Heavy Drinking Not Tied to Lower Response to DAAs for Hepatitis C

Alcohol use and alcohol use disorder (AUD) were not associated with lower odds of sustained virologic response to direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection, according to a retrospective cohort study of veterans.

Among over 69,000 patients who initiated DAA therapy, there was no evidence that any alcohol use category was significantly associated with decreased odds of sustained virologic response, reported Christopher T. Rentsch, PhD, of the London School of Hygiene & Tropical Medicine, and colleagues:

• Abstinence without AUD history: OR 1.09, 95% CI 0.99-1.20
• Abstinence with AUD history: OR 0.92, 95% CI 0.82-1.04
• Moderate-risk consumption: OR 0.96, 95% CI 0.80-1.15
• High-risk consumption or AUD: OR 0.95, 95% CI 0.85-1.07

There was also no evidence of interaction by stage of hepatic fibrosis measured by fibrosis-4 score (P=0.30), they noted in JAMA Network Open.

"Our findings suggest that DAA therapy should be provided and reimbursed despite alcohol consumption or history of AUD," Rentsch and team concluded. "Restricting access to DAA therapy according to alcohol consumption or AUD creates an unnecessary barrier to patients accessing DAA therapy and challenges HCV elimination goals."

Historically, clinicians have been reluctant to treat HCV patients with active alcohol use, due to the fact that patients were more likely to discontinue previously used interferon-based therapy, the authors noted. "However, for patients who successfully completed interferon-based therapy, comparable rates of sustained virologic response were achieved regardless of reported alcohol use."

While current American Association for the Study of Liver Diseases/Infectious Diseases Society of America HCV treatment guidelines recommend that patients avoid excess alcohol use, they do not recommend restricting access to DAA therapy on the basis of alcohol intake, regardless of any level of consumption, Rentsch and colleagues said.

"Despite these recommendations, some clinicians continue to delay or withhold HCV therapy from patients who consume alcohol," they added. "Furthermore, some payers include alcohol abstinence as a requirement for reimbursement of DAA therapy for HCV."

For this study, the authors used electronic health record data on 69,229 patients from the Department of Veterans Affairs, which does not restrict access to DAA HCV treatment based on a patient's alcohol use. Participants were born between 1945 and 1965 and were given DAA therapy between January 2014 and June 2018.

Of these patients, 84.5% had HCV genotype 1. Mean age was 62.6, 97% were men, 50.1% were white, and 40.6% were Black.

The cohort was divided into five groups based on alcohol consumption using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) questionnaire and the International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnoses for AUD:

• Abstinence without AUD (AUDIT-C score of 0 and absence of AUD diagnosis): 46.6% of patients
• Abstinence with AUD (AUDIT-C score of 0 and presence of AUD diagnosis): 13.3% of patients
• Lower-risk consumption (AUDIT-C score of 1-3 and absence of AUD diagnosis): 19.4% of patients
• Moderate-risk consumption (AUDIT-C score of 4-7 and absence of AUD diagnosis): 4.5% of patients
• High-risk consumption or AUD (AUDIT-C score of 8 or presence of AUD diagnosis with nonzero AUDIT-C score): 16.2% of patients

Sustained virologic response was defined as undetectable HCV RNA for 12 weeks or longer after completion of DAA therapy. Overall, 94.4% of the patients achieved sustained virologic response.

Rentsch and team noted that "a degree of uncertainty persists owing to the potential for residual confounding" due to the observational nature of their study.

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