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Research Summary

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.


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 ( 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


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.