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Prediction of Sustained Virological Response to Telaprevir/Simeprevir-Based Triple Therapy in Patients with Genotype 1 Hepatitis C Virus Using Super-Early Viral Response within 2 Weeks

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.