the kind of things we send around to all the scientists in the lab. You don’t get to meet the patients all the time—it connects what they do on a day to
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day basis, which can be sort of hard work and boring at the lab bench, to what the purpose is at the end of the day. This would be a great opportunity to talk about any kind of cure research that’s being done through the Martin Delaney Collaboratory, how that kind of structure works and more specifically about the work that you’re doing. DH: Understanding latency and reservoirs is one of the most complicated areas of research in HIV. Several years ago, when we started talking to various people, it became obvious pretty quickly that although there were a lot of people working in cure research, these efforts would really benefit by being more coordinated. So that’s sort of where the original idea came about—that we needed to have some sort of larger collaborative effort where people could share what they were doing and ideas could be explored in a space that was a little more risk-enabling. In the environment of a pharmaceutical company, as well as in the academic environment, people are motivated to produce results because that’s how they get rewarded. This kind of research is very risky, you’re not necessarily going to see immediate results in what you’re doing, and so it becomes very hard for people to invest as much as needed because they’re
Photos COURTESY OF MERCK
a time when a new class was desperately needed because people had T-20 (Fuzeon), but they had a lot of tolerability issues. The tolerability part really came later. You could look at some of the properties, and say you kind of set that kind of class up for better tolerability, like the fact that it’s metabolized by a different pathway, which may play into a better safety profile. But I think, at the time, the biggest piece was that it was a new class at a time when people desperately needed it.
A research immunologist removes an HIV vaccine clinical sample from liquid nitrogen freezer storage.
not necessarily going to see those efforts be rewarded for a long time. That’s why the collaboratory is so important—it allows people to do things together that might be a little riskier because they don’t have to worry about writing the next RO1 [NIH research grant] or justifying some of the experiments to corporate management, because we share the risk. It also allows us to take advantage of the advances that are occurring much more rapidly. A recent example is one of the people in the CARE collaboratory came up with a really nice primary cell latency system, and because we’re part of the collaboratory we learned about this early on, and we were able to collaborate with them and adopt it and bring it into Merck and implement it here. Whereas if we weren’t part of the collaboratory you’d hear about it in a meeting, or you’d wait for the publication, and it would just take much longer. So it’s that kind of free exchange of ideas and early access to advances, such as what we’re doing with small molecule screening, providing those compounds to people in the collaboratory to study, and to help figure out the mechanism of action, the same thing is happening. By having that information investigators in the collaboratory can facilitate some of that basic understanding of how our molecules are working much faster. So things are actually working in the
way they should and the end result is we have things faster than we would otherwise. Is it advancing fast enough? It’s never fast enough for me [laughs], but it’s advancing much faster than if people were not working together. That’s not the usual model for academics and pharmaceutical companies—are there still certain things you don’t share? DH: Oh, everybody certainly keeps some things more proprietary. I think that’s true on both the academic side as well as on the industry side. The academic investigators still need to have some information that’s unique to them so that they can continue to get funding for their academic lab. It is a balance, but overall I think things are working quite well, and I think the field is benefiting in ways that we had hoped. We can always do better, it’s been a learning experience for all of us. MM: Yes, we speak different languages sometimes. There’s so much to this problem—we don’t even know what we don’t know and that’s why it’s really critical to have this work that spans the whole gamut from the earliest academic studies to what we’re doing, which is more translational, because we all need to work together to define the problem. Once we understand the problem we’ll be in a position where
we’d like to address it. I think it also encourages early adoption of better technologies because you don’t have as much time when people are working independently on different ways to do the same thing—sometimes people can get entrenched in their own methodology and by having that early disclosure, I’ve seen cases where people are like, ‘Oh! That works better than what we were doing,’ so it encourages that sharing of best practices across labs at an early stage. What is a normal day for you? MM: I don’t have a typical day. We’ve got a lot of projects, things going into development, so there’s a lot of balls in the air and it just depends on a daily basis on what demands attention. I try to spend as much time as I can with the people in the labs because they’re the closest ones to what’s really happening and that’s the fun stuff… and some of the things that drive you completely nuts, too, right? DH: Every day is different—that’s why I love working in research! A typical day for me is one in which I learn something new. That’s the best part of being a scientist. When I was a bench scientist, learning something new, and being the first person to know it, was really exciting. Now, though I’m usually not the first person to know it, learning something new—that’s a good day.
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