alpha-Interferon retreatment of patients with chronic hepatitis C

Abstract

To evaluate the effect of a second cycle of alpha-IFN treatment on patients who have not responded to a first cycle or responded and relapsed, 37 patients, 25 men and 12 women, mean age 41 yr, were retreated with alpha-interferon (IFN). Seven patients responded to the first cycle of treatment, and 30 did not. Five patients who had not responded to the second cycle received a third one. All patients received twice the dose of the first cycle unless they experienced side effects during the first cycle. Thus, nine patients received 9 mU/w, nine received 15 mU/w, and 19 received 30 mU/w for 6 months. Complete response was defined as nondetectable hepatic hepatitis C virus (HCV)-RNA at the end of therapy; sustained response was defined as normal ALT levels with negative serum HCV-RNA at > 6 months after cessation of therapy. Of the 30 nonresponders to the first cycle, eight responded to the second, but only four (13%) had a sustained response. Six of the seven responders to the first cycle responded to the second cycle, but only three had a sustained response (3/7, 43%) (p = NS). Although 33 and 21% (p = NS) of those who were treated with 15 mU/w and 30 mU/w, respectively, showed a sustained response, none of those treated with 9 mU/w had a sustained response (p = NS). Although age or sex of the patients studied had no effect on the response rate, liver histology was an important factor because only noncirrhotics showed a long term response (47 vs 0%; p < 0.02). There was no difference in response rate between patients with chronic active hepatitis and chronic persistent hepatitis. In conclusion, noncirrhotic patients who have not responded or responded and relapsed to a 6-month course of alpha-INF (3-5 mU three times per week) should try a second course at a dose of 15 mU/w. Retreatment may induce complete and long lasting response in 13% of the initial nonresponders and 43% of the initial responders. A second course of alpha-IFN in nonresponding cirrhotics appears ineffective in clearing the virus at the doses used.