Objectives: To investigate differences in liver enzyme elevation (LEE) between HIV-infected patients with and without HCV coinfection who start a darunavir/ritonavir-containing regimen. Methods: HIV-infected patients enrolled in the Italian Cohort of Naïve to Antiretrovirals (ICONA) Foundation Study were included if they started darunavir/ritonavir for the first time. Patients were classified as not HCV coinfected, HCV active coinfected (HCV RNA positive), and HCV nonactive coinfected (HCV-Ab positive/HCV RNA negative). Time to LEE endpoint was defined using the ACTG toxicity scale, based on changes relative to baseline. Kaplan-Meier was used to estimate 1-year and 2-year probability of LEE. The incidence rate ratios (IRRs) of LEEs were estimated until the last follow-up (intention-to-treat analysis [ITT]) and up to darunavir/ritonavir discontinuation (on-treatment analysis [OT]). Results: Overall, 703 patients were included. Ninety-one were HCV-Ab positive; of those, 68 (9.7%) had active HCV coinfection. In 879 person-years of follow-up, 101 LEEs occurred (ITT). No severe hepatotoxicity event was registered in active HCV coinfected patients. HCV active coinfection was predictive of LEE in the overall population (OT: adjusted incidence rate ratio (IRR), 2.25; 95% CI, 0.70-7.24; P = .17; ITT: adjusted IRR, 3.62; 95% CI, 1.67-7.83; P < .001) and in naïve patients (OT: adjusted IRR, 6.29; 95% CI, 2.54-15.55; P = .00; ITT: adjusted IRR, 3.87; 95% CI, 0.99-15.16; P = .05). Conclusions: No grade 3-4 LEEs occurred in HCV active coinfected patients. HCV active coinfected patients experienced low grade LEEs more frequently than HCV-Ab negative patients. Darunavir/ritonavir seems to be safe whatever the HCV status, when liver enzymes are carefully monitored. © 2014 Thomas Land Publishers, Inc.
Di Biagio, A., Nicolini, L., Lorenzini, P., Puoti, M., Antinori, A., Cozzi-Lepri, A., et al. (2014). Liver enzyme elevation during darunavir-based antiretroviral treatment in HIV-1-infected patients with or without hepatitis c coinfection: Data from the ICONA foundation cohort. HIV CLINICAL TRIALS, 15(4), 151-160 [10.1310/hct1504-151].
Citazione: | Di Biagio, A., Nicolini, L., Lorenzini, P., Puoti, M., Antinori, A., Cozzi-Lepri, A., et al. (2014). Liver enzyme elevation during darunavir-based antiretroviral treatment in HIV-1-infected patients with or without hepatitis c coinfection: Data from the ICONA foundation cohort. HIV CLINICAL TRIALS, 15(4), 151-160 [10.1310/hct1504-151]. | |
Tipo: | Articolo in rivista - Articolo scientifico | |
Carattere della pubblicazione: | Scientifica | |
Presenza di un coautore afferente ad Istituzioni straniere: | Si | |
Titolo: | Liver enzyme elevation during darunavir-based antiretroviral treatment in HIV-1-infected patients with or without hepatitis c coinfection: Data from the ICONA foundation cohort | |
Autori: | Di Biagio, A; Nicolini, L; Lorenzini, P; Puoti, M; Antinori, A; Cozzi-Lepri, A; Gori, A; Vecchiet, J; Mussini, C; Andreoni, M; Viscoli, C; D'Arminio Monforte, A | |
Autori: | ||
Data di pubblicazione: | 2014 | |
Lingua: | English | |
Rivista: | HIV CLINICAL TRIALS | |
Digital Object Identifier (DOI): | http://dx.doi.org/10.1310/hct1504-151 | |
Appare nelle tipologie: | 01 - Articolo su rivista |