title: Hepatic safety of efavirenz in HIV/hepatitis C virus-coinfected patients with advanced liver fibrosis.
abstract: OBJECTIVE
  To assess the frequency of severe liver toxicity in HIV/hepatitis C (HCV)-coinfected patients with advanced liver fibrosis receiving efavirenz (EFV)-based antiretroviral combinations.
  
  
  METHODS
  One hundred and eighty-nine previously antiretroviral naïve, HIV/HCV-coinfected patients, who started a regimen including two nucleoside analogues plus EFV, and in whom the presence or absence of advanced liver fibrosis could be established, were retrospectively analyzed. Liver fibrosis was evaluated according to a stepwise algorithm including liver biopsy, transient elastography and FIB-4 index.
  
  
  RESULTS
  Fifty-six patients had advanced fibrosis - 25 with cirrhosis - and 133 did not. Three (5.4%) subjects with and 9 (6.8%) (p=0.717) without advanced fibrosis developed grade 3-4 transaminase elevation (TE). Grade 4 total bilirubin elevation was seen in 5 (8.9%) patients with advanced fibrosis and in 1 (0.8%) without it (p=0.003). Liver events led to EFV discontinuation in 10 (5.3%) patients, 6 (10.7%) with and 4 (3%) without advanced fibrosis (p=0.031).
  
  
  CONCLUSIONS
  The hepatic tolerability of EFV was good in HIV/HCV-coinfected patients with advanced liver fibrosis. The frequency of grade 3-4 TE was similar to that observed in patients without advanced fibrosis, there was no death attributable to liver failure caused by drug toxicity and the rate of EFV discontinuations due to liver events was low.
authors.affiliation: Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Avenida de Bellavista S/N, 41014 Seville, Spain. japineda@telefonica.net
authors.forename: Juan A
authors.initials: JA
authors.lastname: Pineda
authors.forename: Karin
authors.initials: K
authors.lastname: Neukam
authors.forename: Josep
authors.initials: J
authors.lastname: Mallolas
authors.forename: Luis F
authors.initials: LF
authors.lastname: López-Cortés
authors.forename: José A
authors.initials: JA
authors.lastname: Cartón
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.forename: Santiago
authors.initials: S
authors.lastname: Moreno
authors.forename: José A
authors.initials: JA
authors.lastname: Iribarren
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
authors.forename: Manuel
authors.initials: M
authors.lastname: Crespo
authors.forename: Ignacio
authors.initials: I
authors.lastname: de Los Santos
authors.forename: Enrique
authors.initials: E
authors.lastname: Ortega
authors.forename: Hernando
authors.initials: H
authors.lastname: Knobel
authors.forename: María J
authors.initials: MJ
authors.lastname: Jiménez-Expósito
authors.forename: Juan
authors.initials: J
authors.lastname: Macías
mesh_terms: D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D048588:Benzoxazines / Q000009:adverse effects* / Q000627:therapeutic use; D060085:Coinfection; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006526:Hepatitis C / Q000150:complications*; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000473:pathology / Q000821:virology; D008103:Liver Cirrhosis / Q000150:complications / Q000473:pathology; D008297:Male; D008875:Middle Aged
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; C098320:efavirenz