Sixth International Congress Drug Therapy in HIV Infection 17-21 November, 2002 Glasgow, UK

Lopinavir (LPV), an HIV protease inhibitor, is co-formulated with ritonavir (r), which inhibits cytochrome p450 3A4, providing increased plasma levels of LPV. Long-term clinical trials of LPV/r in HIV-infected pts are ongoing.

100 ARV-naïve pts were treated with LPV/r + d4T/3TC. Viral load (VL) was measured using a ≤3 c/mL assay at weeks 24/48/72 and at <400 or <50 c/mL at each visit. The time to virologic rebound (consecutive VLs >400 c/mL after VL <400 c/mL or failure to achieve VL <400 c/mL) through year 4 (week 204) was compared between patients who did (n=54) or did not (n=42) achieve VL ≤3 copies/mL at least once. 4 pts discontinued prior to week 24 and had no measurements with the ≤3 c/mL assay.

At year 4, 70/100 (70%) enrolled pts had VL <50 c/mL (intent-to-treat, missing values=failure). 0 of 7 pts with VL rebound through year 4 and available genotype demonstrated PI resistance, and 3/7 demonstrated 3TC resistance. The proportions of pts without virologic rebound through year 4 by Kaplan-Meier analysis were 86% and 83% (p=0.71, log-rank test) for pts who did and did not, respectively, achieve VL ≤3 copies/mL. Virologic failure rates in years 0-1, 1-2, 2-3, and 3-4 were 7.4%, 4.1%, 2.3%, and 0% for pts who achieved VL ≤3 c/mL and 11.9%, 2.4%, 2.5%, and 0% for pts who did not. Response was also independent of baseline VL and CD4 cell count. Notably, 7/14 pts who met virologic rebound criteria remained on study without change in regimen through year 4; all 7 had VL <50 c/mL at year 4.

Patients who did not achieve VL ≤3 copies/mL in the first 72 weeks were not at greater risk of virologic failure through 4 years of LPV/r-based therapy. Response was also independent of baseline VL and CD4 cell count.

Presenting author: Martin King

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1 Abbott Laboratories, Abbott Park, USA.

2 University of Geneva, Switzerland.

2002-11-17
PL3-3

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