Longer time to treatment failure and durability of response with efavirenz, zidovudine plus lamivudine: first analysis of full 1266 patient cohort from study 006
Originally Published on September 1, 1999
JO Morales-Ramirez, EW Godofsky, R Stryker, C New man, C Barros Aguado, DR Farina, DJ Manion, NM Ruiz and The Study 006 Investigator Team
ABSTRACT: Background: Data on the first 450 patients in Study 006 have demonstrated superior efficacy and tolerability of efavirenz plus zidovudine plus lamuvidine over indinavir plus zidovudine plus lamivudine.
Methods: Randomized, open-label study of protease inhibitor (PI)-, non-nucleoside reverse transcriptase inhibitor (NNRTI)- and lamuvidine-naïve patients. 83% of the patients were male, 60% were Caucasian and the mean age was 36.5 (±8.7) years. 85% of the individuals were therapy-naïve, the mean HIV-1 RNA was 4/78 log10 copies/mL (60,256 copies/mL) and the mean CD4 count was 341 cells/mm3. Treatment failure was defined as either failure to achieve a viral load of <400 copies/mL by week 24, confirmed viral load rebound >400 copies/mL after successful viral suppression, development of an AIDS-defining even or discontinuation from the study. Duration of HIV suppression (virologic response) was calculated from the time of confirmed response (viral load <400 copies/mL) to failure (confirmed viral load rebound, AIDS-defining event or discontinuation). Only patients who had virological response at any point were included in the analysis.
Results: Of 1266 patients enrolled, 1233 were followed for 24 weeks and 132 for 72 weeks. Time to treatment failure (TTF) was statistically longer in both the efavirenz plus zidovudine plus lamuvidine group than in c control group (P=0.0031). There was no significant difference between the efavirenz plus indinavir group and the control group. With respect to tolerability, 69 patients (16%) in the indinavir plus zidovudine plus lamivudine group discontinued because of an adverse event compared with 27 (6%) in each of the groups, efavirenz plus zidovudine plus lamuvidine efavirenz plus indinavir groups.
Conclusions: The combination of efavirenz plus zidovudine plus lamuvidine was superior to the control regimen of indinavir plus zidovudine plus lamuvidine based on TTF analysis and durability of successful HIV RNA suppression.
