Kayoko Sugawara1, Youhei Koushima2, Mie Inao1, Nobuaki Nakayama1, Sumiko Nagoshi3, Koji Yakabi3, Masaya Tamano4, Shinichi Asabe5, Ko Nishikawa6, Youji Harada7, Chuichi Sekine8, Yuji Fukuya9, Junji Funyu10, Yoshiaki Hashimoto11, Satoshi Mochida1. 1. Department of Gastroenterology and Hepatology, Saitama Medical University Hospital, Saitama Medical University, Saitama. 2. Department of Gastroenterology, Saitama Red Cross Hospital, Saitama. 3. Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Saitama. 4. Department of Gastroenterology, Dokkyo Medical University Koshigaya Hospital, Saitama. 5. Department of Gastroenterology, Saitama Medical Center, Jichi Medical University, Saitama. 6. Department of Gastroenterology Ageo Central General Hospital, Saitama. 7. Department of Gastroenterology Todachuo General Hospital, Saitama. 8. Saiseikai Kawaguchi General Hospital, Saitama. 9. Saiseikai Kurihashi General Hospital, Saitama. 10. Chichibu Hospital, Saitama. 11. Hakusei-Kai Aoki Hospital, Saitama, Japan.
Abstract
AIM: To optimize the therapeutic efficacy of NS3/4A protease inhibitors, a multicenter prospective study was performed according to an algorithm based on the Adherence, IL-28B Gene Allele and Viral Response Trial (AG & RGT). METHODS: A total of 340 patients with genotype 1b hepatitis C virus (HCV) showing serum RNA levels of >5 log were enrolled. The duration of ribavirin/pegylated interferon (PEG IFN)-α-2b therapy was prolonged to 48 weeks in patients with unfavorable IL28B alleles showing adherence rates of less than 80% for either drug during the first 12 weeks even if RVR had been achieved, and in those in whom cEVR, but not RVR, was achieved; furthermore, to 72 weeks in those showing partial early viral response. RESULTS: The therapeutic outcomes were assessed in 282 patients, and the therapy was set to complete at 24 weeks in 181 patients (64%) and to prolong to 48 weeks or 72 weeks in 71 patients (25%). The former group showed a SVR rate of 84%, while the latter group showed an SVR rate of 69% with a relapse rate of 7%. The SVR rate was 33% in the 30 patients (11%) in whom the therapy had to be discontinued in less than 12 weeks. Thus, the results of intention-to-treat analysis revealed an overall SVR rate of 75%. Multivariate analysis identified prolongation of the duration of therapy as a significant factor associated with SVR. CONCLUSION: Triple therapy yielded a high SVR rate in the AG & RGT trial via attenuation of viral relapse by prolonged ribavirin/PEG IFN-α-2b administration.
AIM: To optimize the therapeutic efficacy of NS3/4A protease inhibitors, a multicenter prospective study was performed according to an algorithm based on the Adherence, IL-28B Gene Allele and Viral Response Trial (AG & RGT). METHODS: A total of 340 patients with genotype 1b hepatitis C virus (HCV) showing serum RNA levels of >5 log were enrolled. The duration of ribavirin/pegylated interferon (PEG IFN)-α-2b therapy was prolonged to 48 weeks in patients with unfavorable IL28B alleles showing adherence rates of less than 80% for either drug during the first 12 weeks even if RVR had been achieved, and in those in whom cEVR, but not RVR, was achieved; furthermore, to 72 weeks in those showing partial early viral response. RESULTS: The therapeutic outcomes were assessed in 282 patients, and the therapy was set to complete at 24 weeks in 181 patients (64%) and to prolong to 48 weeks or 72 weeks in 71 patients (25%). The former group showed a SVR rate of 84%, while the latter group showed an SVR rate of 69% with a relapse rate of 7%. The SVR rate was 33% in the 30 patients (11%) in whom the therapy had to be discontinued in less than 12 weeks. Thus, the results of intention-to-treat analysis revealed an overall SVR rate of 75%. Multivariate analysis identified prolongation of the duration of therapy as a significant factor associated with SVR. CONCLUSION: Triple therapy yielded a high SVR rate in the AG & RGT trial via attenuation of viral relapse by prolonged ribavirin/PEG IFN-α-2b administration.