title: Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV infection.
abstract: OBJECTIVE
  Naltrexone (Revia, Vivitrol) is recognized as having the potential for hepatotoxicity. We evaluated the safety of intramuscular extended-release naltrexone (XR-NTX) in a cohort of patients with a high prevalence of chronic hepatitis C virus (HC V) and HIV infection undergoing treatment for opioid dependence.
  
  
  METHODS
  A total of 250 (88% male) opioid-dependent patients were randomized to receive monthly injections of XR-NTX 380 mg or placebo. Of the 250 subjects, 222 (88.8%) had a history of HCV; 42% were positive for HIV. Liver chemistry tests for aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, gamma-glutamyl aminotransferase (GGT), alkaline phosphatase, serum albumin, and total protein were obtained at the screening visit, at baseline, and monthly for up to 6 months.
  
  
  RESULTS
  In a longitudinal analysis, the frequency of elevations in AST, ALT, and GGT greater than three times the upper limit of normal (ULN) was not statistically different in patients treated with XR-NTX compared with placebo (p = .71). Most of the elevations greater than three times the ULN occurred in patients with chronic HCV infection. In patients who had a treatment-emergent elevation in AST or ALT greater than three times the ULN, the aminotransferases improved and returned toward baseline in those patients with available follow-up data. No specific symptoms were associated with any of the elevations in ALT, AST, or GGT. The frequency of elevations in AST and ALT during treatment in patients with HIV infection was not significantly different compared with that in patients without HIV infection.
  
  
  CONCLUSIONS
  XR-NTX can be used safely in eligible patients with opioid dependence, including those with underlying mild to moderate chronic HCV and/or HIV infections.
authors.affiliation: Division of Gastroenterology, Johns Hopkins Bayview Medical Center, Baltimore, Maryland. mack.mitchell@utsouthwestern.edu
authors.forename: Mack C
authors.initials: MC
authors.lastname: Mitchell
authors.forename: Asli
authors.initials: A
authors.lastname: Memisoglu
authors.forename: Bernard L
authors.initials: BL
authors.lastname: Silverman
mesh_terms: D000328:Adult; D003692:Delayed-Action Preparations / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007273:Injections, Intramuscular; D008111:Liver Function Tests / Q000379:methods / Q000706:statistics & numerical data*; D008297:Male; D009271:Naltrexone / Q000008:administration & dosage / Q000009:adverse effects*; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000009:adverse effects*; D009293:Opioid-Related Disorders / Q000188:drug therapy*
chemical_list: D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone