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

Final results

Paul E. Sax, Camlin Tierney, Ann C. Collier, Eric S. Daar, Katie Mollan, Chakra B. 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

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1191-1201
Number of pages11
JournalJournal of Infectious Diseases
Volume204
Issue number8
DOIs
StatePublished - Oct 15 2011
Externally publishedYes

Fingerprint

Tenofovir
efavirenz
Lamivudine
Ritonavir
HIV
RNA
Confidence Intervals
Therapeutics
Safety
lamivudine drug combination abacavir
Emtricitabine
Atazanavir Sulfate

ASJC Scopus subject areas

  • Infectious Diseases
  • Immunology and Allergy

Cite this

Abacavir/lamivudine versus tenofovir DF/emtricitabine as part of combination regimens for initial treatment of HIV : Final results. / Sax, Paul E.; Tierney, Camlin; Collier, Ann C.; Daar, Eric S.; Mollan, Katie; Budhathoki, Chakra B.; Godfrey, Catherine; Jahed, Nasreen C.; Myers, Laurie; Katzenstein, David; Farajallah, Awny; Rooney, James F.; Ha, Belinda; Woodward, William C.; Feinberg, Judith; Tashima, Karen; Murphy, Robert L.; Fischl, Margaret A.

In: Journal of Infectious Diseases, Vol. 204, No. 8, 15.10.2011, p. 1191-1201.

Research output: Contribution to journalArticle

Sax, PE, Tierney, C, Collier, AC, Daar, ES, Mollan, K, Budhathoki, CB, Godfrey, C, Jahed, NC, Myers, L, Katzenstein, D, Farajallah, A, Rooney, JF, Ha, B, Woodward, WC, Feinberg, J, Tashima, K, Murphy, RL & Fischl, MA 2011, 'Abacavir/lamivudine versus tenofovir DF/emtricitabine as part of combination regimens for initial treatment of HIV: Final results', Journal of Infectious Diseases, vol. 204, no. 8, pp. 1191-1201. https://doi.org/10.1093/infdis/jir505
Sax, Paul E. ; Tierney, Camlin ; Collier, Ann C. ; Daar, Eric S. ; Mollan, Katie ; Budhathoki, Chakra B. ; Godfrey, Catherine ; Jahed, Nasreen C. ; Myers, Laurie ; Katzenstein, David ; Farajallah, Awny ; Rooney, James F. ; Ha, Belinda ; Woodward, William C. ; Feinberg, Judith ; Tashima, Karen ; Murphy, Robert L. ; Fischl, Margaret A. / Abacavir/lamivudine versus tenofovir DF/emtricitabine as part of combination regimens for initial treatment of HIV : Final results. In: Journal of Infectious Diseases. 2011 ; Vol. 204, No. 8. pp. 1191-1201.
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title = "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 (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.",
author = "Sax, {Paul E.} and Camlin Tierney and Collier, {Ann C.} and Daar, {Eric S.} and Katie Mollan and Budhathoki, {Chakra B.} and Catherine Godfrey and Jahed, {Nasreen C.} and Laurie Myers and David Katzenstein and Awny Farajallah and Rooney, {James F.} and Belinda Ha and Woodward, {William C.} and Judith Feinberg and Karen Tashima and Murphy, {Robert L.} and Fischl, {Margaret A.}",
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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 B.

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.

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 (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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