Hepatology research : the official journal of the Japan Society of Hepatology · 2012
Exploratory study on telaprevir given every 8 h at 500 mg or 750 mg with peginterferon-alpha-2b and ribavirin in hepatitis C patients.
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Suzuki Fumitaka, Suzuki Yoshiyuki, Sezaki Hitomi, Akuta Norio, Seko Yuya, Kawamura Yusuke, Hosaka Tetsuya, Kobayashi Masahiro, Saito Satoshi, Arase Yasuji, Ikeda Kenji, Mineta Rie, Watahiki Sachiyo, Kobayashi Mariko, Nakayasu Yoshiyuki, Tsuda Hidetaka, Aoki Keiji, Yamada Ichimaro, Kumada Hiromitsu
Аннотация
AIM: The 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.
METHODS: Twenty 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.
RESULTS: Although 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.
CONCLUSION: Although 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.
METHODS: Twenty 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.
RESULTS: Although 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.
CONCLUSION: Although 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.