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Nearly 95% of patients with HCV treated with DAA therapy achieved SVR, regardless of alcohol consumption.
New findings from a retrospective cohort study of people with hepatitis C virus (HCV) suggest use of direct-acting antiviral (DAA) therapy was associated with sustained virologic response (SVR), regardless of alcohol consumption.
An analysis of nearly 70,000 patients, results of the study suggest 94.4% of patients with HCV achieved SVR regardless of alcohol use, with this association with SVR present among those with high-risk consumption or alcohol use disorder.1
“With the advent of safe and highly effective direct-acting antiviral therapy for HCV, the impact of alcohol use on achieving SVR is less clear,” wrote investigators.1
Globally, the World Health Organization estimates 58 million people have chronic HCV infection, with about 1.5 million new infections occurring every year. DAAs can cure more than 95% of people with HCV.2 HCV cure is confirmed when HCV RNA remains undetectable at 12 weeks after the end of treatment, known as SVR.3
To assess the impact of alcohol use at DAA treatment initiation on the likelihood of SVR, Emily Cartwright, MD, associate professor of medicine in the division of infectious diseases at Emory University School of Medicine, and a team of investigators collected electronic health records for patients who initiated DAA therapy between January 1, 2014 and June 30, 2018 from the US Department of Veterans Affairs. Of the 94,388 patients who initiated DAA therapy in this time frame, 14,057 had no information to define SVR in primary analyses and 7339 were missing data for body mass index, smoking status, fibrosis-4 score, or HCV genotype.1
In total, 69,229 patients with a mean age of 62.6 (standard deviation [SD], 4.5) years were included in the primary analysis. Among the cohort, 67,150 (97.0%) participants were male; 34,655 (50.1%) were non-Hispanic White, 28,094 (40.6%) were non-Hispanic Black, and 58,477 (84.5%) had HCV genotype 1. At DAA initiation, 46,220 (66.8%) patients were current smokers and 35,032 (50.6%) had fibrosis 4 scores between 1.45 and 3.25.1
The primary exposure variable combined information on alcohol consumption and alcohol use disorder diagnoses ascertained in the 18 months before the index date. Investigators generated alcohol use categories based on AUDIT-C scores and alcohol use disorder diagnoses, including abstinent without history of alcohol use disorder, abstinent with history of alcohol use disorder, lower-risk consumption, moderate-risk consumption, and high-risk consumption or alcohol use disorder.1
The primary outcome of interest was SVR, which was defined as undetectable HVC RNA for 12 weeks or longer and less than 6 months after completion of DAA therapy. Investigators also considered covariates including age, sex, race, ethnicity, rural or urban residency type, body mass index, smoking status, HIV coinfection, Charlson Comorbidity Index score, liver-related variables, and other HCV treatment-related variables.1
A total of 32,290 individuals (46.6%) were abstinent without alcohol use disorder, 9192 (13.3%) were abstinent with alcohol use disorder, 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 alcohol use disorder.1
Among the cohort, 65,355 (94.4%) participants achieved SVR. In an unadjusted model, patients who were abstinent without alcohol use disorder history (odds ratio [OR], 0.89; 95% confidence interval [CI], 0.81-0.97) and those who were abstinent with alcohol use disorder history (OR, 0.71; 95% CI, 0.64-0.80) had lower odds of achieving SVR compared to patients who reported lower-risk consumption. Upon adjustment, there was no evidence of a significant association between alcohol category and odds of SVR, even for patients with high-risk consumption or alcohol use disorder (OR, 0.95; 95% CI, 0.85-1.07). Investigators also pointed out the association of alcohol category with the odds of SVR did not differ between participants with baseline stage of hepatic fibrosis ≤ 3.25 compared to > 3.25 (P for interaction = .30).1
Findings persisted after investigators included patients with missing data using multiple imputation (lowest adjusted OR, 0.90; 95% CI, 0.80-1.02 for patients who were abstinent with alcohol use disorder history) and assuming all patients with missing outcome data achieved SVR (lowest adjusted OR, 0.94; 95% CI, 0.84-1.06 for patients who were abstinent with alcohol use disorder history).1
“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,” investigators concluded.1