Clinical Studies Randomized trial of three different regimens for 24 weeks for re-treatment of chronic hepatitis C patients who failed to respond to interferon-a monotherapy in Taiwan Wan-Long Chuang, Chia-Yen Dai, Shinn-Cherng Chen, Li-Po Lee, Zu- Yau Lin, Ming-Yuh Hsieh, Liang-Yen Wang, Ming-Lung Yu and Wen-Yu Chang Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan Chuang W-L, Dai C-Y, Chen S-C, Lee L-P, Lin Z-Y, Hsieh M-Y, Wang L-Y, Yu M-L, Chang W-Y. Randomized trial of three different regimens for 24 weeks for re-treatment of chronic hepatitis C patients who failed to respond to interferon-a monotherapy in Taiwan. Liver International 2004: 24: 595–602. r Blackwell Munksgaard 2004 Abstract: With the favorable result of interferon (IFN)–ribavirin combination therapy for 24 weeks among naive Taiwanese chronic hepatitis C (CHC) patients, the optimal regimens of re-treatment for CHC patients who failed initial IFN monotherapy is not well-established. The study evaluated the effectiveness of re-treatment for 24 weeks with 3 different regimens and predictors for sustained virological response (SVR). Methods: Total 120 Taiwanese CHC patients (81 males, 70 relapsers, mean age: 48.6 years) who failed initial IFN monotherapy were enrolled. They were assigned randomly (with a ratio of 1:1:2) to receive one of the three regimens for re-treatment for 24 weeks; group A: IFN 6 million units (MU) monotherapy (N 5 30), group B: combination therapy with ribavirin and IFN 3 MU (N 5 30) or group C: combination therapy with ribavirin and IFN 6 MU (N 5 60). The intention-to-treat rate of sustained virological response (SVR) was 38.3%. The SVR rate in group C (53.3%) was significantly higher than group A (16.7%, Po0.005) and group B (30%, Po0.05). Drop-out rates were similar between the three groups. Patients achieving SVR had significant improvement histologically. Hepatitis C virus (HCV) genotype non-1b infection, lower pretreatment HCV RNA levels, combined with ribavirin and with higher IFN dose, and relapsers were independent predictors for SVR. Conclusion: We concluded that more than one-third Taiwanese CHC patients achieved SVR after 24 weeks re-treatment and combination therapy, especially with higher dose of IFN, yielded higher efficacy. Key words: chronic hepatitis C – combination therapy – interferon – ribavirin – re-treatment Dr. Ming-Lung Yu, Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospi- tal, No. 100, Tz-You 1st Rd, Kaohsiung 807, Taiwan. Tel: 1886 7 3121101 ext., 7475 Fax: 1886 7 3123955 e-mail: d780178@kmu.edu.tw d820195@kmu.edu.tw Received 19 January 2004, accepted 26 April 2004                                                                                             Hepatitis C virus (HCV) is the major etiologic agent in parenterally transmitted non-A non-B hepatitis and frequently causes persistent infec- tion and leads to chronic liver disease and pri- mary hepatocellular carcinoma (1, 2). Interferon- a (IFN) was the first approved therapy and resulted in a sustained virological response (SVR) in only 8–20% of chronic hepatitis C (CHC) patients treated with a standard regimen of IFN monotherapy, 3 million units (MU) thrice weekly for 24 weeks (3–7). In 1997, the Consensus panel of the first Consensus Development Con- ference recommended a course of IFN at a dose of 3 MU thrice weekly for 48 weeks as the optimal therapy for the treatment of this disease (8). Considerable advances for CHC have been made after introducing the IFN–ribavirin combi- nation therapy. Previous reports have demon- strated the increased rate of SVR to 31–43% after the combination therapy for 24 or 48 weeks than 6–19% of IFN monotherapy (9, 10). The SVR rate reported by Lai et al. (11) from Taiwan achieved 43% after combination therapy with IFN 3 MU and ribavirin for 24 weeks. For patients with CHC, the combination therapy has been considered as first-line therapy. Re-treatment for patients who failed to IFN monotherapy is another important issue. A sec- ond course of IFN monotherapy had been used to retreat those who relapsed after achieving an end-of-treatment virological response (ETVR) (relapser) and the rates of SVR were reported Liver International 2004: 24: 595–602 Printed in Denmark. All rights reserved Copyright r Blackwell Munksgaard 2004 DOI: 10.1111/j.1478-3231.2004.0954.x 595