Effect of therapy with combined interferon and tauroursodeoxycholic acid in chronic hepatitis C: Biochemical and virologic evaluation

Abstract

Sixty men and women with biopsy-proven chronic hepatitis C were randomized to receive interferon (IFN) subcutaneously 3 million units three times a week (n=30) or 3 million units three times a week with tauroursodeoxycholic acid (TUDCA) 250 mg BID (n=30) for 6 months. A follow-up period of 3 months at the end of therapy was scheduled. Thirty-four patients (56.7%) had normalized serum alanine aminotransferase levels at the end of therapy; 16 received IFN alone and 18 received IFN plus TUDCA. Sixteen of these 34 patients (47.1%) relapsed in the follow-up period. No significant difference in relapse rate was observed between the two treatment groups. The overall percentage of nonresponders was 36.6%. Treatment was discontinued for noncompliance and/or side effects in four patients (6.7%), two in the IFN group and two in the IFN plus TUDCA group. Hepatitis C virus-ribonucleic acid was evident at the start of treatment in all patients and became undetectable in almost all responders. In some cases there was no correlation between viremia and biochemical signs of liver disease. No virologic differences were found between treatment groups. The tendency toward a reduced, but not significant, relapse rate in patients treated with IFN plus TUDCA must be confirmed in studies using a larger sample size.