Journal Article

Abacavir versus Zidovudine Combined with Lamivudine and Efavirenz, for the Treatment of Antiretroviral-Naive HIV-Infected Adults

Edwin DeJesus, Gisela Herrera, Eugenio Teofilo, Jan Gerstoft, Carlos Beltran Buendia, J. David Brand, Cynthia H. Brothers, Jaime Hernandez, Steve A. Castillo, Tab Bonny, E. Randall Lanier and Trevor R. Scott

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 39, issue 7, pages 1038-1046
Published in print October 2004 | ISSN: 1058-4838
Published online October 2004 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/424009
Abacavir versus Zidovudine Combined with Lamivudine and Efavirenz, for the Treatment of Antiretroviral-Naive HIV-Infected Adults

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Background. Zidovudine, lamivudine, and efavirenz comprise a highly effective and well-tolerated triple regimen for antiretroviral-naive patients. Evaluating other unique nucleoside reverse-transcriptase inhibitor (NRTI) combinations for long-term viral suppression is desirable.

Methods. This multicenter, randomized, double-blind noninferiority clinical trial compared the efficacy and safety of abacavir with that of zidovudine plus lamivudine and efavirenz in 649 antiretroviral-naive HIV-infected patients. The primary objective was a comparison of proportions of patients achieving plasma HIV-1 RNA levels ⩽50 copies/mL through week 48 of the study.

Results. At study week 48, 70% of patients in the abacavir group, compared with 69% in the zidovudine group, maintained confirmed plasma HIV-1 RNA levels of ⩽50 copies/mL (in the intent-to-treat exposed population). Virologic failure was infrequent (6% in the abacavir group and 4% in the zidovudine group). There was a significant CD4+ cell response (209 cells/mm3 in the abacavir group and 155 cells/mm3 in the zidovudine group). Safety profiles were as expected.

Conclusion. Abacavir provided an effective and durable antiretroviral response that was noninferior to zidovudine, when combined with lamivudine and efavirenz.

Journal Article.  4562 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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