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Replies to #53102 on Biotech Values
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ThomasS

10/02/07 6:50 PM

#53106 RE: DewDiligence #53102

VRTX: "He added that from further analysis of the data, "it is now clear that telaprevir, not ribavirin, was the cause of the rash observed in combination treated patients in PROVE-1.""

---Interesting; my personal experience involved living out of hydrocortisone tubes due to Ribavirin... not to mention the severe ribavirin-induced anemia. They need to separate rashes by drug fractions.
The story remains the same: it would be nice for an improved "treatment," yet, the first effective vaccine will put all of these HCV companies on the ropes. IMO.

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genisi

11/09/07 3:04 AM

#54571 RE: DewDiligence #53102

Here are Dr. Sanjeev Arora, Executive Vice Chair at the Univ. of New Mexico Health Sciences Center and an HCV investigator comments (CIBC hosted a CC with him):
Dr. Arora believes PROVE 1 and 2 demonstrate telaprevir has clear clinically meaningful benefit vs. standard of care, which he believed performed within the expected range. He said the different relapse rates in the 12+12 arms of PROVE 1 and 2 likely relate to selection of pts with RVR in PROVE 1.
He felt that higher SVR rates may be observed in ph.III, as docs have increased experience managing rash and a higher threshold for stopping therapy. He believes that current data supports moving telaprevir into ph.III studies shortly, and that the FDA will require SVR24 as the endpoint.
He emphasized that safety of the earlier-stage PIs remains an open question.