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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of atazanavir, with or without ritonavir, as part of once-daily highly active antiretroviral therapy regimens in antiretroviral-naive patients
Journal of Acquired Immune Deficiency Syndromes, Volume 47, No. 2, Year 2008
Notification
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Description
BACKGROUND: Atazanavir (ATV), the first once-daily protease inhibitor approved for the treatment of HIV-1 infection, is recommended for use in antiretroviral (ARV) treatment-naive and -experienced patients. Study AI424-089 was a prospective, randomized, open-label, 96-week study comparing 2 ATV-based treatment regimens in ARV-naive HIV-infected patients. METHODS: Adults with HIV RNA levels ≥2000 copies/mL were randomized (1:1) to once-daily ATV at a dose of 300 mg with ritonavir at a dose of 100 mg (ATV300/RTV) or ATV at a dose of 400 mg (ATV400); both regimens included lamivudine and an investigational extended-release formulation of stavudine. The primary endpoint for this noninferiority study was the proportion of patients (response rate) with an HIV RNA load <400 copies/mL at week 48. RESULTS: Response rates at week 48 were 86% and 85% on the ATV300/RTV and ATV400 regimens, respectively (difference estimate [95% confidence interval] = 1.5 [-8.2 to 11.1]). There were 3 and 10 patients with virologic failure in the ATV300/RTV and ATV400 groups, respectively. One patient (ATV400) developed phenotypic resistance to ATV associated with an I50L substitution. Adverse event-related discontinuations were 8% among ATV300/RTV-treated patients and <1% among ATV400-treated patients. Plasma lipid elevations were low with both regimens. Both regimens were well tolerated. CONCLUSIONS: These findings demonstrate the safety and efficacy of the ATV300/RTV regimen and confirm the safety and efficacy of ATV400 in an ARV-naive patient population. © 2008 Lippincott Williams & Wilkins, Inc.
Authors & Co-Authors
Malan, Daniel Rudolf
South Africa, Port Elizabeth
Triple M Research, Port Elizabeth
Krantz, Edrich F.
South Africa, Bloemfontein
Quinta-med
David, Neal
South Africa, Cape Town
Brooklyn Medical Centre
Wirtz, Victoria
United States, New York
Bristol-myers Squibb
Hammond, Janet
United States, New York
Bristol-myers Squibb
McGrath, Donnie
United States, New York
Bristol-myers Squibb
Statistics
Citations: 6
Authors: 6
Affiliations: 4
Identifiers
Doi:
10.1097/QAI.0b013e31815ace6a
ISSN:
15254135
Research Areas
Health System And Policy
Infectious Diseases
Study Design
Cross Sectional Study
Cohort Study