National HIV, AIDS, STI Prevention and Control Program
Job Aids on Dolutegravir Transition November 2020
National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
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CONTENTS
TLD Eligibility ��������������������������������������������������������������������������������������������������������������������������������������� 1 TLD-related Adverse Events ������������������������������������������������������������������������������������������������������������ 2 Common Adverse Effects and its Management �������������������������������������������������������������������������� 3 Managing Immune Reconstitution Inflammatory Syndrome (IRIS) in TLD Patients ������������ 4 Managing Hypersensitivity Reactions in TLD Patients ���������������������������������������������������������������� 5 Managing TLD related Renal and Liver Diseases ������������������������������������������������������������������������ 6 Management and Reporting TLD Adverse Drug Reactions ������������������������������������������������������ 7 TLD Drug-drug Interactions ������������������������������������������������������������������������������������������������������������ 8 TLD and Supplements ���������������������������������������������������������������������������������������������������������������������� 9 Monitoring on TLD ����������������������������������������������������������������������������������������������������������������������������� 10 Role as a Healthcare Worker ������������������������������������������������������������������������������������������������������������ 11 Reporting through Form BC ����������������������������������������������������������������������������������������������������������� 12 References ������������������������������������������������������������������������������������������������������������������������������������������� 13
TLD Eligibility
All adults, adolescents, and children ≥ 30 kg, not on rifampicin-based regimen Not on ART
1. Newly diagnosed OR 2. Lost-to-follow-up returning to care
On ART
First-line ART with severe side effects* AZT or ABC-based regimens with treatment failure
*Eligible side effects ☐ Dizziness ☐ Insomnia ☐ Vivid dreams ☐ Anxiety, depression ☐ Mental confusion ☐ Convulsions ☐ Liver toxicity ☐ Severe skin reactions ☐ Severe hypersensitivity reactions ☐ Gynecomastia
National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
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TLD-related Adverse Events
Commonly reported AEs
Rare but serious AEs
Nausea
Renal toxicity (Fanconi’s syndrome)
Abdominal Pain
Bone problems
Diarrhea
Lipodystrophy
Headache
Lactic acidosis
Itching or mild rash Body ache
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National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
Common Adverse Effects and its Management
Common DTG related adverse effects
Management
Nausea (2-17%)
Drink lots of water
Headache (1-15%)
Paracetamol as needed
Rash (1%)
Antihistamines as needed
Sleep disorder (Insomnia) (1%)
Take TLD upon waking up
Weight gain
Maintain ideal body weight and 150 minute moderate intensity aerobic exercise per week
National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
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Managing Immune Reconstitution Inflammatory Syndrome (IRIS) in TLD Patients
Adverse Event
Description
Management
Immune Reconstitution Inflammatory Syndrome (IRIS)
Happens to someone who is severely immunocompromised and has undetected or incompletely treated preexisting opportunistic infection. Quick recovery of immune system could lead to worsening of symptoms (eg., enlargement of TB adenitis, difficulty of breathing in Pulmonary TB)
It happens as much as with other ART. If unstable vital signs, manage at emergency care level. If stable, can prescribe steroids to decrease inflammation at outpatient.
Pictures from: Meintjes G, Lawn SD, Scano F, et al. Tuberculosis-associated immune reconstitution inflammatory syndrome: case definitions for use in resource-limited settings. Lancet Infect Dis. 2008;8(8):516-523. doi:10.1016/S14733099(08)70184-1
IRIS in a patient with TB adenitis, who presented with enlargement of cervical lymph nodes upon starting ART
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National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
Managing Hypersensitivity Reactions in TLD Patients
Adverse Event
Description
Management
Hypersensitivity Reaction
☐ Severe rash
Stop all drugs until patient recovers. Identify the drug causing severe hypersensitivity as it should never be used again.
