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. 2023 Sep 5;6(9):e2335715.
doi: 10.1001/jamanetworkopen.2023.35715.

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

Emily J Cartwright  1   2 , Chloe Pierret  3 , Caroline Minassian  3 , Denise A Esserman  4 , Janet P Tate  4   5 , Matthew B Goetz  6   7 , Debika Bhattacharya  6   7 , David A Fiellin  5   8   9 , Amy C Justice  4   5   8   9 , Vincent Lo Re 3rd  10 , Christopher T Rentsch  3   4   5
Affiliations

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

Emily J Cartwright et al. JAMA Netw Open. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Bhattacharya reported receiving grants from Gilead Sciences outside the submitted work. Dr Lo Re III reported receiving personal fees from Urovant and Entasis outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Diagram
AUDIT-C indicates Alcohol Use Disorder Identification Test–Consumption; DAA, direct-acting antiviral; HCV, hepatitis C virus; and SVR, sustained virologic response.
Figure 2.
Figure 2.. Patient Flow Diagram
AUDIT-C indicates Alcohol Use Disorder Identification Test–Consumption; DAA, direct acting antiviral; HCV, hepatitis C virus; SVR, sustained virologic response; and VA, US Department of Veterans Affairs. aParticipants could be identified in more than 1 exclusion criteria within each broad exclusion.
See this image and copyright information in PMC

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