1. 1 Review of Antiretroviral Therapy in Adults HAIVN Harvard Medical School AIDS Initiative in Vietnam

2. 2 Learning Objectives By the end of this session, participants should be able to: Explain the criteria for starting ART Identify the first line ARV regimens Describe the common side effects caused by NRTIs and NNRTIs Describe the protocol for performing routine follow-up with ARV patients

3. 3 Drug Classes of Antiretrovirals (ARV) 1. Nucleoside Reverse Transcriptase Inhibitors (NRTI) 2. Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) 3. Protease Inhibitors (PI) 4. Fusion/Entry Inhibitors 5. Integrase Inhibitors

4. 4 ARV Drugs Currently Available in the World and Vietnam Nucleoside/ Nucleotide RTI AZT / Zidovudine d4T / Stavudine 3TC / Lamivudine ddI / didanosine ABC / Abacavir TDF / Tenofovir FTC / Emtricitabine Non- nucleoside RTI NVP /Nevirapine DLV / Delavirdine EFV / Efavirenz ETR / Etravirine Protease inhibitors SQV / Saquinavir RTV / Ritonavir IDV / Indinavir NFV / Nelfinavir APV / Amprenavir LPVr / Lopinavir + ritonavir ATV / Atazanavir Fos-Amprenavir DRV / Darunavir TPV / Tipranavir Integrase inhibitors RAL / Raltegravir Fusion/Entry inhibitors MVC / Mariviroc ENF / Enfuvirtide

5. 5 Goals of ARV Therapy Inhibit HIV replication As low as possible (undetectable) For as long as possible Allow recovery of the immune system Prevent opportunistic infection Improve survival, health and quality of life

6. 6 When to Start ART? ARV therapy is never an emergency Patients with high CD4 are not at risk for OIs and can delay ARV treatment Decide when to start ARV based on: RisksBenefits Allergy Side Effects Adherence Costs Improve immune function Improve quality of life Decrease risk for OIs

7. 7 When to Start ARV in Vietnam Patients with: CD4 ≤ 350 cells/mm³ irrespective of clinical stage Clinical stage 3 or 4 irrespective of CD4 cell count Modification and Supplement to the Guidelines for Diagnosis and Treatment of HIV/AIDS, MOH November 2011

8. 8 First Line ARV Regimens in Vietnam (1) 2 NRTI + 1 NNRTI Stavudine (D4T) is no longer recommended as a first line ARV Lamivudine (3TC) Tenofovir (TDF) Zidovudine (AZT) Efavirenz (EFV) Nevirapine (NVP) Modification and Supplement to the Guidelines for Diagnosis and Treatment of HIV/AIDS, MOH November 2011

9. 9 First Line ARV Regimens in Vietnam (2) 3TC EFV or NVP + Modification and Supplement to the Guidelines for Diagnosis and Treatment of HIV/AIDS, MOH November 2011 + TDF or AZT

10. 10 First Line ARV Regimens in Vietnam (3) Priority RegimensAlternative Regimens TDF/3TC/EFV TDF/3TC/NVP AZT/3TC/EFV AZT/3TC/NVP Modification and Supplement to the Guidelines for Diagnosis and Treatment of HIV/AIDS, MOH November 2011

11. 11 Side Effects of 1st Line ARVs 11 ClassDrugCommon Side Effects NRTI d4T Peripheral neuropathy Lipoatrophy Lactic acidosis AZT Headache, nausea Anemia TDF Renal Dysfunction NNRTI EFV Rash CNS symptoms Teratogenicity NVP Rash Hepatotoxicity

12. 12 Monitoring Patients on ART

13. 13 Monitoring: How Often? Month 1Month 2Month 3+ Once per weekevery 2 weeks Once per month or every 2 months If the clinical situation is stable:

14. 14 What to Monitor? (1) Adherence Monitoring Assess missed doses Provide counseling about adherence, prevention, and healthy living Clinical Monitoring Weight, temperature WHO Clinical Stage ARV side effects or toxicity Signs of IRIS

15. 15 What to Monitor? (2) Laboratory Monitoring: TestFrequency CBCEvery 6 months Also after 1st month if on AZT ALTEvery 6 months Also after 1st month if on NVP CD4Every 6 months Lipids and Glucose Every year CreatinineEvery 6 months if on TDF

16. 16 Key Points Patients with clinical stage 3 or 4 or CD4 ≤ 350 should start ART Two priority first ARV regimens in Vietnam: TDF + 3TC + EFV TDF + 3TC + NVP All ART patients need routine clinical and laboratory monitoring

17. 17 Thank You! Questions?