title: Incidence of and risk factors for severe hepatotoxicity of nelfinavir-containing regimens among HIV-infected patients with chronic hepatitis C.
abstract: OBJECTIVE
  To determine the incidence of and risk factors for severe hepatotoxicity of nelfinavir-containing regimens among human immunodeficiency virus/hepatitis C virus (HIV/HCV)-coinfected patients with known stage of liver fibrosis.
  
  
  METHODS
  All HIV/HCV-coinfected patients were monitored for a period of 12 months after starting nelfinavir-containing regimens and, with an available liver biopsy, were included in a retrospective study.
  
  
  RESULTS
  A total of 82 patients were included in the study. Nine (10.9%) HIV/HCV-coinfected patients showed an episode of severe hepatotoxicity during the study period. Eight (9.8%) individuals showed grade 3 or 4 change in levels of serum alanine aminotransferase and one subject presented with an event of decompensated liver cirrhosis. Six (18.2%) of 33 patients with advanced liver fibrosis and three (6%) of 49 individuals without advanced liver fibrosis showed an episode of severe hepatotoxicity (P = 0.1). In the multivariate analysis, only nevirapine use during nelfinavir therapy [adjusted odds ratio (AOR) 8.9; 95% confidence interval (CI), 1.4-54.1; P = 0.01] was independently associated with risk of development of severe liver toxicity.
  
  
  CONCLUSIONS
  The incidence of severe hepatotoxicity of nelfinavir-containing regimens is low among HIV/HCV-coinfected patients with known stage of liver fibrosis. In addition, our findings show that concomitant nevirapine use is associated with an increased risk of severe hepatotoxicity in these subjects. Likewise, the proportion of severe liver toxicity tended to be higher in individuals with advanced liver fibrosis.
authors.affiliation: Servicio de Medicina Interna, Hospital Universitario de Valme Sevilla, Spain.
authors.forename: José A
authors.initials: JA
authors.lastname: Mira
authors.forename: Juan
authors.initials: J
authors.lastname: Macías
authors.forename: José A
authors.initials: JA
authors.lastname: Girón-González
authors.forename: Dolores
authors.initials: D
authors.lastname: Merino
authors.forename: Mercedes
authors.initials: M
authors.lastname: González-Serrano
authors.forename: Manuel E
authors.initials: ME
authors.lastname: Jiménez-Mejías
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Caballero-Granado
authors.forename: Julián
authors.initials: J
authors.lastname: Torre-Cisneros
authors.forename: Alberto
authors.initials: A
authors.lastname: Terrón
authors.forename: Mark I
authors.initials: MI
authors.lastname: Becker
authors.forename: Jesús
authors.initials: J
authors.lastname: Gómez-Mateos
authors.forename: Ana
authors.initials: A
authors.lastname: Arizcorreta-Yarza
authors.forename: Juan A
authors.initials: JA
authors.lastname: Pineda
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications*; D019698:Hepatitis C, Chronic / Q000150:complications*; D006801:Humans; D015994:Incidence; D008297:Male; D019888:Nelfinavir / Q000009:adverse effects*; D012189:Retrospective Studies; D012307:Risk Factors
chemical_list: D019380:Anti-HIV Agents; D019888:Nelfinavir