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

Consensus interferon (CIFN), a novel recombinant type 1 interferon (IFN), h as been used recently to treat patients with chronic hepatitis C virus (HCV ) infection. CIFN 9 mug, given subcutaneously 3 times a week for 24 weeks, offers sustained biochemical and virological responses in 32% of Chinese pa tients studied in Taiwan. Whether a higher dosage of CIFN will have greater efficacy is of clinical interest, This open-label trial was conducted to d etermine the efficacy and safety of CIFN 15 mug, given subcutaneously 3 tim es 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 mug (n = 14) or 9 mug (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 undetec table 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 discontinue d. The sustained response rate was 31% in patients who had received a place bo injection in the previous trial, 36% in patients who had relapsed or not responded to previous CIFN 3 mug treatment, and 20% in patients who had re lapsed or not responded to previous CIFN 9 mug treatment (P > 0.05). Upon r e-treatment with CIFN 15 mug, sustained response was achieved in two of thr ee patients who had relapsed from previous CIFN 3 mug treatment and in one of three patients who had relapsed from previous CIFN 9 mug treatment. CIFN 15 mug re-treatment achieved a sustained response in three of eleven patie nts and in none of two patients who were non-responders from previous CIFN 3 mug or CIFN 9 mug treatments respectively. Patients tolerated the treatme nt well, but two patients withdrew from the study due to intolerable side e ffects. In conclusion, subcutaneous injection of CIFN 15 mug, 3 times a wee k for 24 weeks, showed a similar efficacy as CIFN 9 mug 3 times a week trea tment in Chinese patients with chronic hepatitis C. The treatment may benef it patients who have relapsed from a previous 3 mug or 9 mug treatment. (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.