Efficacy and safety of telaprevir with natural human interferon‐β and ribavirin in Japanese chronic hepatitis C patients with depression

Aim To assess the efficacy and safety of telaprevir (TVR) when used in combination with natural human interferon‐β (IFN‐β) and ribavirin (RBV) for genotype 1 patients with depression compared to IFN‐β/RBV therapy in Japan. We also examined the efficacy of the TVR/IFN‐β/RBV therapy in treatment failu...

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Published inHepatology research Vol. 48; no. 2; pp. 184 - 192
Main Authors Kumada, Hiromitsu, Mochida, Satoshi, Nakamuta, Makoto, Suzuki, Fumitaka, Yagi, Takashi, Takasaki, Ryuji, Okai, Masao, Kamiya, Naohiro, Okada, Yasushi, Hirota, Saya, Orihashi, Madori, Ochi, Miyoko, Chayama, Kazuaki
Format Journal Article
LanguageEnglish
Published Netherlands 01.02.2018
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Summary:Aim To assess the efficacy and safety of telaprevir (TVR) when used in combination with natural human interferon‐β (IFN‐β) and ribavirin (RBV) for genotype 1 patients with depression compared to IFN‐β/RBV therapy in Japan. We also examined the efficacy of the TVR/IFN‐β/RBV therapy in treatment failure genotype 2 patients with depression. Methods For the genotype 1 patients, 30 patients received TVR (750 mg every 8 h) for 12 weeks combined with IFN‐β and RBV for 24 weeks (Group A), and 30 received IFN‐β and RBV for 48 weeks (Group B). For the genotype 2 patients, 14 patients were dosed only with the TVR‐based regimen. Results The sustained virologic response (SVR) rates for Group A and Group B were 63.3% and 20.0%, respectively (P = 0.001, likelihood ratio test). The SVR rate for genotype 2 patients previously treated with pegylated IFN and/or RBV was 71.4%. No patient dropped out due to exacerbation of depression. The trend of platelet counts after the drugs were given was similar in the TVR/IFN‐β/RBV therapy group and the IFN‐β/RBV therapy group. Common resistance‐associated variants of TVR were identified in 4 of the 13 patients who did not achieve SVR. Conclusion This study showed that an addition of TVR to IFN‐β/RBV therapy raised SVR in previously treated and untreated genotype 1 patients and previously treated genotype 2 patients with chronic hepatitis C and depression.
Bibliography:This clinical trial was funded by Mitsubishi Tanabe Pharma Corporation and Toray Industries, Inc. The sponsors were involved in the trial design, conduct, and data analysis.
Conflict of interest
Hiromitsu Kumada received lecture fees from MSD K.K, EA Pharma Co., Ltd., Sumitomo Dainippon Pharma, Toray Industries, Inc., GlaxoSmithKline K.K, Bristol‐Myers Squibb, Mitsubishi Tanabe Pharma Corporation, Janssen Pharmaceutical K.K, AbbVie GK, Otsuka Pharmaceutical Co., Ltd., and Gilead Sciences, Inc. Kazuaki Chayama received lecture fees from MSD K.K, Bristol‐Myers Squibb, Abbvie, Ajinomoto, Abbott, Astellas, Chugai, Dainippon Sumitomo, Gilead, and Mitsubishi‐Tanabe, and research funding from Bristol‐Myers Squibb, Toray, MSD K.K, Dainippon Sumitomo, and Mitsubishi Tanabe. Satoshi Mochida received patent royalties/licensing fees from SRL Inc., lecture fees from Bristol‐Myers Squibb, Toray Medical Co. Ltd., Gilead Sciences Inc., Abbvie GK, Ajinomoto Pharmaceuticals Co. Ltd., MSD K.K., and Sumitomo Dainippon Pharma, and research funding from Bristol‐Myers Squibb, Tanabe Mitsubishi Pharma Co., MSD K.K., A2 Healthcare Co., Toray Medical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd., Takeda Pharmaceutical Co. Ltd., and Abbvie GK. Makoto Nakamuta received lecture fees from MSD and Bristol‐Myers Squibb. Research funding from Bristol‐Myers Squibb. Fumitaka Suzuki received lecture fees from Bristol‐Myers Squibb. The other authors have no conflict of interest.
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ISSN:1386-6346
1872-034X
DOI:10.1111/hepr.12914