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| |  Atazanavir/Ritonavir Noninferior to Lopinavir/Ritonavir Over 96 Weeks in Treatment-Naïve HIV Patients: Presented at ICAAC/IDSA By Ed Susman WASHINGTON, DC -- October 30, 2008 -- A protease inhibitor-based regimen that includes boosted atazanavir demonstrated noninferiority after 96 weeks of treatment when compared with a boosted-lopinavir regimen in HIV-infected patients, researchers reported here at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and Infectious Diseases Society of America (IDSA) 46th Annual Meeting. "Once-daily atazanavir/ritonavir plus tenofovir and emtricitabine demonstrated durable antiviral efficacy and safety," said Judith Absalon, MD, MPH, Bristol-Myers Squibb, Wallingford, Connecticut, speaking here at a poster presentation on October 26. "This regimen is an appropriate therapeutic option for antiretroviral-naïve, HIV-1-infected patients." Researchers enrolled 883 participants infected with HIV-1 into the open-label CASTLE study, randomising them into 2 arms: atazanavir/ritonavir 300 mg/100 mg once daily plus once-daily tenofovir/emtricitabine 300 mg/200 mg (n = 440) and lopinavir/ritonavir 400 mg/100 mg twice a day (n = 443). After 96 weeks, 74% of the atazanavir patients had achieved and maintained viral suppression to undetectable levels using the 50-copies/mL assay compared with 68% of lopinavir patients, fulfilling the prespecified criteria for noninferiority (P < .05). The finding of noninferiority had been demonstrated at 48 weeks; the present study continues to confirm that finding after 2 years. "Virologic failure rates were low -- around 7% -- and the emergence of resistance was infrequent in both regimens," stated Dr. Absalon. Dr. Absalon also noted that patients receiving the atazanavir treatment had a better lipid profile and showed a more favourable gastrointestinal tolerability than those receiving lopinavir. The study found that lopinavir-based treatment resulted in a nonsignificant numerically greater increase in CD4-positive cell counts at 96 weeks -- 290 cells mm3 -- compared with the patients on the atazanavir-based therapy -- 268 cells/mm3. The subjects in this study were about 35 years of age; approximately 69% were male; more than half of the patients had co-infection with hepatitis B or hepatitis C. Funding for this study was provided by Bristol-Myers Squibb Company. [Presentation title: CASTLE: Atazanavir-Ritonavir vs Lopinavir-Ritonavir in Antiretroviral-Naïve HIV-1 Infected Patients: 96 Week Efficacy & Safety. Abstract H-1250d]
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