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Re: DewDiligence post# 144553

Thursday, 06/28/2012 5:17:41 AM

Thursday, June 28, 2012 5:17:41 AM

Post# of 257253
First, nice find on the modified language!

Although the 24-week post-therapy time frame is the gold standard everywhere (papers, guidelines, clinical trials endpoints), I've seen a bit broader term such as: "SVR, defined as undetectable levels of HCV RNA at least 24 weeks after completion of therapy" being used (emphasis mine).

The late relapse seen in ABT’s PILOT study might indicate that longer follow-up periods for monitoring late relapse may be needed in IFN free DAA combos, but then I wouldn't read too much into the language in the label of an IFN containing regimen as it could simply reflect the fact that VRTX has more post treatment data they asked to include in Incivek' label.

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