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Gilead GS7977 & Bristol Daclatasvir Phase 3 Trial
Jun 18, 2012

First Dr. McGovern - Thank you for participating in this forum. For many of us in small towns we do not have access to experts in this field and to us this is an invaluable resource. As you probably know - Gilead and Bristol Meyers recently reported a 100% response rate of an all oral regime of GS7977 and BM's daclatasvir. However, Gilead has elected not to continue with BM in Phase 3 trials - opting to try and develop an all Gilead treatment. What is your opinion on this decision and is there anything the medical community can do to pressure Gilead to proceed to Phase 3 with BM. Those interested can sign a petition to Gilead at http://www.change.org/petitions/gilead-sciences-a-phase-iii-collaboration-for-the-treatment-of-hepatitis-c

Response from Dr. McGovern

I am very happy to know that the website is helpful to you - Music to my ears as they say...

You are correct that the combination of GS-7977 (a polymerase inhibitor) plus daclatavir (a NS5A inhibitor) looked spectacular at EASL. The response rates were very high (100% with genotype 1 and ranging from 79-100% with genotypes 2 and 3).

Keep in mind that we still don't know the true outcomes...The earliest timepoint you want to look at for cure is SVR-12...eg, 12 weeks after stopping treatment. The results we have are only SVR-4...Thus, a lot can happen between SVR-4 and SVR-12 in terms of relapse.

So keep tuned as to the results.

The other issue you allude to is having two major pharmaceuticals work together. So far that combination seemed to be a winning one. We can only hope that there are some other advantages of other new combos that will be apparent when we see some of the new data to come....



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