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

Antonio Di Biagio, Laura Nicolini, Patrizia Lorenzini, Massimo Puoti, Andrea Antinori, Alessandro Cozzi-Lepri, Andrea Gori, Jacopo Vecchiet, Cristina Mussini, Massimo Andreoni, Claudio Viscoli, Antonella D'Arminio Monforte

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)151-160
Number of pages10
JournalHIV Clinical Trials
Volume15
Issue number4
DOIs
Publication statusPublished - Jan 1 2014

Keywords

  • darunavir
  • hepatitis C virus
  • hepatotoxicity
  • HIV
  • liver enzyme elevations
  • ritonavir

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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    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. (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. https://doi.org/10.1310/hct1504-151