Risk Of Developing Liver Cancer After HCV Treatment

Tuesday, November 30, 2010

Interim Results TMC435 Works in Treatment-experienced Hepatitis C Patients

NATAP
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(11/29/10)
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HIV and AIDS - Top News Articles Posted November 30, 2010
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SUMMARY: Vertex Pharmaceuticals announced last week that it has completed its submission of data to the U.S. Food and Drug Administration (FDA) in support of its New Drug Application for the oral hepatitis C virus (HCV) protease inhibitor telaprevir. Data from Phase 3 trials showed that the drug significantly improves sustained virological response rates when combined with pegyalted interferon plus ribavirin.
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SUMMARY: Medivir last week announced interim data from the Phase 2b ASPIRE trial, demonstrating that its investigational once-daily HCV protease inhibitor TMC435 (being developed jointly with Tibotec), when combined with pegyalted interferon plus ribavirin, increased the likelihood that treatment-experienced chronic hepatitis C patients would achieve undetectable HCV viral load at 4, 12, and 24 weeks, compared with standard therapy alone. Rates of undetectable HCV RNA at week 24 ranged from 78% for prior null responders to 94% for prior relapsers.
Added to recently presented data from treatment-naive participants in the PILLAR trial, these findings indicate that TMC435 appears to work well for patients with or without prior treatment failure. Further follow-up is underway to see if viral suppression will be sustained 6 months after completion of therapy (sustained virological response, or SVR).

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