EFFECT OF THERAPY WITH COMBINED INTERFERON AND TAUROURSODEOXYCHOLIC ACID IN CHRONIC HEPATITIS-C - BIOCHEMICAL AND VIROLOGICAL EVALUATION

Sixty men and women with biopsy-proven chronic hepatitis C were random ized to receive interferon (IFN) subcutaneously 3 million units three times a week (n = 30) or 3 million units three times a week with tauro ursodeoxycholic acid (TUDCA) 250 mg BID (n = 30) for 6 months. A follo w-up period of 3 months at the end of therapy was scheduled. Thirty-fo ur patients (56.7%) had normalized serum alanine aminotransferase leve ls at the end of therapy; 16 received IFN alone and 18 received IFN pl us TUDCA. Sixteen of these 34 patients (47.1%) relapsed in the follow- up period. No significant difference in relapse rate was observed betw een the two treatment groups. The overall percentage of nonresponders was 36.6%. Treatment was discontinued for noncompliance and/or side ef fects 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 t he start of treatment in all patients and became undetectable in almos t all responders. In some cases there was no correlation between virem ia and biochemical signs of liver disease. No virologic differences we re 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.