Yoshinori Ozono, Yuka Takaishi, Mai Tsuchimochi, Kenichi Nakamura, Hiroo Abe, Tadashi Miike, Kazunori Kusumoto, Hisayoshi Iwakiri, Mitsue Sueta, Yoshihiro Tahara, Shojiro Yamamoto, Satoru Hasuike, Kenji Nagata and Kazuya Shimoda
Objective: Rapid virological response (RVR), defined as undetectable serum hepatitis C virus (HCV) RNA at week 4, is a useful predictor of sustained virological response (SVR) to peginterferon (PEG-IFN) plus ribavirin (RBV) therapy and protease inhibitor (telaprevir (TVR)/simeprevir (SMV)) based triple therapy for patients infected with genotype 1 HCV. The aim of this study was to predict SVR using viral response within 2 weeks of therapy initiation.
Methods: Fifty-two HCV genotype 1b patients with high viral loads treated with protease inhibitor (TVR/SMV)- based triple therapy were analysed. Thirty-seven patients were treated with TVR-based triple therapy and 15 with SMV-based triple therapy. HCV RNA levels were measured at the following points: the day of therapy initiation, at days 1 and 3, and at weeks 1 and 2.
Results: SVR was achieved in 87% (45/52) of patients. There was no difference in SVR rate between the TVRbased triple therapy group (92%) and the SMV-based triple therapy group (73%) (P=0.1726). Univariate analysis of contributors to SVR showed a significant effect of liver fibrosis, platelet count, aspartate transaminase, α-fetoprotein in terms of pre-treatment factors, and HCV RNA load at week 2, reduction of HCV RNA at day 1 and week 2, RVR, and PEG-IFN adherence in terms of on-treatment factors. By multivariate analysis, platelet count and HCV RNA load at week 2 were independently associated with high SVR rate.
Conclusion: HCV RNA level at week 2 was the most useful predictor of SVR after TVR/SMV-based triple therapy in patients with genotype 1 HCV.