— Severe urticaria, angioedema, with or without anaphylaxis ☐ Constitutional symptoms — Fever, malaise, fatigue, etc., AND / OR ☐ Organ dysfunction — Liver and kidney
Picture from: Walkty A, Smith D, Lopko B, Kasper K. Severe skin rash associated with atazanavir. Can J Infect Dis Med Microbiol. 2009;20(1):e10-e12. doi:10.1155/2009/721956
A patient who experienced generalized rash after starting on ART
National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
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Managing TLD related Renal and Liver Diseases Renal Insufficiency
Liver Disease
Common Signs and Symptoms
Decreased urine output, edema, fatigue
Jaundice, RUQ pain, ascites, nausea, vomiting, malaise, disorientation
Dose adjustment
Mild (eGFR 50-80 mL/ min): No dose adjustment
Mild - Moderate (Child Pugh A / B): No dose adjustment
Moderate Severe (eGFR <50 mL/min): Avoid use. Refer to nephrologist
Severe (Child Pugh C): Use with caution but co-manage with gastroenterologist
Child-Pugh Score (Classification of Liver disease severity) 1 point
2 points
3 points
Total bilirubin (umol/L)
<34
34-50
>50
Serum albumin 9g/L)
>35
28-35
<28
PT-INR
<1/7
1.71-2.30
>2.30
Ascites
None
Mild
Mod Severe
Hepatic Encephalopathy
None
Grade I-II Grade (suppressed III-IV (or with refractory) medications)
SCAN ME
Class A: 5-6; Class B: 7-9; Class C: 10-15
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National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
Compute for your patient’s eGFR through here!
Management and Reporting TLD Adverse Drug Reactions
Mild to Moderate
Manage accordingly
Assessment and Management
Tolerated ADR
Continue ART
Impact on Adherence
Severe
Send to emergency
Restart ART
Follow-up and Releases
Interrupted ART intake Substitute ART
SCAN ME
Report to FDA
National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
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TLD Drug-drug Interactions Interaction requiring dose adjustment
☐ Loperamide ☐ Omeprazole ☐ Pain meds: Paracetamol, ibuprofen ☐ Psychiatric: Valproic acid, Lamotrigine, Anti-depressants ☐ Cardiologic: Most antiarrhythmics, Beta blockers, losartan, amlodipine ☐ Antihistamines ☐ Hormonal therapy: Testosterone, ethinyl estradiol ☐ Hormonal contraceptives ☐ Recreational drugs: Alcohol, methamphetamine ☐ Methadone ☐ Anti-malarials ☐ Rifabutin
☐ Rifampicin (such as in HRZE and HR) - DTG 50 mg BID ☐ Antacids - take 2 hours before or 6 hours after TLD ☐ Supplements: Multivitamins, Calcium, and Iron supplements - take 2 hours before or 6 hours after TLD ☐ Metformin - decreases dose of metformin, monitor glycemic control. ☐ St. John’s Wort - may decrease the efficacy of DTG ☐ Carbamezapine - DTG 50mg BID ☐ Etravine - only use with boosted protease inhibitors
Contraindicated ☐ Phenobarbital ☐ Phenytoin
SCAN ME
No interaction / dose adjustment
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National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
TLD and Supplements
Intravenous (IV) Glutathione
IV Glutathione is not approved for skin whitening. It is only approved for use to protect cancer patients from side effects of their chemotherapy. Its use with DTG, as with other ART, has not been established.
Whey protein
Generally safe taken with TLD
Magnesium and Zinc containing supplements
Should NOT be taken together. Take TLD 2 hours before or at least 6 hours after the supplements.
Calcium, Iron, Magnesium, and Aluminum supplements
May be taken with TLD ONLY if with meals. If not taken with meals, take TLD 2 hours before or at least 6 hours after the supplements.
Slimming tea (Senna)
Generally safe taken with TLD
National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
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Monitoring on TLD
History and PE Clinical Status
General well-being and health status, WHO clinical staging
Adherence
Missed pills; investigate if poorly adherent, probe on experience with TLD, treatment motivation, support group, mental health issues, and drug use.
Possible adverse effects
Probe and manage both common and rare adverse drug reactions
Female who has the intent of having a child.
Counsel female patients on the potential risks of TLD intake during early pregnancy. They should be aware there is a risk of neural tube defects 1 in 1000 pregnancies among patients who took TLD before 12 weeks of pregnancy
Laboratory Work-up Effectiveness
Viral load, CD4 count (only in the absence of VL)
Blood chemistries
Serum creatinine (DTG can increase this slightly but not due to renal toxicity) and other routine labs
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National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
Role as a Healthcare Worker
We have important roles* in ensuring the TLD transition is successful Use
Prescribing TLD to the eligible patients
Product/Supplier selection
Counselling patients regarding the transition Inventory Management
Timely and accurate reporting of stocks and other issues
Inventory Management*
Forecasting
Use*
Procurement
Distribution
National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
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Reporting through Form BC BC
HIV CARE REPORT
VISIT INFO
The Law on Reporting Disease (R.A. 3573) & the Philippine AIDS Prevention and Control Act (R.A. 8504) requires physicians to report all diagnosed HIV infections to the HIV & AIDS Registrar at the Epidemiology Bureau, DOH. Please write in CAPITAL LETTERS and CHECK the appropriate boxes.
