OBJECTIVE: The primary objective of this study was to estimate the incidence of treatment failure (TF) to protease inhibitor monotherapies (PI/r-MT) with lopinavir/ritonavir (LPV/r) or darunavir/ritonavir (DRV/r). DESIGN: A multicenter cohort of HIV-infected patients with viral load (VL) ≤50 copies/mL, who underwent a switch from any triple combination therapy to PI/r-MT with either LPV/r or DRV/r. METHODS: VL was assessed in each center according to local procedures. Residual viremia was defined by any HIV-RNA value detectable below 50 copies/mL by a Real-Time PCR method. Standard survival analysis was used to estimate the rate of TF (defined by virological failure or interruption of monotherapy or reintroduction of combination therapy). A multivariable Cox regression analysis with automatic stepwise procedures was used to identify factors independently associated with TF among nadir and baseline CD4+ counts, residual viremia, time spent with <50 HIV-RNA copies/mL before switch, history of virological failure, HCV co-infection, being on a PI/r and hemoglobin concentrations at baseline. RESULTS: Six hundred ninety patients fulfilled the inclusion criteria and were included in this analysis. Their median follow-up was 20 (10-37) months. By month 36, TF occurred in 176 (30.2%; 95% CI:25.9-34.5) patients. Only CD4+ nadir counts (adjusted hazard ratio [aHR] = 2.03 [95% CI: 1.35, 3.07] for counts ≤100 vs. >100 cells/μL) and residual viremia (aHR = 1.48 [95% CI: 1.01-2.17] vs. undetectable VL) were independently associated to TF. CONCLUSIONS: Residual viremia and nadir CD4+ counts <100 cells/μL should be regarded as the main factors to be taken into account before considering switching to a PI/r-MT.
Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients / N. Gianotti, A. Cozzi-Lepri, A. Antinori, A. Castagna, A. De Luca, B.M. Celesia, M. Galli, C. Mussini, C. Pinnetti, V. Spagnuolo, A. D'Arminio Monforte, F. Ceccherini-Silberstein, M. Andreoni. - In: PLOS ONE. - ISSN 1932-6203. - 12:2(2017 Feb 13), pp. e0171611.1-e0171611.16.
|Titolo:||Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients|
|Parole Chiave:||Adult; Antiretroviral Therapy, Highly Active; CD4 Lymphocyte Count; Cohort Studies; Darunavir; Drug Therapy, Combination; Female; HIV; HIV Infections; HIV Protease Inhibitors; Humans; Kaplan-Meier Estimate; Lopinavir; Male; Middle Aged; Outcome Assessment (Health Care); Proportional Hazards Models; RNA, Viral; Ritonavir; Viral Load; Viremia; Young Adult; Biochemistry, Genetics and Molecular Biology (all); Agricultural and Biological Sciences (all)|
|Settore Scientifico Disciplinare:||Settore MED/17 - Malattie Infettive|
|Data di pubblicazione:||13-feb-2017|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1371/journal.pone.0171611|
|Appare nelle tipologie:||01 - Articolo su periodico|