Prospective study of interferon therapy for compensated cirrhotic patientswith chronic hepatitis C by monitoring serum hepatitis C RNA

Because interferon therapy exhibits low efficacy for cirrhotic patients inf ected with hepatitis C virus, this prospective study was conducted to deter mine effective interferon regimens tailored to treatment response by monito ring HCV RNA status. A total of 157 cirrhotic patients were enrolled to rec eive 9 million units (MU) of interferon three times a week. The HCV RNA val ues were drawn 8 weeks apart and the patients were randomized to a further 16 or 32 weeks of treatment after two sequential findings of negativity for HCV RNA. A total of 73 out of 157 patients (46%) proceeded to randomizatio n to different durations of treatment, 37 short-course and 36 long-course ( duration: 38 +/- 8 and 49 +/- 13 weeks; total amount of interferon: 940 +/- 240 and 1130 +/- 390 MU, respectively). The remaining 84 patients without two sequential negative serum HCV RNA determinations received 44.8 +/- 27.4 weeks of interferon (IFN) therapy with total amount of 993 +/- 633 MU. Of these 157 patients, sustained virological and biochemical response was show n in 32 (20%) and 37 patients (24%), respectively. Sustained virological an d biochemical response rate in the randomized patients was significantly hi gher than in nonrandomized patients (41% vs. 2%, and 38% vs. 11%; each P < .01). Of the 73 randomized patients, the rate of sustained virological resp onse in patients with long-course treatment (50%) was significantly higher than that of patients with short-course treatment (32%) (P = .026: log-rank test), and in patients with early disappearance of HCV RNA especially with in 8 weeks, in patients with low virus load (less than or equal to 10(6.3) copies/mL) and with HCV 2a, Multivariate analysis revealed that HCV RNA lev el and subtypes were the most important factors contributing to sustained v irological response. Interferon is effective even in cirrhotic patients wit h low viral load and HCV 2a, but requires a longer course of administration .