TY - JOUR
T1 - Abacavir/lamivudine versus tenofovir DF/emtricitabine as part of combination regimens for initial treatment of HIV
T2 - Final results
AU - Sax, Paul E.
AU - Tierney, Camlin
AU - Collier, Ann C.
AU - Daar, Eric S.
AU - Mollan, Katie
AU - Budhathoki, Chakra
AU - Godfrey, Catherine
AU - Jahed, Nasreen C.
AU - Myers, Laurie
AU - Katzenstein, David
AU - Farajallah, Awny
AU - Rooney, James F.
AU - Ha, Belinda
AU - Woodward, William C.
AU - Feinberg, Judith
AU - Tashima, Karen
AU - Murphy, Robert L.
AU - Fischl, Margaret A.
N1 - Funding Information:
Financial support. This work was supported by Award Number U01AI068636 from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), along with the previous grant number for the AIDS Clinical Trials Group (ACTG) Central Group, AI38858, and the Statistical and Data Management Center (SDMC) grant, AI68634. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIAID or the NIH. Also supported in part by the General Clinical Research Center Units funded by the National Center for Research Resources. Abbott Pharmaceuticals, Bristol-Myers Squibb, Gilead Sciences, and GlaxoSmithKline provided the study medications. Potential conflicts of interest. All authors: No reported conflicts.
PY - 2011/10/15
Y1 - 2011/10/15
N2 - 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.
AB - 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.
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U2 - 10.1093/infdis/jir505
DO - 10.1093/infdis/jir505
M3 - Article
C2 - 21917892
AN - SCOPUS:80052897871
VL - 204
SP - 1191
EP - 1201
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
SN - 0022-1899
IS - 8
ER -