Baclofen: New Hope for Alcohol Abstinence in Patients with Alcohol- and HCV-related Cirrhosis?
Alcohol use and hepatitis-C virus (HCV) infection, either alone or in combination, account for two-thirds of all liver disease in the Western world. Because alcohol consumption accelerates HCV-related liver fibrosis, no safe level of drinking exists in patients with HCV, and total abstinence is recommended. Baclofen, a GABAB receptor agonist, is a potential therapeutic agent for alcohol dependence. This post-hoc analysis of a positive clinical trial of baclofen for the treatment of alcohol dependence in patients with cirrhosis explored whether the safety and efficacy of baclofen was also evident in a subgroup of patients with HCV. Of 84 patients enrolled in the main trial, 24 had alcohol dependence, HCV infection, and cirrhosis. Of these, 12 patients received baclofen (10 mg orally 3 times per day) and 12 received placebo for 12 weeks.
- Ten patients receiving baclofen, compared with 3 receiving placebo, achieved total alcohol abstinence (p=0.01).
- In the baclofen group, compared with placebo, albumin values increased, and a trend toward reduction in international normalized ratio (INR) levels was demonstrated.
- No patients discontinued baclofen due to side effects.
Comments:
In this post-hoc subgroup analysis of data from a larger randomized controlled trial, baclofen shows promise for improving alcohol abstinence among alcohol-dependent HCV-infected patients with cirrhosis. But at least 1 other study has found no efficacy for baclofen for alcohol-dependent patients with cirrhosis (www.bu.edu/aodhealth/issues/issue_sept10/saitz_garbutt.html). Nonetheless, if these results are replicated in larger clinical trials, baclofen would be a welcome pharmacotherapy for those with cirrhosis and HCV infection.
Jeanette M. Tetrault, MD
Reference:
Leggio L, Ferrulli A, Zambon A, et al. Baclofen promotes alcohol abstinence in alcohol dependent cirrhotic patients with hepatitis C virus (HCV) infection. Addict Behav. 2012;37(4):561–564.