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Session 80 Poster Abstracts
Antiretroviral Therapy: Predictors of Response and Virologic Failure
Monday, 1:30 - 3:30 pm
Poster Hall


547
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
E DeJesus1, B Grinsztejn2, C Rodriguez3, L Nieto-Cisneros4, J Coco5, A Lazzarin6, K Lichtenstein7, M Johnson*8, 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†

Keywords: HIV Protease Inhibitors; Comparative Study; Lipids