No Need to Restrict Hep C DAA Therapy Based on Alcohol Use

TOPLINE:

Alcohol use at any level, including alcohol use disorder (AUD), is not associated with decreased odds of a sustained virologic response (SVR) to direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection. Therefore, DAA therapy should not be withheld from patients who consume alcohol.

METHODOLOGY:

• The researchers examined electronic health records for 69,229 patients (mean age, 63 years; 97% men; 50% non-Hispanic White) who started DAA therapy through the US Department of Veterans Affairs between 2014 and 2018.

• Alcohol use categories were abstinent without history of AUD, abstinent with history of AUD, lower-risk consumption, moderate-risk consumption, and high-risk consumption or AUD.

• The primary outcome was SVR, which was defined as undetectable HCV RNA for 12 weeks to 6 months after completion of DAA treatment.

TAKEAWAY:

• Close to half (46.6%) of patients were abstinent without AUD, 13.3% were abstinent with AUD, 19.4% had lower-risk consumption, 4.5% had moderate-risk consumption, and 16.2% had high-risk consumption or AUD.

• Overall, 94.4% of those who started on DAA treatment achieved SVR.

• After adjustment, there was no evidence that any alcohol category was significantly associated with decreased odds of achieving SVR. The odds ratios were 1.09 for abstinent without AUD history, 0.92 for abstinent with AUD history, 0.96 for moderate-risk consumption, and 0.95 for high-risk consumption or AUD.

• SVR did not differ by baseline stage of hepatic fibrosis, as measured by Fibrosis-4 score ≤ 3.25 vs > 3.25.

IN PRACTICE:

“[A]chieving SVR has been shown to be associated with reduced risk of post-SVR outcomes, including hepatocellular carcinoma, liver-related mortality, and all-cause mortality. Our findings suggest that DAA therapy should be provided and reimbursed despite alcohol consumption or history of AUD. 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.”

SOURCE:

Emily J. Cartwright, MD, of Emory University School of Medicine, Atlanta, Georgia, led the study, which was published online September 26 in JAMA Network Open.

LIMITATIONS:

The study was observational and subject to potential residual confounding. To define SVR, HCV RNA was measured 6 months after DAA treatment ended, which may have resulted in a misclassification of patients who experienced viral relapse. Most participants were men born between 1945 and 1965, and the results may not be generalizable to women and/or older and younger patients.

DISCLOSURES:

The study was supported by grants from the US National Institute on Alcohol Abuse and Alcoholism. Cartwright reported no disclosures. Two coauthors disclosed fees from pharmaceutical companies outside the submitted work.

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