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Three Distinct Phases of HIV-1 RNA Decay in Treatment-Naive Patients Receiving Raltegravir-Based Antiretroviral Therapy: ACTG A5248
Journal article   Open access   Peer reviewed

Three Distinct Phases of HIV-1 RNA Decay in Treatment-Naive Patients Receiving Raltegravir-Based Antiretroviral Therapy: ACTG A5248

Adriana Andrade, Susan L. Rosenkranz, Anthony R. Cillo, Darlene Lu, Eric S. Daar, Jeffrey M. Jacobson, Michael Lederman, Edward P. Acosta, Thomas Campbell, Judith Feinberg, …
The Journal of infectious diseases, v 208(6), pp 884-891
24 Jun 2013
PMID: 23801609
url
https://academic.oup.com/jid/article-pdf/208/6/884/18069783/jit272.pdfView
Published, Version of Record (VoR) Open
url
https://doi.org/10.1093/infdis/jit272View
Published, Version of Record (VoR) Open

Abstract

ACTG A5160s ACTG A5166s ACTG A5248 Major and Brief Reports raltegravir Roche ultrasensitive assay single copy assay viral decay
Objective.  The goal of this study was to define viral kinetics after initiation of raltegravir (RAL)–based antiretroviral therapy (ART). Methods.  ART-naive patients received RAL, tenofovir disoproxil fumarate, and emtricitabine for 72 weeks. Human immunodeficiency virus type 1 (HIV-1) RNA were measured by ultrasensitive and single-copy assays, and first ( d 1 )–, second ( d 2 )–, and, third ( d 3 )–phase decay rates were estimated by mixed-effects models. Decay data were compared to historical estimates for efavirenz (EFV)– and ritonavir/lopinavir (LPV/r)–based regimens. Results.  Bi- and tri-exponential models for ultrasensitive assay (n = 38) and single-copy assay (n = 8) data, respectively, provided the best fits over 8 and 72 weeks. The median d 1 with ultrasensitive data was 0.563/day (interquartile range [IQR], 0.501–0.610/day), significantly slower than d 1 for EFV-based regimens [ P < .001]). The median duration of d 1 was 15.1 days, transitioning to d 2 at an HIV-1 RNA of 91 copies/mL, indicating a longer duration of d 1 and a d 2 transition at lower viremia levels than with EFV. Median patient-specific decay estimates with the single-copy assay were 0.607/day (IQR, 0.582–0.653) for d 1 , 0.070/day (IQR, 0.042–0.079) for d 2 , and 0.0016/day (IQR, 0.0005–0.0022) for d 3 ; the median d 1 duration was 16.1 days, transitioning to d 2 at 69 copies/mL. d 3 transition occurred at 110 days, at 2.6 copies/mL, similar to values for LPV/r-based regimens. Conclusions.  Models using single-copy assay data revealed 3 phases of decay with RAL-containing ART, with a longer duration of first-phase decay consistent with RAL-mediated blockade of productive infection from preintegration complexes. Clinical Trials Registration.  NCT00660972.

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Collaboration types
Domestic collaboration
Web of Science research areas
Immunology
Infectious Diseases
Microbiology
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