Effect of a combination therapy with interferon and ofloxacin for chronic type C hepatitis - A multicenter randomized trial

Interferon (IFN) is effective in only a limited number of patients with hepatitis C virus (HCV) type 1 b, indicating that a combination therapy with other antiviral drugs may be essential to obtain better results. In the present study, the effects of a combination therapy with IFN and an antibacterial drug, ofloxacin (OFLX), were analyzed by a multicenter randomized trial. Over 6 million units of various types of IFN were given with 600 mg of OFLX per day to 72 patients with chronic type C hepatitis in 9 different hospitals. The schedule of the combination therapy was categorized into 3 types. In 35 patients who have no IFN therapy previously, IFN was given daily for 2-3 weeks and then 3 times for 21-22 weeks. OFLX was given for 12 weeks from the 8th week of IFN treatment (group I). In 8 patients, who did not respond well to IFN-alone treatment for more than 12 weeks, OFLX was given with IFN for more than 12 weeks (group II). In 14 patients who were non-responders of IFN-alone treatment for 24 weeks, combination therapy was conducted in the same schedule for group I (group III). In group I, 15 of 25 patients with HCV-1 b were responders who were continued normal ALT levels for 6 months after ceasing treatment. In other HCV subtypes, 7 of 10 patients were responders. In group II, responder was found in 5 of 6 patients with HCV-1 b and 1 out of 2 patients with other subtypes. In group III, responders were found in 4 out of 9 patients with HCV-1 b and in 4 out of 5 patients with other subtypes. The incidence of responders was higher than the previously reported values with IFN alone treatment. Severe side effect was found only 3 patients. These results suggest that a combination therapy with IFN and OFLX is an effective treatment for type C hepatitis.