title: Hepatic safety and antiretroviral effectiveness in HIV-infected patients receiving naltrexone.
abstract: BACKGROUND
  We sought to determine the impact of naltrexone on hepatic enzymes and HIV biomarkers in HIV-infected patients.
  
  
  METHODS
  We used data from the Veterans Aging Cohort Study-Virtual Cohort, an electronic database of administrative, pharmacy, and laboratory data. We restricted our sample to HIV-infected patients who received an initial oral naltrexone prescription of at least 7 days duration. We examined aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and HIV biomarker (CD4 and HIV RNA) values for the 365 days prior to, during, and for the 365 days post-naltrexone prescription. We also examined cases of liver enzyme elevation (LEE; defined as >5 times baseline ALT or AST or >3.5 times baseline if baseline ALT or AST was >40 IU/l).
  
  
  RESULTS
  Of 114 HIV-infected individuals, 97% were men, 45% white, 57% Hepatitis C co-infected; median age was 49 years; 89% of the sample had a history of alcohol dependence and 32% had opioid dependence. Median duration of naltrexone prescription was 49 (interquartile range 30 to 83) days, representing 9,525 person-days of naltrexone use. Mean ALT and AST levels remained below the upper limit of normal. Two cases of LEE occurred. Mean CD4 count remained stable and mean HIV RNA decreased after naltrexone prescription.
  
  
  CONCLUSIONS
  In HIV-infected patients, oral naltrexone is rarely associated with clinically significant ALT or AST changes and does not have a negative impact on biologic parameters. Therefore, HIV-infected patients with alcohol or opioid dependence can be treated with naltrexone.
authors.affiliation: Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA. jeanette.tetrault@yale.edu
authors.forename: Jeanette M
authors.initials: JM
authors.lastname: Tetrault
authors.forename: Janet P
authors.initials: JP
authors.lastname: Tate
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: McGinnis
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Goulet
authors.forename: Lynn E
authors.initials: LE
authors.lastname: Sullivan
authors.forename: Kendall
authors.initials: K
authors.lastname: Bryant
authors.forename: Amy C
authors.initials: AC
authors.lastname: Justice
authors.forename: David A
authors.initials: DA
authors.lastname: Fiellin
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000437:Alcoholism / Q000150:complications; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D001219:Aspartate Aminotransferases / Q000097:blood; D018791:CD4 Lymphocyte Count; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology*; D015331:Cohort Studies; D016208:Databases, Factual; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy; D006801:Humans; D008099:Liver / Q000201:enzymology; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000009:adverse effects*; D009292:Narcotic Antagonists / Q000009:adverse effects*; D009293:Opioid-Related Disorders / Q000150:complications; D012367:RNA, Viral / Q000097:blood; D014728:Veterans
chemical_list: D009292:Narcotic Antagonists; D012367:RNA, Viral; D009271:Naltrexone; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase