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 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 (<italic>P</italic> = 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. [ABSTRACT FROM AUTHOR]