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Author Notes:

Correspondence to: Jeanette M. Tetrault, M.D., 367 Cedar Street, Suite 305, New Haven, CT 06510, jeanette.tetrault@yale.edu, Phone: (203) 589-1315, Fax (203) 573-6707

The authors would like to acknowledge Shelli Feder, MSN, APRN, FNP-BC, PhD Candidate, Yale School of Nursing who assisted with chart review for this version of the manuscript.

This material is based upon work supported by the Department of Veterans Affairs, Veterans Health Administration, and Office of Research and Development.

For the Veterans Aging Cohort Study Team

We must disclaim that the views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs.


Research Funding:

Supported by: U10 AA013566, U24 AA020794, U01 AA020790, U19 HS021112, R01 HS018372


  • Social Sciences
  • Science & Technology
  • Life Sciences & Biomedicine
  • Psychology, Clinical
  • Substance Abuse
  • Psychology
  • Buprenorphine
  • HIV
  • Hepatitis C
  • Drug induced liver injury
  • RISK

Hepatic Safety of Buprenorphine in HIV-Infected and Uninfected Patients With Opioid Use Disorder: The Role of HCV-Infection

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Journal Title:

Journal of Substance Abuse Treatment


Volume 68


, Pages 62-67

Type of Work:

Article | Post-print: After Peer Review


Introduction: Individuals with HIV and hepatitis C (HCV) infection, alcohol use disorder, or who are prescribed potentially hepatotoxic medications may be at increased risk for buprenorphine (BUP) associated hepatotoxicity. Materials and methods: We examined a cohort of HIV-infected and uninfected patients receiving an initial BUP prescription between 2003 and 2012. We compared changes in alanine and aspartate aminotransferases (ALT and AST) and total bilirubin (TB) stratified by HIV status. We identified cases of liver enzyme elevation (LEE), TB elevation (TBE), and conducted chart review to assess for cases of drug induced liver injury (DILI) and death. We examined associations between age, sex, race, HIV-infection, HCV-infection, alcohol use disorder, and prescription of other potentially heptatotoxic medications with the composite endpoint of LEE, TBE, and DILI. Results: Of 666 patients prescribed BUP, 36% were HIV-infected, 98% were male, 60% had RNA-confirmed HCV infection, 50% had a recent diagnosis of alcohol use disorder, and 64% were prescribed other potentially hepatotoxic medications. No clinically significant changes were observed in median ALT, AST and TB and these changes did not differ between HIV-infected and uninfected patients. Compared with uninfected patients, HIV-infected (OR 7.3, 95% CI 2.1–26.1, p = 0.002), HCV-infected (OR 4.9 95% CI 1.6–15.2, p = 0.007) or HIV/HCV co-infected patients (OR 6.9, 95%CI 2.1–22.2, p = 0.001) were more likely to have the composite endpoint of LEE, TB elevation or DILI, in analyses that excluded 60 patients with evidence of pre-existing liver injury. 31 patients had LEE, 14/187 HIV-infected and 17/340 uninfected (p = 0.25); 11 had TBE, including 9/186 HIV-infected and 2/329 uninfected (p = 0.002); 8 experienced DILI, 4/202 HIV-infected and 4/204 uninfected (p = 0.45). There were no significant associations with alcohol use disorder or prescription of other potentially hepatotoxic medications after adjustment for HIV/HCV status. Conclusions: Liver enzymes and TB are rarely elevated in HIV-infected and uninfected patients receiving BUP. Risk of hepatotoxicity was greater in individuals infected with HIV, HCV, or HIV/HCV co-infection, who may benefit from increased monitoring.

Copyright information:

© 2016 Elsevier Inc.

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