Abstract
ObjectiveIn 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.MethodsAmong 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).ResultsBaseline median HIV-1 DNA of patients displaying virological success (n = 61), viral blip (n = 20), and virological failure (n = 11) were 2.34 log10 copies/106 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 log10 copies/106 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.ConclusionsIn 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.
Highlights
HIV-1 DNA is a major and independent predictor of disease progression in untreated patients with primary or recent HIV infection [1,2]
It has been reported that higher baseline HIV-1 DNA was associated with a higher risk of virological rebound in virologically-controlled patients switching their combined antiretroviral-based regimen to a protease inhibitor (PI) monotherapy with darunavir (ANRS-136 Monoı trial) [3]
A non comparative study, the ‘‘Agence nationale de recherches sur le SIDA et les hepatites virales’’ (ANRS)-139 TRIO trial, showed that a regimen containing three new drugs: the integrase inhibitor raltegravir (RAL), ETR and DRV boosted with ritonavir (DRV/r), resulted in a sustained inhibition of viral replication in multidrug-resistant treatment-experienced patients, with 86% and 88% of patients displaying HIV-1 RNA below 50 copies/mL at one and two years, respectively [4,5]
Summary
HIV-1 DNA is a major and independent predictor of disease progression in untreated patients with primary or recent HIV infection [1,2]. A non comparative study, the ‘‘Agence nationale de recherches sur le SIDA et les hepatites virales’’ (ANRS)-139 TRIO trial, showed that a regimen containing three new drugs: the integrase inhibitor raltegravir (RAL), ETR and DRV boosted with ritonavir (DRV/r), resulted in a sustained inhibition of viral replication in multidrug-resistant treatment-experienced patients, with 86% and 88% of patients displaying HIV-1 RNA below 50 copies/mL at one and two years, respectively [4,5] The aim of this virological sub-study of the 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
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