11th Conference on Retroviruses and Opportunistic Infections


San Francisco, California - February 8 - 11, 2004

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Efficacy and Safety of Atazanavir with Ritonavir or Saquinavir vs Lopinavir/Ritonavir in Patients Who Have Experienced Virologic Failure on Multiple HAART Regimens: 48-Week Results from BMS A1424-045

Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th:Abstract No. 547

E DeJesus1, B Grinsztejn2, C Rodriguez3, L Nieto-Cisneros4, J Coco5, A Lazzarin6, K Lichtenstein7, M Johnson8, A Rightmire9, S Sankoh10, and R Wilber10
1IDC Res. Initiative, Altamonte Springs, Florida, USA; 2Inst. de Pesquisa Clin. Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil; 3Hosp. Argerich, Buenos Aires, Argentina; 4Hosp. Gabriel Mancera, IMSS Mexico, D.F., Mexico; 5Pendleton Memorial Methodist Hosp., New Orleans, LA, USA; 6S. Raffaele Hosp., Milan, Italy; 7Univ. of Colorado Hlth. Sci. Ctr., Denver, USA; 8Royal Free Hosp., London, UK; 9Bristol-Myers Squibb Co., Hopewell, NJ, USA; and 10Bristol-Myers Squibb Co., Wallingford, CT, USA

BACKGROUND: Atazanavir (ATV) is a potent azapeptide PI with a pharmacokinetic profile allowing for once-daily dosing. ATV trough levels are boosted 5- to 8-fold by ritonavir (RTV) co-administration. The objectives of the study are to compare the efficacy and safety of ATV/RTV and ATV/saquinavir (SQV) to lopinavir (LPV)/RTV as part of combination antiretroviral therapy in highly treatment-experienced HIV-infected patients.

METHODS: Ongoing, prospective, multinational, open-label, 3-arm study in patients who have failed 2 or more HAART regimens containing at least 1 PI, NNRTI, and NRTI, randomized (1:1:1) to ATV/RTV 300/100 mg daily, ATV/SQV 400/1200 mg daily, or LPV/RTV 400/100 mg twice daily, each combined with tenofovir 300 mg daily and 1 NRTI. Parameters assessed include HIV RNA, CD4 cell count, and safety (including lipids).

RESULTS: The following table shows the 48-week results of 358 patients randomized and 347 treated. Median prior PI treatment was 2.5 years.

  ATV/RTV
n = 120		 ATV/SQV
n = 115		 LPV/RTV
n = 123
Baseline Characteristics
AIDS (%) 28 29 30
Median HIV RNA (log10 c/mL) 4.44 4.44 4.47
Median CD4 (cells/mm3) 318 294 289
Efficacy
End Points
Primary		 Mean change, baseline to Week 48 (SE)
HIV RNA (log10 c/mL) -1.93 (0.12) -1.55 (0.14) -1.87 (0.13)
CD4 (cells/mm3) 110 (22.9) 72 (19.7) 121 (20.1)
Time-Averaged
Difference*		 Baseline to Week 48 (97.5% CI)
HIV RNA (log10 c/mL) 0.13 (–0.12, 0.39) 0.33 (0.07, 0.60)  
*compared to LPV/RTV
Lipids Mean % change, baseline to Week 48, Treated Subjects
TC -8 -4 +6†
HDL-C -7 +4 +2
Fasting LDL-C -10 -3 +1
Fasting TG -4 -14 +30†

040208
547

Copyright © 2004 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.