Alcohol Use Does Not Interfere with DAA Treatment of HCV

Neither alcohol use nor presence of hepatic fibrosis interferes with achieving sustained virologic response (SVR) with direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV), according to findings of a large cohort study conducted by the US Department of Veterans Affairs (VA).

Although current guidelines recommend DAA treatment of HCV regardless of alcohol use, "some clinicians continue to delay or withhold HCV therapy from patients who consume alcohol," observe Emily Cartwright, MD, Atlanta Veterans Affairs Medical Center, Decatur, GA and colleagues. "Furthermore, some payers include alcohol abstinence as a requirement for reimbursement of DAA therapy for HCV."

Concerns with alcohol use interfering with HCV treatment arose partly from the link to hepatocelluar damage and carcinoma, as well as finding that persons who consumed alcohol in early treatment programs were more likely to prematurely discontinue interferon treatment. Although use of alcohol does not now exclude persons from DAA treatment, Cartwright and colleagues acknowledge that evidence for the lack of interference with DAA treatment is limited to an observational study.

To provide updated, empirical data on the effect of alcohol use on cure of HCV, the investigators accessed the VA electronic health record data for approximately 70,000 patients who initiated interferon-free DAA therapy between January 2014 and June 2018. Alcohol consumption had been documented on the AUDIT-C measure, and by diagnosis of alcohol use disorder (AUD).

Five levels of alcohol consumption were defined from AUDIT-C score and diagnosis as: abstinent without AUD; abstinent with AUD; lower-risk consumption and absence of AUD diagnosis; moderate-risk consumption and absence of AUD; and high-risk consumption or AUD.Among covariates in the analysis were liver-related variables, including fibrosis 4 (FIB-4) score.

The cohort contained considerable variation of alcohol use: 46.6% abstinent without AUD; 13.3% abstinent with AUD; 19.4% with lower-risk consumption; 4.5% with moderate-risk consumption; and 16.2% had high-risk consumption or AUD. Overall, 94.4% of all DAA-initiating patients achieved SVR.

"In the fully-adjusted model, we found no evidence that any alcohol category was significantly associated with decreased odds of SVR (OR,1.09 [95% CI 0.99-1.20])," Cartwright and colleagues reported. "In addition, we found no evidence that the association of alcohol category with the odds of SVR differed by baseline stage of hepatic fibrosis (measured by FIB-4 less than or equal to 3.25 vs greater than 3.25)."

Despite these findings that support DAA therapy without regard of alcohol consumption or AUD, the investigators cite a recent analysis of administrative claims in the US, which found that only 23% of Medicaid, 28% of Medicare, and 35% of private insurance recipients initiated DAA treatment within 1 year of HCV diagnosis. That analysis also found Medicaid recipients less likely to initiate DAA treatment if they resided in states in which Medicaid treatment restrictions included alcohol abstinence.

"Our findings suggest that clinicians and policy makers should encourage HCV treatment in those with unhealthy alcohol consumption or AUD, rather than creating barriers to HCV treatment," Cartwright and colleagues advise. "Given the high rates of SVR across all alcohol use categories, there is no indication for payers to require alcohol abstinence before reimbursement of DAA therapy for HCV infection."