A RANDOMIZED CONTROLLED TRIAL OF RECOMBINANT INTERFERON-ALPHA-2B IN THE TREATMENT OF CHINESE PATIENTS WITH ACUTE POSTTRANSFUSION HEPATITIS-C

To evaluate the efficacy of recombinant interferon alpha-2b in the treatment of patients with acute post-transfusion hepatitis C, a randomized controlled trial was conducted in 33 acute post-transfusion hepatitis C patients; 16 patients received 3 million units of subcutaneously injected recombinant interferon alpha-2b 3 times a week for 3 months and 17 patients without specific treatment were used as controls. At the end of the interferon treatment, 13 (81%) patients in the interferon-treated group normalized serum alanine aminotransferase compared with only six (35%) patients in the control group (p<0.01). One year after completion of the interferon treatment, nine (56%) patients in the interferon-treated group and six (38%) patients in the control group normalized serum alanine aminotransferase (p=0.35). Serum HCV-RNA measured by reverse transcription-polymerase chain reaction was positive in all patients at the time of enrollment and then became undetectable in 13 (81%) patients in the interferon-treated group and two (12%) patients in the control group at the end of interferon treatment (p<0.001). One year after completion of the interferon treatment: seven (44%) patients in the interferon-treated group and two (13%) patients in the control group had persistent undetectable serum HCV-RNA (p=0.08). Using a logistic regression model, the lower pretreatment level of serum HCV-RNA measured by quantitative branched DNA signal amplification assay was the only predictor for a favorable response to the interferon treatment in acute hepatitis C patients. In conclusion, recombinant interferon alpha-2b treatment in patients with acute post-transfusion hepatitis C can successfully suppress viral RNA and lead to normalization of serum alanine aminotransferase. However, because of the low number of test subjects, no statistically significant difference in the long-term responses of interferon treatment were demonstrated between the interferon-treated and the control groups. (C) Journal of Hepatology.