RETREATMENT OF INTERFERON-RESISTANT PATIENTS WITH CHRONIC HEPATITIS-CWITH INTERFERON-ALPHA

Non-responders to 6-months treatment with recombinant interferon (rIFN )-alpha, 3 MU thrice weekly (primary non-responders) were treated for 6 further months with the same therapy or with a double dose of rIFN-a lpha or with a different type of IFN (L-IFN), 112 primary non-responde rs were randomly enrolled into four groups of 28 patients each over a period of 4 years and were followed up for 6 months: group A continued the same dose of rIFN-alpha, group B was treated with the same rIFN-a lpha but received a double dose (6 MU thrice weekly), group C received L-IFN, 3 MU thrice weekly, and group D stopped IFN therapy and did no t receive any treatment. Patients were examined at monthly intervals a nd response was defined as a complete normalization of alanine amino t ransferase (ALT), The four groups were homogeneous as to age, sex, dur ation of the disease, probable source of infection, histological diagn osis, ALT and gamma glutamyl transferase (gamma GT) levels, No patient discontinued therapy for side-effects. Further treatment with rIFN-al pha 3 MU thrice weekly (group A) induced normalization of ALT levels i n four patients (14%); treatment with double-dosed rIFN-alpha (group B ) induced normalization of liver enzymes in six cases (21%); a differe nt type of interferon (L-IFN) (group C) achieved normalization of seru m ALT in five patients (18%). None of 28 primary non-responders who di d not receive any treatment (group D) showed normalization of ALT leve ls. None of the patients was anti-HCV negative at the end of the study and no statistically significant difference was noted between respond ers and non-responders to the second course of IFN therapy as to age, sex, duration of the disease, ALT and gamma GT levels at the end of th e trial, Overall at the end of the study the primary non-responders wi th normal levels of ALT were 15/112 (13%), with a therapeutic advantag e of 7%. No statistically significant difference in the response rate was found among patients who continued IFN therapy, but prolongation o f rIFN-alpha treatment at double dosage seems to be the best therapeut ic regimen.