Nieto-Cisneros L, Zala C, Fessel WJ, Gonzalez-Garcia J, Cohen C, McGovern R, Adler E, McLaren C; IAS Conference on HIV Pathogenesis and Treatment (2nd : 2003 : Paris, France).

Antivir Ther. 2003; 8 (Suppl.1): abstract no. 117.

Hospital Regional No. 1 Gabriel Mancera, Del Valle, Mexico

BACKGROUND: ATV is a potent once-daily azapeptide PI with a distinct resistance profile, demonstrated safety and efficacy in naive and experienced patients, and a lipid profile superior to marketed PIs. OBJECTIVE: Compare efficacy, lipid profile and safety of non-boosted ATV with LPV/RTV regimens in ARV-experienced patients with virologic failure on a PI-containing regimen. METHODS: Multinational, open-label, controlled study in ARV-experienced patients randomized (1:1) to ATV 400 mg QD or LPV/RTV 400/100 mg BID with two NRTIs. RESULTS: Three hundred patients randomized, 290 treated. Week 24 results demonstrated significant virological responses for both regimens with a greater decrease in RNA for LPV/RTV vs ATV (mean changes from baseline (SE), HIV RNA (log10 c/ml) -2.11 (0.09), -1.67 (0.08); CD4 (cells/mm3) 121 (14), 94 (13). A post-hoc analysis showed decrease in RNA was comparable between regimens in patients without nucleoside mutations at baseline. Mean lipid changes from baseline (LDL-C, total-C, HDL-C, triglycerides) were lower for ATV (-6%, -2%, +12%, -2%) vs LPV/RTV (+5%, +17%, +18%, +55%). Adverse events (AEs) were comparable between regimens and were consistent with known safety and tolerability profiles of the study drugs. Serious AEs were infrequent. CONCLUSIONS: Significant reductions in HIV RNA and robust increases in CD4 cell counts were observed in this PI-failing, ARV-experienced population. While non-boosted ATV demonstrated less antiviral efficacy than the boosted LPV/RTV regimen, ATV had a more favourable lipid profile. ATV may be an option for some ARV-experienced patients, e.g., where lipid management is a priority.

Publication Types:

• Meeting Abstracts

Keywords:

• Anti-HIV Agents
• Antiviral Agents
• CD4 Lymphocyte Count
• Cell Cycle Proteins
• Clinical Protocols
• HIV
• HIV Infections
• HIV Protease Inhibitors
• Humans
• NBN protein, human
• Nuclear Proteins
• Oligopeptides
• Pyridines
• Pyrimidinones
• Reverse Transcriptase Inhibitors
• Ritonavir
• atazanavir
• lopinavir
• virology

Other ID:

• GWAIDS0022804

UI: 102262428

From Meeting Abstracts