Viro-immunological response of drug-naive HIV-1-infected patients starting a first-line regimen with viraemia >500,000 copies/ml in clinical practice

Maria Mercedes Santoro, Domenico Di Carlo, Daniele Armenia, Mauro Zaccarelli, Carmela Pinnetti, Manuela Colafigli, Francesca Prati, Andrea Boschi, Anna Maria Degli Antoni, Filippo Lagi, Laura Sighinolfi, Cristina Gervasoni, Massimo Andreoni, Andrea Antinori, Cristina Mussini, Carlo Federico Perno, Vanni Borghi, Gaetana Sterrantino

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BACKGROUND: Virological success (VS) and immunological reconstitution (IR) of antiretroviral-naïve HIV-1 infected patients with pre-therapy viral load (VL) >500,000 copies/mL was assessed after 12 months of treatment according to initial drug-class regimens.

METHODS: An observational multicenter retrospective study was performed. VS was defined as the first VL <50 copies/mL from treatment start. IR was defined as an increase of at least 150 CD4+ T-lymphocytes from treatment start. Survival analysis was used to estimate the probability and predictors of VS and IR by 12 months of therapy.

RESULTS: 428 HIV-1 infected patients were analysed. Patients were grouped according to the different first-line drug-classes used: i) a non-nucleoside reverse transcriptase inhibitor (NNRTI) plus two NRTIs (NNRTI-group; N=105 [24.5%]); ii) a protease inhibitor (PI) plus two NRTIs (PI-group; N=260 [60.8%]); iii) a four-drug regimen containing a PI-regimen plus an integrase inhibitor (PI+INI-group; N=63 [14.7%]). ​: Patients in PI-group showed the lowest probability of VS (PI-group: 72.4%; NNRTI-group: 75.5%; PI+INI-group: 81.0%) (p<0.0001). By Cox regression, patients in PI+INI and NNRTI-groups showed a higher adjusted hazard ratio [95%CI] of VS compared to those in PI-group (PI+INI-group: 1.48 [1.08-2.03], p=0.014; NNRTI-group: 1.37 [1.06-1.78], p=0.015). ​: The probability of IR was 76.2%, and was similar among groups. Patients with AIDS showed a lower adjusted hazard ratio [95%CI] of IR compared to non-AIDS presenter (0.70 [0.54-0.90], p=0.005).

CONCLUSIONS: In this multicentre retrospective study, patients with viremia >500,000 copies/mL who start a first-line regimen containing PI+INI or NNRTI yield a better VS compared to those receiving a PI-based regimen.

Original languageEnglish
JournalAntiviral Therapy
Publication statusE-pub ahead of print - Sep 22 2017


  • Journal Article


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