TREATMENT OF RELAPSES IN PATIENTS WITH CHRONIC HEPATITIS-C WITH RECOMBINANT ALPHA-INTERFERON

Fifty-six patients with chronic hepatitis C who responded to 6 months' treatment with recombinant alpha-interferon (rIFN alpha), 3MU 3 times weekly, were randomly enrolled into 2 groups (A and B) and followed u p for 38 months in the following manner: patients in group A, who agai n had increases in alanine amino-transferase (ALT) levels, received a second 6-month course of the same type and dose of interferon (IFN); p atients who showed a further relapse in the next 12 months were immedi ately submitted to a third B-month course with the same IFN and follow ed up to the sixth month after IFN withdrawal. Patients in group B did not receive any treatment after the first course, and were used as th e control group. Patients with other potential causes of chronic liver disease, with histological diagnosis of cirrhosis or with abnormal AL T levels were excluded. Liver function tests were performed every 2 mo nths. Serum HCV-RNA was determined every 12 months when the patients c ontinued to show normal ALT levels, and it was evaluated before and af ter IFN retreatment if ALT levels again increased. There were 5 dropou ts (8.9%). 41.1% of the patients did not show relapses. At the end of the study, 7 (43.7%) of the 16 patients, who were retreated because of relapse, again showed abnormal ALT values; while in the control group there were 14 (58.3%) relapses. This difference was not statistically significant. A complete response, exclusively defined by a normalisat ion of aminotransferase levels with disappearance of serum HCV-RNA, wa s only achieved in the patients with undetectable HCV-RNA at the begin ning of the study: in fact HCV-RNA, if present in serum after the firs t IFN course, did not disappear after the following cycles. We conclud ed that the retreatment of relapses with rIFN alpha was of little bene fit, even if it could lead to a complete response in some patients wit h undetectable serum KCV-RNA after the first IFN course.