HIV Confirmatory Code:
Patient code:
Date of visit:
Physician's name:
(MM / DD / YYYY)
Visit type: ☐ First consult at this facility; trans-in from:
☐ Follow-up ☐ Inpatient
Facility name: (HIV treatment facility)
Facility address: Facility contact #:
If this is the patient's first care visit at this facility , please fill out this section: UIC:
Philhealth No.:
__ __ | __ __ | __ __ | __ __ __ __ __ __ __ __
IF FIRST VISIT
* UIC: First two letters of mother's name, first two letters of father's name, two-digit birth order, birthdate (MM-DD-YYYY)
Sex (at birth): ☐ M
Patient's full name: Current residence:
City/Municipality:
KP Class: ☐ MSM
☐ TGP
☐ SW
☐ IDU
☐ Partner of KP
☐ Yes ☐ No
Already on treatment for current active TB prior to this visit?
☐I
LABORATORY TESTS
Latest results
☐ II
☐ III
☐ IV
Date done
Results
Date done copies/mL
Creatinine
μmol/L
CD4 count
cells/µL
HBsAg
IU/mL
Chest X-ray Gene Xpert HIVDR & Genotype
No active TB
TB INFORMATION
Results
Viral load
Presence of at least one of the following: weight loss, cough, night sweats, fever? IPT Status: ☐ Started IPT this visit
☐ Ongoing IPT ☐ Not on IPT
☐ Ended IPT this visit
Site: ☐ Pulmonary Drug resistance:
☐ Completed ☐ ☐ Stopped before target end
OI
☐ Hepatitis B ☐ Hepatitis C
TB tx outcome (if ended this visit):
☐ Pneumocystis pneumonia (PCP) ☐ CMV retinitis ☐ Cotrimoxazole prophylaxis ☐ Azithromycin prophylaxis
Currently pregnant: Type of infant feeding:
☐ No ☐ Yes; Age of gestation: ☐ Breastfeeding ☐ Formula feeding
ART Status:
Drug
☐ Enrolling this visit ☐ Continuing
ART REGIMEN
☐ Extrapulmonary ☐ Susceptible ☐ MDR ☐ RR only ☐ Other: ☐ Not on tx
☐ Other:
Currently taking:
☐ Yes ☐ No
With active TB
TB treatment status: ☐ Ongoing
IPT outcome (if ended IPT this visit):
Infections currently present (check all that apply):
OB
History of PreP: ☐
☐ Yes ☐ No
Already diagnosed with current active TB by another facility?
WHO Classification:
☐F
Province:
☐ XDR
☐ Completed ☐ Other:
☐ Cured ☐ Failed ☐ Not yet evaluated ☐ Other: ☐ Oropharyngeal candidiasis ☐ Others (specify)
If delivered, date of delivery:
☐ Mixed feeding
# of pills per day
# pills missed
(past 30 days)
# of pills left
Date discontinued
Reason (D/C code)
☐ Not on ART Reason if not on ART:
Discontinuation codes: 1- Treatment Failure 2-Clinical progression/hospitalization
HACT Physician approval:
PHARMACY
Date Dispensed
Drug
# of pills on hand
3-Patient Decision/Request 4-Compliance difficulties 5-Drug Interaction
6-Adverse Event (Specify) 7-Others (Specify) 8-Death
# of pills dispensed
Dispensed by:
Please send this accomplished form to Epidemiology Bureau - Department of Health, 2/F Rm. 209, Building 19, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila Contact Nos: (02) 310-1452 & (02) 651-7800 loc. 2952 | EB-DOH Form BC (HIV Care Report) v2017
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National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
TDF+3TC+DTG
References
Health Care Worker Training on the Introduction of Dolutegravir for the Treatment of HIV Infection. New York: ICAP at Columbia University; 2018. Philippines TLD/DTG TRANSITION Operational Plan. Department of Health, Republic of the Philippines; 2020. Meintjes G, Lawn SD, Scano F, et al. Tuberculosis-associated immune reconstitution inflammatory syndrome: case definitions for use in resource-limited settings. Lancet Infect Dis. 2008;8(8):516-523. doi:10.1016/S14733099(08)70184-1. Walkty A, Smith D, Lopko B, Kasper K. Severe skin rash associated with atazanavir. Can J Infect Dis Med Microbiol. 2009;20(1):e10-e12. doi:10.1155/2009/721956.
National HIV, AIDS, STI Prevention and Control Program: Job Aids on Dolutegravir Transition
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