Nevirapine/zidovudine/lamivudine has superior immunological and virological responses not reflected in clinical outcomes in a 48-week randomized comparison with abacavir/zidovudine/lamivudine in HIV-infected Ugandan adults with low CD4 cell counts.

HIV Medicine
P MunderiDART/NORA trial teams

Abstract

Triple nucleoside reverse transcriptase inhibitor regimens have advantages as first-line antiretroviral therapy (ART), avoiding hepatotoxicity and interactions with anti-tuberculosis therapy, and sparing two drug classes for second-line ART. Concerns exist about virological potency; efficacy has not been assessed in Africa. A safety trial comparing nevirapine with abacavir was conducted in two Ugandan Development of Antiretroviral Therapy in Africa (DART) centres: 600 symptomatic antiretroviral-naïve HIV-infected adults with CD4 counts <200 cells/microL were randomized to zidovudine/lamivudine plus abacavir or nevirapine (placebo-controlled to 24-week primary toxicity endpoint, and then open-label). Documented World Health Organization (WHO) stage 4 events were independently reviewed and plasma HIV-1 RNA assayed retrospectively. Exploratory efficacy analyses are intention-to-treat. The median pre-ART CD4 count was 99 cells/microL, and the median pre-ART viral load was 284 600 HIV-1 RNA copies/mL. A total of 563 participants (94%) completed 48 weeks of follow-up, 25 (4%) died and 12 (2%) were lost to follow-up. The randomized drug was substituted in 21 participants (7%) receiving abacavir vs. 34 (11%) receiving nevirapine (P=0.0...Continue Reading

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Citations

Jul 20, 2011·Antimicrobial Agents and Chemotherapy·D T DunnUNKNOWN DART Virology and Trial Team
May 7, 2013·PloS One·Alan WinstonUNKNOWN PIVOT Trial Team
Dec 20, 2013·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Ravindra K GuptaUNKNOWN DART Virology Group and Trial Team
Mar 19, 2014·The Journal of Antimicrobial Chemotherapy·R L GoodallUNKNOWN DART Virology Group and Trial Teams
Dec 14, 2011·Expert Opinion on Pharmacotherapy·Maxwell O AkanbiRobert L Murphy
Apr 17, 2012·International Journal of Hepatology·Manuela G NeumanCharles Parry
Apr 26, 2016·Oral Diseases·G Narendran, S Swaminathan
Oct 7, 2016·AIDS Research and Therapy·Narendran GopalanSrikanth Tripathy
Jun 7, 2013·The Cochrane Database of Systematic Reviews·Mario CrucianiOliviero Bosco
Dec 15, 2015·PloS One·Nicole Hassoun
Apr 2, 2013·The Cochrane Database of Systematic Reviews·Muki S SheyCharles Shey Wiysonge

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