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The purpose of the study is to explore the safety and effectiveness of each treatment combination and to study the amount of telaprevir in the blood. Two different doses of telaprevir (750 mg every 8 hours, and 1125 mg every 12 hours) will be studied in combination with the two standard therapies commercially available for chronic Hepatitis C Virus infection. Telaprevir will be administered for 12 weeks in combination with 24 weeks of standard therapy. In case of sub-optimal response, standard therapy will be extended to 48 weeks
http://biz.yahoo.com/bw/080107/20080107005882.html?.v=1
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Tibotec Leading Two Clinical Trials of Telaprevir in Europe
"Tibotec initiated in late 2007 a Phase 2 clinical study in Europe to evaluate 8-hourly and 12-hourly dosing of telaprevir in combination with pegylated interferon (Pegasys® or Pegintron®) and ribavirin. Patients are currently being dosed in this trial. Interim 12-week on-treatment data are expected to be available in the second half of 2008.
Tibotec is also conducting a Phase 2 viral kinetics study in Europe to evaluate telaprevir in patients infected with genotype 2/3 HCV. Patients are currently being screened in this trial, and interim on-treatment data are expected to be available in late 2008. "
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Info on Phase 3 may be out witin the monthat the yearly financial meeting.
Willy
You stated that "In case of sub-optimal response, standard therapy will be extended to 48 week. "
Do you happen to know exactly what defines "sub-optimal response"? I'm interested since I'm in a vertex rollover trial - after relapsing in Prove 1 (I received 48 weeks of SOC in the placebo arm). The study I'm in is only for 24 weeks total (12 weeks w/ telaprevir & 24 weeks SOC). I was curious if you knew what defines sub-optimal response for this new trial.
Deb