Hepatitis C Alcohol Reduction Treatment

For people infected with hepatitis C virus (HCV), alcohol use increases the risk of
hepatocellular carcinoma and progressive liver fibrosis, which can lead to cirrhosis and
liver-related mortality. Integrated models of care that incorporate treatment for alcohol
use, substance use, and mental health comorbidities have been called for, but few empirically
tested models exist.

In an R21 study, we developed and manualized an integrated behavioral-medical treatment model
for patients with HCV who consume alcohol. Investigators successfully implemented a
standardized alcohol screening in a liver clinic using the Alcohol Use Disorders
Identification Test (AUDIT) instrument; recruited 60 patients; retained participants in group
and individual therapy; integrated care between an addictions therapist and medical
providers; and achieved an 85% six-month interview response rate. The alcohol abstinence rate
improved from 0% at baseline to 44% at 6 months. Mean Addiction Severity Index scores were
reduced by 50% for alcohol from .24 to .12, and decreased for drug use from .05 to .03. The
percentage of heavy drinkers decreased from 47% to 24% (Proeschold-Bell et al., 2011).

This study will conduct a randomized controlled trial that compares medical
provider-delivered brief alcohol counseling plus our on-site six-month integrated treatment
to brief alcohol counseling plus outside alcohol treatment referral in 279 HCV-infected
patients with qualifying AUDIT alcohol scores at baseline. Participants in both arms will be
treated at the Duke and UNC Liver Clinics and the Durham Veterans Affairs Medical Center.
Outcome variables will be assessed at baseline, 3, 6, and 12 months. The aims are to 1)
evaluate alcohol abstinence; 2) determine differences in secondary outcomes between study
arms; and 3) conduct a cost effectiveness analysis. Investigators hypothesize that the
intervention will significantly improve alcohol abstinence rates and significantly decrease
relapse rates compared to the comparison. Investigators further hypothesize that intervention
participants will report fewer drinks per week than comparison participants, have fewer
positive drug screens than comparison participants, and meet the $50,000 per quality-adjusted
life year gained standard established in the health economics literature.

Inclusion criteria

- Ever HCV-infected chronic HCV

- Appropriate score on the Alcohol Use Disorder Identification Test (AUDIT)

- Females, ≥4

- Males, ≥8

- Consumed alcohol in past 60 days

- Not currently attending alcohol treatment services more than once every two weeks. If
you attend treatment services at least once every two weeks, you must have either
drunk alcohol heavily in the past 2 weeks or have drunk alcohol at least 7 of the past
14 days or your medical provider must have assessed that you would benefit from
alcohol treatment services offered by this study

* Patient at one of the 3 clinic sites

- 18 or older

- English-speaking

- OK to have HIV, substance use or other co-morbidities, or receiving HCV antiviral
treatment

Exclusion criteria

- Psychotic

- Insurmountable transportation barriers (can receive individual therapy by phone but
need appointments with HCV provider at 3 and 6 months and ideally some in-person group
therapy)