An open-label trial of consensus interferon 15 μg in the treatment of Chinese patients with chronic hepatitis C

Abstract

Consensus interferon (CIFN), a novel recombinant type 1 interferon (IFN), has been used recently to treat patients with chronic hepatitis C virus (HCV) infection. CIFN 9 μg, given subcutaneously 3 times a week for 24 weeks, offers sustained biochemical and virological responses in 32% of Chinese patients studied in Taiwan. Whether a higher dosage of CIFN will have greater efficacy is of clinical interest. This open-label trial was conducted to determine the efficacy and safety of CIFN 15 μg, given subcutaneously 3 times a week for 24 weeks, in 35 Chinese patients with chronic hepatitis C who in a previous randomized, controlled CIFN trial received placebo ( n=16) or showed no sustained response to CIFN 3 μg ( n=14) or 9 μg ( n=5), 3 times a week for 24 weeks. Efficacy was assessed by normalization of serum alanine transaminase (ALT) levels and clearance of serum HCV RNA to undetectable levels as measured by reverse-transcription polymerase chain reaction (RT-PCR). Results showed 14 of 35 patients (40%) achieved normalized serum ALT and cleared serum HCV RNA at the end of treatment, and 11 patients (31%) maintained a sustained response 24 weeks after treatment was discontinued. The sustained response rate was 31% in patients who had received a placebo injection in the previous trial, 36% in patients who had relapsed or not responded to previous CIFN 3 μg treatment, and 20% in patients who had relapsed or not responded to previous CIFN 9 μg treatment ( P>0.05). Upon re-treatment with CIFN 15 μg, sustained response was achieved in two of three patients who had relapsed from previous CIFN 3 μg treatment and in one of three patients who had relapsed from previous CIFN 9 μg treatment. CIFN 15 μg re-treatment achieved a sustained response in three of eleven patients and in none of two patients who were non-responders from previous CIFN 3 μg or CIFN 9 μg treatments respectively. Patients tolerated the treatment well, but two patients withdrew from the study due to intolerable side effects. In conclusion, subcutaneous injection of CIFN 15 μg, 3 times a week for 24 weeks, showed a similar efficacy as CIFN 9 μg 3 times a week treatment in Chinese patients with chronic hepatitis C. The treatment may benefit patients who have relapsed from a previous 3 μg or 9 μg treatment.