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

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.

Background: Virological success (VS) and immuno-a PI-regimen plus an integrase inhibitor (PI+INI-group; logical reconstitution (IR) of antiretroviral-naive HIV-n=63 [14.7%]). 1-infected patients with pre-therapy viral load (VL) Patients in the PI-group showed the lowest probability >500,000 copies/ml was assessed after 12 months of of VS (PI-group: 72.4%; NNRTI-group: 75.5%; PI+INI-treatment according to initial drug-class regimens. group: 81.0%; P<0.0001). By Cox regression, patients in Methods: An observational multicentre retrospective PI+INI and NNRTI-groups showed a higher adjusted haz-study was performed. VS was defined as the first VL <50 ard ratio (95% CI) of VS compared to those in the PI-copies/ml from treatment start. IR was defined as an group (PI+INI-group: 1.48 [1.08, 2.03]; P=0.014; NNRTI-increase of at least 150 CD4+ T-lymphocytes from treat-group: 1.37 [1.06-1.78]; P=0.015). ment start. Survival analysis was used to estimate the The probability of IR was 76.2%, and was similar among probability and predictors of VS and IR by 12 months of groups. Patients with AIDS showed a lower adjusted haz-therapy. ard ratio (95% CI) of IR compared to non-AIDS presenters Results: 428 HIV-1-infected patients were analysed. (0.70 [0.54, 0.90]; P=0.005). Patients were grouped according to the different first-Conclusions: In this multicentre retrospective study, line drug-classes used: a non-nucleoside reverse tran-patients with viraemia >500,000 copies/ml who start scriptase inhibitor (NNRTI) plus two nucleoside reverse a first-line regimen containing PI+INI or NNRTI yield transcriptase inhibitors (NRTIs; NNRTI-group; n=105 a better VS compared to those receiving a PI-based [24.5%]); a protease inhibitor (PI) plus two NRTIs (PI-regimen. group; n=260 [60.8%]); a four-drug regimen containing a PI-regimen plus an integrase inhibitor (PI+INI-group; n=63 [14.7%]). Patients in the PI-group showed the lowest probability of VS (PI-group: 72.4%; NNRTI-group: 75.5%; PI+INIgroup: 81.0%; P0.0001). By Cox regression, patients in PI+INI and NNRTI-groups showed a higher adjusted hazard ratio (95% CI) of VS compared to those in the PIgroup (PI+INI-group: 1.48 [1.08, 2.03]; P=0.014; NNRTIgroup: 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 presenters (0.70 [0.54, 0.90]; P=0.005). Conclusions: In this multicentre retrospective study, patients with viraemia >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.