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Clinical Trial
. 2013;8(1):e53621.
doi: 10.1371/journal.pone.0053621. Epub 2013 Jan 17.

Role of baseline HIV-1 DNA level in highly-experienced patients receiving raltegravir, etravirine and darunavir/ritonavir regimen (ANRS139 TRIO trial)

Charlotte Charpentier  1 , Catherine Fagard, Céline Colin, Christine Katlama, Jean-Michel Molina, Christine Jacomet, Benoit Visseaux, Anne-Marie Taburet, Françoise Brun-Vézinet, Geneviève Chêne, Yazdan Yazdanpanah, Diane Descamps; ANRS139 TRIO Trial study group
Affiliations
Clinical Trial

Role of baseline HIV-1 DNA level in highly-experienced patients receiving raltegravir, etravirine and darunavir/ritonavir regimen (ANRS139 TRIO trial)

Charlotte Charpentier et al. PLoS One. 2013.

Abstract

Objective: In the ANRS 139 TRIO trial, the use of 3 new active drugs (raltegravir, etravirine, and darunavir/ritonavir), resulted in a potent and sustained inhibition of viral replication in multidrug-resistant treatment-experienced patients. The aim of this virological sub-study of the ANRS 139 TRIO trial was to assess: (i) the evolution of HIV-1 DNA over the first year; and (ii) the association between baseline HIV-1 DNA and virological outcome.

Methods: Among the 103 HIV-1-infected patients included in the ANRS-139 TRIO trial, HIV-1 DNA specimens were available for 92, 84, 88, and 83 patients at Week (W)0, W12, W24, and W48, respectively. Quantification of total HIV-1 DNA was performed by using the commercial kit "Generic HIV DNA Cell" (Biocentric, Bandol, France).

Results: Baseline median HIV-1 DNA of patients displaying virological success (n= 61), viral blip (n= 20), and virological failure (n = 11) were 2.34 log(10) copies/10(6) PBMC (IQR= 2.15-2.66), 2.42 (IQR = 2.12-2.48), and 2.68 (IQR= 2.46-2.83), respectively. Although not statistically significant, patients exhibiting virological success or viral blip had a tendency to display lower baseline HIV-1 DNA than patients experiencing virological failure (P = 0.06). Median decrease of HIV-1 DNA between baseline and W48 was -0.13 log(10) copies/10(6) PBMC (IQR = -0.34 to +0.10), mainly explained by the evolution from W0 to W4. No more changes were observed in the W4-W48 period.

Conclusions: In highly-experienced multidrug-resistant patients, HIV-1 DNA slightly decreased during the first month and then remained stable during the first year of highly potent antiretroviral regimen. In this population, baseline HIV-1 DNA might help to better predict the virological response and to tailor clinical therapeutic management as more aggressive therapeutic choices in patients with higher baseline HIV-1 DNA.

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Conflict of interest statement

Competing Interests: The authors have the following interests. Merck Sharp & Dohme-Chibret provided raltegravir for this study which is marketed by them. Tibotec, a division of Janssen-Cilag, provided etravirine which is marketed by them. There are no further patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

Figures

Figure 1
Figure 1. Longitudinal follow-up of HIV-1 DNA level during the ANRS 139 TRIO Trial.
See this image and copyright information in PMC

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