Alcohol Use Among Veterans with HCV Does Not Blunt SVR Rates from DAAs
BOSTON, MA—Nearly one-third of U.S. veterans with hepatitis C virus (HCV) infection treated with direct-acting antiviral (DAA) agents reported not abstaining from alcohol use over a 1-year period; yet, rates of sustained virologic response (SVR) remained high, results of a questionnaire reported at The Liver Meeting® 2016 have found.
This held true “even among persons with low-level and unhealthy alcohol use,” noted Judith Tsui, MD, MPH, University of Washington, Seattle, WA.
Whether alcohol use negatively impacts HCV treatment outcomes in the era of interferon-free DAAs is unknown. To examine the association between levels of drinking and DAA response, she and her colleagues screened Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaires administered in the Veterans Affairs (VA) healthcare system within one year prior to treatment initiation with DAAs.
Between January 1, 2014, and June 30, 2015, a total of 17,487 patients had initiated DAAs and 15,151 (87%) had completed an AUDIT-C questionnaire. These patients comprised the final study sample.
The DAAs included sofosbuvir, ledipasvir/sofosbuvir, and the PrOD (paritaprevir/ombitasvir/ritonavir + dasabuvir) regimen. The investigators defined SVR as a viral load below the limit of quantification (LLOQ) ≥12 weeks after the end of treatment; if SVR was unavailable, it was determined by viral load 4–12 weeks post-treatment.
AUDIT-C scores were categorized as 0 (abstinence), 1–3 (low-level drinking) and 4–12 (unhealthy drinking). Rates of SVR and 95% confidence intervals were calculated and multiple logistic regression models were performed, with and without imputing missing SVR data.
The sample was primarily male (96.7%); 28.9% were black; 30% had cirrhosis; and mean age was 61 ± 7 years. Distribution of HCV genotypes was 1 (79.8%), 2 (12.5%), 3 (7.0%), and 4 (0.8%). Alcohol abstinence was reported in 10,387 (68.5%); low-level drinking in 3,422 (22.6%); and unhealthy drinking in 1,342 (8.9%).
In the entire sample, no significant differences were observed in SVR rates between those who were abstinent (SVR 91.5%, 95% CI: 90.9, 92.0) or in the low-level (SVR 92.6%, 95% CI: 91.6, 93.5) or unhealthy drinking (SVR 90.8%, 95% CI: 89.0, 92.3) categories, nor were differences seen among subgroups defined by HCV genotype, cirrhosis, or HIV status.
“AUDIT-C categories were not significantly associated with SVR after adjustment for most important predictors of SVR in multivariable logistic regression models,” Dr. Tsui noted. Applying higher AUDIT-C cutoffs (10–12) was also deemed not significant. The authors reported little association between alcohol use and early discontinuation.
Dr. Tsui noted that after imputing for missing SVR data, the SVR rates were slightly lower and the AUDIT-C 4–12 category correlated with a lower SVR.
Since 2008, the VA has recommended annual administration of the AUDIT-C questionnaire to screen for unhealthy alcohol use. The authors concluded that DAAs "should potentially be offered to all patients irrespective of alcohol." For patients who do screen positive for unhealthy alcohol use in hepatology clinics, they recommend offering evidence-based alcohol-related interventions.