[118] EFFICACY AND SAFETY OF ATAZANAVIR (ATV) WITH RITONAVIR (RTV) OR SAQUINAVIR (SQV) VS LOPINAVIR/RITONAIR (LPV/RTV) IN COMBINATION WITH TENOFOVIR (TFV) AND ONE NRTI IN PATIENTS WHO HAVE EXPERIENCED VIROLOGIC FAILURE TO MULTIPLE HAART REGIMENS: 16-WEEK RESULTS FROM BMS AI424-045

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] EFFICACY AND SAFETY OF ATAZANAVIR (ATV) WITH RITONAVIR (RTV) OR SAQUINAVIR (SQV) VS LOPINAVIR/RITONAIR (LPV/RTV) IN COMBINATION WITH TENOFOVIR (TFV) AND ONE NRTI IN PATIENTS WHO HAVE EXPERIENCED VIROLOGIC FAILURE TO MULTIPLE HAART REGIMENS: 16-WEEK RESULTS FROM BMS AI424-045

[AUTHOR(S):] R. Badaro¹, E. DeJesus², A. Lazzarin³, J. Jemsek⁴, B. Clotet⁵, R. Wilber⁶, A. Thiry⁶, A. Rightmire⁶
¹Hospital Universitario Prof. Edgard Santos, Salvador, Brazil, ²IDC Research Initiative, Altamonte Springs, Florida, ³Fondazione Centro S. Raffaele Del Monte Tabor, Milano, Italy, ⁴Jemsek Clinic, Huntersville, North Carolina, ⁵Hospital Universitari Germans Trias i Pujol, Badalona, Spain, ⁶Bristol-Myers Squibb Company, Wallingford, Connecticut

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 118

[ABSTRACT:] Background: ATV is a potent once-daily azapeptide PI with a distinct resistance profile, demonstrated safety and efficacy in naïve and experienced patients; and a lipid profile superior to marketed PIs. ATV Cmin levels are boosted 5-8 fold by co-administration of RTV.

Objective: Compare the efficacy and safety of ATV/RTV and ATV/SQV to LPV/RTV in patients who have failed multiple HAART regimens.

Methods: Ongoing, multinational, open-label, three-arm study in HAART failure patients randomized (1:1:1) to ATV (300 mg)/RTV (100 mg) QD, ATV (400 mg)/SQV (1200 mg) QD, or LPV (400 mg)/RTV (100 mg) BID, each combined with TFV (300 mg) and one NRTI.

Results: Three hundred fifty-eight patients randomized; 347 treated. At week 16 similar efficacy was observed between ATV/RTV and LPV/RTV, with ATV/SQV having lower efficacy vs LPV/RTV (mean changes from baseline, HIV RNA (log₁₀ c/mL) -1.85, -1.61, -2.00; CD4 (cells/mm³) 84, 55, 110; proportion of patients with HIV RNA<400 c/mL, 64%, 48%, 65%). Mean total cholesterol and triglyceride changes from baseline were favorable for both ATV regimens vs LPV/RTV (cholesterol: -7%, -10%, +5%; triglyceride: +2%, -15%, +34%, respectively). Adverse events (AEs) were comparable among all regimens and were consistent with known safety profiles of study drugs. Serious AEs were infrequent.

Conclusions: In this highly ARV-experienced population, the efficacy of ATV/RTV QD is similar to LPV/RTV BID through 16 weeks. ATV, when boosted with RTV or combined with SQV is safe, well tolerated and with a more favorable lipid profile than LPV/RTV.

Power Point Presentation

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