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Preciouslife1

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Preciouslife1

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Friday, 11/23/2007 9:29:13 AM

Friday, November 23, 2007 9:29:13 AM

Post# of 252891
Medivir to initiate Phase IIa study of hepatitis C

Datamonitor Pharmaceutical and HealthWire - Nov. 23, 2007
http://www.therapeuticsdaily.com/news/article.cfm?contenttype=sentryarticle&contentvalue=1617245&channelID=31

Medivir has announced that a Phase IIa study for its investigational hepatitis C protease inhibitor will start shortly in Europe by Tibotec Pharmaceuticals, who are collaborating with Medivir on the development of the drug.

The Phase IIa proof-of-concept trial is designed to assess the effectiveness, safety, tolerability, and pharmacokinetics of four different dose regimens of the drug, TMC435350 (25mg daily, 75mg daily, 200mg daily and 400mg daily).
In the trial, 96 treatment-naive and 24 treatment-experienced patients with chronic genotype-1 hepatitis C virus (HCV) infection will be enrolled at more than 20 sites in Europe. Patients will receive either TMC435350 or placebo once-daily for 28 days. Standard of care treatment, peginterferon alpha-2a (Pegasys) and ribavirin (Copegus), will be provided for 48 weeks or, optionally, for 24 weeks for those patients with an undetectable HCV viral load at week four and who remain undetectable at week 20. Patients will be followed-up for 24 weeks after the end of SoC to allow evaluation of sustained virologic response. In the Phase I study, TMC435350 was administrated at 200mg qd for five days to patients chronically infected with genotype-1 hepatitis C virus. The viral load reductions met the target set for the trial.
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