Alcohol Use and Sustained Virologic Response to Hepatitis C Virus Direct-Acting Antiviral Therapy

• Authors: Emily Jeanne Cartwright, Emory University; Chloe Pierret, London School of Hygiene & Tropical Medicine; Caroline Minassian, London School of Hygiene & Tropical Medicine; Denise A Esserman, Veterans Affairs Connecticut Healthcare System; Janet P Tate, Veterans Affairs Connecticut Healthcare System; Matthew B Goetz, University of California, Los Angeles, California; Debika Bhattacharya, University of California, Los Angeles, California; David A Fiellin, Yale University; Amy C Justice, Yale University; Vincent Lo Re, III, University of Pennsylvania; Christopher T Rentsch, London School of Hygiene & Tropical Medicine
• Journal Title: JAMA Network Open
• Volume: Volume 6, Number 9
• Publisher: American Medical Association. | 2023-09-26, Pages e2335715-None
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1001/jamanetworkopen.2023.35715
• Subjects: Health Sciences, Public Health; Health Sciences, Immunology; Health Sciences, Medicine and Surgery
• Keywords: HCV; SVR, sustained virologic response; alcohol use disorder (AUD); direct acting antivirals (DAAs); cohort study

Abstract

Question Is alcohol use associated with achieving a sustained virologic response (SVR) when treating hepatitis C virus (HCV) infection with direct-acting antiviral (DAA) therapy? Findings In this cohort study of 69 229 adults with HCV infection, there was no difference in SVR across alcohol use categories, even for patients with high-risk consumption or alcohol use disorder, after adjusting for potential confounding variables. Meaning These findings suggest that restricting access to DAA therapy on the basis of alcohol use creates an unnecessary barrier for patients and challenges HCV elimination goals. This cohort study evaluates whether alcohol use is associated with achieving a sustained virologic response when treating hepatitis C virus (HCV) infection with direct-acting antiviral therapy. Importance: Some payers and clinicians require alcohol abstinence to receive direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection. Objective To evaluate whether alcohol use at DAA treatment initiation is associated with decreased likelihood of sustained virologic response (SVR). Design, Setting, and Participants This retrospective cohort study used electronic health records from the US Department of Veterans Affairs (VA), the largest integrated national health care system that provides unrestricted access to HCV treatment. Participants included all patients born between 1945 and 1965 who were dispensed DAA therapy between January 1, 2014, and June 30, 2018. Data analysis was completed in November 2020 with updated sensitivity analyses performed in 2023. Exposure Alcohol use categories were generated using responses to the Alcohol Use Disorders Identification Test–Consumption (AUDIT-C) questionnaire and International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnoses for alcohol use disorder (AUD): abstinent without history of AUD, abstinent with history of AUD, lower-risk consumption, moderate-risk consumption, and high-risk consumption or AUD. Main Outcomes and Measures The primary outcome was SVR, which was defined as undetectable HCV RNA for 12 weeks or longer after completion of DAA therapy. Multivariable logistic regression was used to estimate odds ratios (ORs) and 95% CIs of SVR associated with alcohol category. Results Among 69 229 patients who initiated DAA therapy (mean [SD] age, 62.6 [4.5] years; 67 150 men [97.0%]; 34 655 non-Hispanic White individuals [50.1%]; 28 094 non-Hispanic Black individuals [40.6%]; 58 477 individuals [84.5%] with HCV genotype 1), 65 355 (94.4%) achieved SVR. A total of 32 290 individuals (46.6%) were abstinent without AUD, 9192 (13.3%) were abstinent with AUD, 13 415 (19.4%) had lower-risk consumption, 3117 (4.5%) had moderate-risk consumption, and 11 215 (16.2%) had high-risk consumption or AUD. After adjustment for potential confounding variables, there was no difference in SVR across alcohol use categories, even for patients with high-risk consumption or AUD (OR, 0.95; 95% CI, 0.85-1.07). There was no evidence of interaction by stage of hepatic fibrosis measured by fibrosis-4 score (P for interaction = .30). Conclusions and Relevance In this cohort study, alcohol use and AUD were not associated with lower odds of SVR. Restricting access to DAA therapy according to alcohol use creates an unnecessary barrier to patients and challenges HCV elimination goals.