Abacavir/lamivudine versus tenofovir DF/emtricitabine as part of combination regimens for initial treatment of HIV: final results.

Abstract

BACKGROUND:

AIDS Clinical Trials Group A5202 compared blinded abacavir/lamivudine (ABC/3TC) to tenofovir DF/emtricitabine (TDF/FTC) with efavirenz (EFV) or atazanavir/ritonavir (ATV/r) in human immunodeficiency virus (HIV)-infected treatment-naive patients, stratified by screening HIV RNA (< or ≥ 10(5) copies/mL). Due to higher virologic failure with ABC/3TC in the high HIV RNA stratum, blinded treatment was stopped in this group, but study follow-up continued for all patients.

METHODS:

Primary endpoints were times to virologic failure, regimen modification, and safety event.

RESULTS:

In the low HIV RNA stratum, time to virologic failure was similar for ABC/3TC vs TDF/FTC with ATV/r (hazard ratio [HR] 1.25, 95% confidence interval [CI] 0.76, 2.05) or EFV (HR 1.23, 95% CI 0.77, 1.96), with significantly shorter times to regimen modification for ABC/3TC with EFV or ATV/r and to safety events with EFV. Prior to stopping blinded treatment in the high stratum, higher virologic failure rates were seen with ABC/3TC with EFV (HR 2.46, 95% CI 1.20, 5.05) or ATV/r (HR 2.22, 95% CI 1.19, 4.14).

CONCLUSIONS:

In the low HIV RNA stratum, times to virologic failure for ABC/3TC or TDF/FTC were not different with EFV or ATV/r. In the high stratum, virologic failure rate was significantly higher for ABC/3TC than for TDF/FTC when given with either EFV or ATV/r.

• Authors: Paul E Sax, Camlin Tierney, Ann C Collier, Eric S Daar, Katie Mollan, Chakra Budhathoki, Catherine Godfrey, Nasreen C Jahed, Laurie Myers, David Katzenstein, Awny Farajallah, James F Rooney, Belinda Ha, William C Woodward, Judith Feinberg, Karen Tashima, Robert L Murphy, Margaret A Fischl, AIDS Clinical Trials Group Study A5202 Team
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 204 Issue 8 Pg. 1191-201 (Oct 15 2011) ISSN: 1537-6613 [Electronic] United States
• PMID: 21917892 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

• Anti-HIV Agents
• Dideoxynucleosides
• Organophosphonates
• RNA, Viral
• Deoxycytidine
• Lamivudine
• Tenofovir
• Emtricitabine
• Adenine
• abacavir

Topics

• Adenine (administration & dosage, analogs & derivatives)
• Adult
• Anti-HIV Agents (administration & dosage)
• Antiretroviral Therapy, Highly Active (methods)
• CD4 Lymphocyte Count
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Dideoxynucleosides (administration & dosage)
• Double-Blind Method
• Emtricitabine
• Female
• HIV (genetics)
• HIV Infections (drug therapy, virology)
• Humans
• Kaplan-Meier Estimate
• Lamivudine (administration & dosage)
• Male
• Middle Aged
• Organophosphonates (administration & dosage)
• RNA, Viral (analysis, blood)
• Tenofovir
• Viral Load