David M You, Douglas Hunt, Michael W Fried, David R Nelson, Andrea Scherschel , Bryan Still2 , Paul J Pockros
Background & Aims: Twice daily dosing of telaprevir in combination with peg interferon/ribavirin has not been extensively studied in treatment-naïve and treatment-experienced genotype 1 HCV patients, including a “real-world” setting. The purpose of this study was to assess the effectiveness and safety of telaprevir dosed at 1125 mg Q12 hr in treatment-naïve and treatment-experienced patients with genotype 1 chronic HCV infection in both a clinical study and “real-world” setting. Methods: A total of 163 subjects were evaluated in this study, including 103 treatment-naïve and treatment-experienced HCV genotype 1 patients who were treated prospectively with telaprevir 1125 mg Q12 hr along with peg interferon/ribavirin. In addition, we reviewed “real-world” data from a large multicenter longitudinal database (HCV-TARGET) of 60 treatment-naïve and treatment-experienced patients who received telaprevir dosed twice daily with peg interferon/ribavirin. Results: In a clinical study setting, the SVR 12 was 73% in treatment-naïve/relapsers and 41% in prior treatment-failures while in a “real-world” setting, the SVR 12 was 64% and 33%, respectively. Overall, treatment discontinuation due to adverse events occurred in 21% of treatment-naïve/relapsers and 53% of prior treatment-failures.
Conclusions: In our study, response rates to telaprevir taken twice daily appear to be similar to published sustained virologic rates for telaprevir taken every 8 hours for treatment of genotype 1 HCV infection for both treatment-naïve and treatment-experienced patients, although a lower SVR12 was seen in a “real-world” setting.
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