Antonio Di Biagio1, Laura Ambra Nicolini1, Patrizia Lorenzini2, Massimo Puoti3, Andrea Antinori2, Alessandro Cozzi-Lepri4, Andrea Gori5, Jacopo Vecchiet6, Cristina Mussini7, Massimo Andreoni8, Claudio Viscoli1, Antonella d'Arminio Monforte9. 1. Clinica Malattie Infettive, IRCCS Azienda Ospedaliera Universitaria San Martino-IST, Genova, Italy. 2. INMI L Spallanzani, Roma, Italy. 3. Malattie Infettive Azienda Ospedaliera Niguarda Ca' Grande, Milano, Italy. 4. UCL Research Department of Infection and Population Health, London, UK. 5. Malattie Infettive Azienda Ospedaliera Universitaria San Gerardo, Monza, Italy. 6. Clinica Malattie Infettive Università di Chieti, Chieti, Italy. 7. Clinica Malattie Infettive Università di Modena, Modena, Italy. 8. Clinica Malattie Infettive Università di Tor Vergata, Roma, Italy. 9. Clinica Malattie Infettive Ospedale San Paolo, Università di Milano, Milano, Italy.
Abstract
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.
OBJECTIVES: To investigate differences in liver enzyme elevation (LEE) between HIV-infectedpatients with and without HCV coinfection who start a darunavir/ritonavir-containing regimen. METHODS:HIV-infectedpatients 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 coinfectedpatients. 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 coinfectedpatients. HCV active coinfectedpatients 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.
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Authors: Karin Neukam; Nuria Espinosa; Antonio Collado; Marcial Delgado-Fernández; Patricia Jiménez-Aguilar; Antonio Rivero-Juárez; Victor Hontañón-Antoñana; Ana Gómez-Berrocal; Josefa Ruiz-Morales; Dolores Merino; Ana Carrero; Francisco Téllez; María José Ríos; José Hernández-Quero; María de Lagarde-Sebastián; Inés Pérez-Camacho; Francisco Vera-Méndez; Juan Macías; Juan A Pineda Journal: PLoS One Date: 2016-05-19 Impact factor: 3.240
Authors: Karin Neukam; José A Mira; Antonio Collado; Antonio Rivero-Juárez; Patricia Monje-Agudo; Josefa Ruiz-Morales; María José Ríos; Dolores Merino; Francisco Téllez; Inés Pérez-Camacho; María Carmen Gálvez-Contreras; Antonio Rivero; Juan A Pineda Journal: PLoS One Date: 2016-02-05 Impact factor: 3.240