Journal article
Abacavir-Lamivudine versus Tenofovir-Emtricitabine for Initial HIV-1 Therapy
The New England journal of medicine, Vol.361(23), pp.2230-2240
2009
DOI: 10.1056/NEJMoa0906768
PMCID: PMC2800041
PMID: 19952143
Abstract
BACKGROUND
The use of fixed-dose combination nucleoside reverse-transcriptase inhibitors (NRTIs) with a nonnucleoside reverse-transcriptase inhibitor or a ritonavir-boosted protease inhibitor is recommended as initial therapy in patients with human immunodeficiency virus type 1 (HIV-1) infection, but which NRTI combination has greater efficacy and safety is not known.
METHODS
In a randomized, blinded equivalence study involving 1858 eligible patients, we compared four once-daily antiretroviral regimens as initial therapy for HIV-1 infection: abacavir–lamivudine or tenofovir disoproxil fumarate (DF)–emtricitabine plus efavirenz or ritonavir-boosted atazanavir. The primary efficacy end point was the time from randomization to virologic failure (defined as a confirmed HIV-1 RNA level ≥1000 copies per milliliter at or after 16 weeks and before 24 weeks, or ≥200 copies per milliliter at or after 24 weeks).
RESULTS
A scheduled interim review by an independent data and safety monitoring board showed significant differences in virologic efficacy, according to the NRTI combination, among patients with screening HIV-1 RNA levels of 100,000 copies per milliliter or more. At a median follow-up of 60 weeks, among the 797 patients with screening HIV-1 RNA levels of 100,000 copies per milliliter or more, the time to virologic failure was significantly shorter in the abacavir–lamivudine group than in the tenofovir DF–emtricitabine group (hazard ratio, 2.33; 95% confidence interval, 1.46 to 3.72; P<0.001), with 57 virologic failures (14%) in the abacavir–lamivudine group versus 26 (7%) in the tenofovir DF–emtricitabine group. The time to the first adverse event was also shorter in the abacavir–lamivudine group (P<0.001). There was no significant difference between the study groups in the change from the baseline CD4 cell count at week 48.
CONCLUSIONS
In patients with screening HIV-1 RNA levels of 100,000 copies per milliliter or more, the times to virologic failure and the first adverse event were both significantly shorter in patients randomly assigned to abacavir–lamivudine than in those assigned to tenofovir DF–emtricitabine.
Details
- Title: Subtitle
- Abacavir-Lamivudine versus Tenofovir-Emtricitabine for Initial HIV-1 Therapy
- Creators
- Paul E SAX - Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, BOSTON, United StatesCamlin TIERNEY - Harvard School of Public Health, Boston, United StatesAwny FARAJALLAH - Bristol-Myers Squibb, Plainsboro, NJ, United StatesJames F ROONEY - Gilead Sciences, Foster City, United StatesBelinda HA - GlaxoSmith Kline, Research Triangle Park, NC, United StatesWilliam C WOODWARD - Abbott Laboratories, Abbott Park, IL, United StatesSusan L KOLETAR - Ohio State University, Columbus, United StatesVictoria A JOHNSON - Birmingham Veterans Affairs Medical Center and University ofAlabama School of Medicine at Birmingham, Birmingham, United StatesP. Jan GEISELER - University of Southern California, Los Angeles, United StatesEric S DAAR - Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the University of California, Los Angeles CALIFORNIA, United StatesAnn C COLLIER - University of Washington and Harborview Medical Center, Seattle, United StatesMargaret A FISCHL - University of Miami School of Medicine, Miami, United StatesKatie MOLLAN - Harvard School of Public Health, Boston, United StatesLynne PEEPLES - Harvard School of Public Health, Boston, United StatesCatherine GODFREY - Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, United StatesNasreen C JAHED - Social and Scientific Systems, Silver Spring, Maryland, United StatesLaurie MYERS - Frontier Science and Technology Research Foundation, Amherst, NY, United StatesDavid KATZENSTEIN - Stanford University, Palo Alto, United StatesAIDS Clinical Trials Group Study A5202 Team
- Contributors
- Jeffery L Meier (Contributor) - University of Iowa, Internal MedicineJack T Stapleton (Contributor) - University of Iowa, Internal Medicine
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.361(23), pp.2230-2240
- Publisher
- Massachusetts Medical Society
- DOI
- 10.1056/NEJMoa0906768
- PMID
- 19952143
- PMCID
- PMC2800041
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Language
- English
- Date published
- 2009
- Academic Unit
- Microbiology and Immunology; Infectious Diseases; Epidemiology; Internal Medicine
- Record Identifier
- 9984094554802771
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