Fumitaka Suzuki1, Yoshiyuki Suzuki1, Hitomi Sezaki1, Norio Akuta1, Yuya Seko1, Yusuke Kawamura1, Tetsuya Hosaka1, Masahiro Kobayashi1, Satoshi Saito1, Yasuji Arase1, Kenji Ikeda1, Rie Mineta2, Sachiyo Watahiki2, Mariko Kobayashi2, Yoshiyuki Nakayasu3, Hidetaka Tsuda3, K. Aoki3, Itsunari Yamada3, Hiromitsu Kumada1
1Department of Hepatology, Toranomon Hospital, Tokyo, Japan
2Research Institute for Hepatology, Toranomon Hospital, Tokyo, Japan
3Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
Tóm tắt
AimThe aims of this study are to assess the antiviral effects, safety and telaprevir (TVR) pharmacokinetics in two cohorts given TVR every 8 h (q8h) at doses of 500 mg and 750 mg with peginterferon‐α‐2b and ribavirin in chronic hepatitis C patients.MethodsTwenty chronic hepatitis C (HCV) patients with genotype 1b in high viral loads were randomly assigned to two TVR‐based regimens of 750 mg q8h (group A) and 500 mg q8h (group B) in combination with peginterferon‐α‐2b and ribavirin for 12 weeks.ResultsAlthough the difference was not statistically significant other than trough concentration (Ctrough) at week 4, the parameters of maximum concentration (Cmax), the area under the concentration time curve (AUC0–∞) and Ctrough tended to be higher in group A than those in group B. The antiviral effects were similar in the two groups (sustained virological response rates [SVR], 40% in group A, 50% in group B). The discontinuation rates by anemia were 30% in group A and 20% in group B. Serum creatinine concentrations were lower in group B than those in group A.ConclusionAlthough the exposure to TVR tended to be lower in 500 mg q8h than that in 750 mg q8h, the SVR rates in both groups were similar. The result suggests that the 500 mg q8h dose may be one option for treatment. In addition, the present findings indicate that the development of adverse events which increase with a TVR‐based regimen, specifically anemia and creatinine, could be avoided by dose adjustment of TVR.
