title: An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone.
abstract: Extended-release naltrexone (XR-NTX), an approved treatment for opioid or alcohol dependence, is a once-monthly injectable formulation of naltrexone. Hepatotoxicity concerns have limited its use, necessitating further investigation. This study aims to examine hepatic enzyme levels in participants of 2 randomized placebo-controlled trials (RCTs) of XR-NTX. Hepatic transaminases were measured in 85 patients enrolled in RCTs of XR-NTX among HIV-infected prisoners, transitioning to the community and receiving treatment for either dependence on alcohol (52.9%), opioids (44.7%) or both (16.5%). Baseline characteristics included HCV co-infection (55.7%), antiretroviral therapy (81%), mental illness (39%) and receiving psychiatric medications (34.1%). Levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma glutamyl transferase (GGT) were not statistically different between persons randomized to placebo (N=24) and XR-NTX (N=61) arms. These results confirm that XR-NTX is safe to use among opioid and alcohol dependent HIV-infected released prisoners receiving ART with high rates of co-morbid HCV infection and mental illness.
authors.affiliation: Yale School of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT 06510.
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Vagenas
authors.affiliation: Yale School of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT 06510.
authors.forename: Angela
authors.initials: A
authors.lastname: Di Paola
authors.affiliation: Yale School of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT 06510.
authors.forename: Maua
authors.initials: M
authors.lastname: Herme
authors.affiliation: Department of Medicine, Baystate Medical Center, Springfield, MA 01199.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lincoln
authors.affiliation: Department of Medicine, Baystate Medical Center, Springfield, MA 01199.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Skiest
authors.affiliation: Yale School of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT 06510; Yale School of Public Health, Division of Epidemiology of Microbial Diseases, New Haven, CT 06510.
authors.forename: Frederick L
authors.initials: FL
authors.lastname: Altice
authors.affiliation: Yale School of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT 06510. Electronic address: sandra.springer@yale.edu.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Springer
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000437:Alcoholism / Q000150:complications / Q000188:drug therapy*; D001219:Aspartate Aminotransferases / Q000097:blood; D003692:Delayed-Action Preparations; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000201:enzymology; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000201:enzymology; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D009293:Opioid-Related Disorders / Q000150:complications / Q000188:drug therapy*; D011329:Prisoners / Q000706:statistics & numerical data; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase
keywords: Alcohol; Co-morbidities; HIV/AIDS; Hepatotoxicity; Naltrexone; Opioids; Prisoners