Alcohol use and sustained virologic response to hepatitis C virus direct-acting antiviral therapy: a national observational cohort study

BackgroundSome payors and clinicians require alcohol abstinence for direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection. ObjectiveTo evaluate whether alcohol use at DAA treatment initiation was associated with decreased odds of sustained virologic response (SVR). DesignObservational cohort study using electronic health records. SettingUS Department of Veterans Affairs (VA), the largest integrated national healthcare system that provides unrestricted access to HCV treatment. PatientsAll patients born between 1945 and 1965 who were dispensed DAA therapy between 1 January 2014 and 30 June 2018. MeasurementsWe used multivariable logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs) of SVR associated with alcohol category. SVR was defined as undetectable HCV RNA [≥]12 weeks after completion of DAA therapy. Alcohol category was determined using information on alcohol use disorder diagnoses and Alcohol Use Disorders Identification Test - C (AUDIT-C) at DAA initiation. ResultsAmong 69,229 patients who initiated DAA therapy (mean age 63 years; 97% men; 50% non-Hispanic White; 41% non-Hispanic Black; 85% HCV genotype 1), 65,355 (94.4%) of patients achieved SVR. After multivariable adjustment, we found no difference in SVR across alcohol use categories (lowest OR 0.92, 95% CI 0.82-1.04). There was no evidence of interaction by stage of hepatic fibrosis measured by FIB-4 (p-interaction=0.3001). LimitationsPredominately male population. ConclusionAlcohol use was not associated with lower odds of SVR, suggesting that DAA therapy should not be withheld due to alcohol use. Restricting access to DAA therapy based on alcohol use creates an unnecessary barrier to patients and challenges HCV elimination goals. Funding sourceNational Institute on Alcohol Abuse and Alcoholism