Once-daily simeprevir with peginterferon and ribavirin for treatment-experienced HCV genotype 1-infected patients in Japan: the CONCERTO-2 and CONCERTO-3 studies |
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Authors: | Namiki Izumi Norio Hayashi Hiromitsu Kumada Takeshi Okanoue Hirohito Tsubouchi Hiroshi Yatsuhashi Mai Kato Rito Ki Yuji Komada Chiharu Seto Shoichiro Goto |
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Institution: | 1. Musashino Red-Cross Hospital, Tokyo, Japan 2. Kansai Rosai Hospital, Hyogo, Japan 3. Toranomon Hospital, Tokyo, Japan 4. Saiseikai Suita Hospital, Osaka, Japan 5. Kagoshima University Medical and Dental Hospital, Kagoshima, Japan 6. National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan 7. Research and Development, Janssen Pharmaceutical K.K, Tokyo, Japan
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Abstract: | Background Efficacy of available therapies for patients with HCV who have previously failed treatment is limited. Two Phase III, open-label trials in Japan investigated efficacy and safety of simeprevir and peginterferon-α-2a/ribavirin (PR) combination therapy in treatment-experienced patients with genotype 1 HCV infection. Methods In CONCERTO-2, prior non-responders to IFN-based therapy (N = 106) received simeprevir (TMC435) 100 mg QD with PR for 12 (SMV12, n = 53) or 24 weeks (SMV24, n = 53) followed by response-guided therapy (RGT) with PR for 12/36 (SMV12) or 0/24 (SMV24) weeks. In CONCERTO-3, relapsers after IFN-based therapy (N = 49) received simeprevir 100 mg QD with PR for 12 weeks followed by RGT with PR for 12/36 weeks. Primary endpoints were the rates of sustained virologic response 12 weeks after treatment end (SVR12). Results SVR12 rates were 52.8 % (SMV12) and 35.8 % (SMV24) for prior non-responders, and 95.9 % for prior relapsers (SMV12; p ≤ 0.0001 vs null hypothesis, respectively). Most prior non-responders (SMV12: 81.1 %; SMV24: 73.6 %) and prior relapsers (95.9 %) met RGT criteria and completed PR to Week 24. Of these, 60.5 %, 48.7 %, and 95.7 %, respectively, achieved SVR12. Viral breakthrough occurred in 13.2 % (SMV12) and 11.3 % (SMV24) of prior non-responders; no viral breakthrough occurred in prior relapsers. Viral relapse occurred in 38.6 % (SMV12) and 51.1 % (SMV24) of prior non-responders and 8.2 % of prior relapsers. Simeprevir with PR was generally well tolerated in both studies. Conclusion Re-treatment with 12 weeks of simeprevir QD with PR provided high SVR in treatment-experienced patients with chronic HCV genotype 1 infection, and allowed most patients to complete treatment in 24 weeks. |
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