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Daniel R. Kuritzkes, Heather J. Ribaudo, Kathleen E. Squires, Susan L. Koletar, Jorge Santana, Sharon A. Riddler, Richard Reichman, Cecilia Shikuma, William A. Meyer, Karin L. Klingman, Roy M. Gulick, ACTG A5166s Protocol Team, Plasma HIV-1 RNA Dynamics in Antiretroviral-Naive Subjects Receiving either Triple-Nucleoside or Efavirenz-Containing Regimens: ACTG A5166s, The Journal of Infectious Diseases, Volume 195, Issue 8, 15 April 2007, Pages 1169–1176, https://doi.org/10.1086/512619
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Abstract
Objective. We sought to compare clearance rates of plasma human immunodeficiency virus type 1 (HIV-1) RNA in men and women starting triple-nucleoside-based versus efavirenz (EFV)-based regimens.
Methods. First- and second-phase decay rates of plasma HIV-1 were compared in men and women initiating a triple nucleoside reverse-transcriptase inhibitor (NRTI) regimen versus regimens that included EFV plus an NRTI. Subjects (n=64) were randomized to receive zidovudine/lamivudine/abacavir (triple-nucleoside regimen), zidovudine/lamivudine plus EFV (3-drug EFV regimen) or zidovudine/lamivudine/abacavir plus EFV (4-drug EFV regimen). Plasma HIV-1 RNA levels were fitted to a biexponential viral-dynamics model using a nonlinear mixed-effects model. Nonparametric Wilcoxon tests compared empirical Bayes estimates of first- and second-phase viral decay rates between treatment arms and sex.
Results. Median first-phase viral decay rates were significantly faster in subjects receiving the 3-drug EFV regimen (0.67/day), compared with those receiving the triple-nucleoside regimen (0.56/day; P=.02). The second-phase viral decay rate was also faster in the 3-drug EFV group than in the triple-nucleoside group (P=.09). Decay rates in the 4-drug EFV group were intermediate. Viral decay rates were not significantly different in men and women.
Conclusions. Faster initial viral decay in subjects randomized to a 3-drug EFV-based regimen corresponded to the overall superior efficacy of that regimen. Viral decay rates did not differ by sex.