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Bristol-Myers Squibb Media Statement on ACTG 5202
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We are pleased with the AIDS Clinical Trials Group (ACTG) data presented today from the Phase IIIb clinical trial ACTG 5202 comparing SUSTIVA® (efavirenz), REYATAZ® (atazanavir sulfate)/ritonavir (REYATAZ/r) each in combination with a nucleoside reverse transcriptase inhibitor (NRTI) backbone, of either abacavir/lamivudine (ABC/3TC) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). The primary efficacy analysis of these data showed that the time to virologic failure was similar between these SUSTIVA and REYATAZ/r arms but did not meet pre-specified equivalence criteria. Although SUSTIVA with ABC/3TC had a significantly shorter time to safety (P = 0.05) and tolerability (P = 0.0008) protocol specified endpoints compared to REYATAZ/r with ABC/3TC, both SUSTIVA and REYATAZ/r with TDF/FTC had similar time to safety and tolerability endpoints.
The results of ACTG 5202 helped to further support SUSTIVA or REYATAZ in combination therapy as an initial therapeutic option for treatment-naive HIV-1 infected patients. Both SUSTIVA and REYATAZ have well-established efficacy, safety and tolerability profiles. REYATAZ/r and SUSTIVA are each recommended in the current U.S. Department of Health and Human Services (DHHS) treatment guidelines as agents for use in preferred regimens for initial therapy in the treatment of HIV-1 infected patients.1
References
1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Department of Health and Human Services. December 1, 2009; 1-161. Available at http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf. Accessed January 27, 2010.
2. Daar E, Tierney C, et al. ACTG 5202: Final results of ABC/3TC or TDF/FTC with either EFV or ATV/r in treatment-naive HIV-infected patients.17th conference on Retroviruses and Opportunistic Infections. February 16-19, 2010, San Francisco, CA. Abstract 59 LB.
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