Replies to post #74846 on Biotech Values

[DewDiligence]

Re: Role of interferon in HCV combination therapy

The thesis I am interested in is whether IFN is likely to have a place in the HCV universe after anti-virals become SoC. I have previous supposed that there was a good chance of a very high relapse rate if an immune modulator does not follow direct anti-virals. With this data I would now state that thesis with more confidence - making it a predict.

I respectfully disagree.

When a treatment regimen includes only one direct-antiviral agent, as in VRTX’s PROVE-3 study, the role of interferon and ribavirin in mopping up mutations to the single antiviral is obvious and unquestioned.

However, when a cocktail includes multiple* antiviral drugs with complimentary resistance profiles, the need for interferon or another immunomodulator is far from clear.

*The optimal number will likely be three, as in HIV therapy.

[DewDiligence]

VRTX ZGEN etc. re role of interferon in HCV combination therapy:

With this data [from the Telaprevir PROVE-3 study], I would now state that thesis with more confidence - making it a predict.

Clark, do you care to retract this statement in light of today’s thread on the iVillage ZGEN board? I’m not being sarcastic and the question is straight-up, not rhetorical.

Further to the discussion of the PROVE-3 data (#msg-36464842), there is more to say beyond today’s thread on the ZGEN board. That PROVE-3 lacked a Telaprevir monotherapy arm or monotherapy portion of an arm is not in any way irregular; rather, it is consistent with the FDA's general policy toward HCV drug candidates. You are not apt to see an FDA-sanctioned HCV trial in which patients receive any kind of monotherapy for a period as long as 12 weeks inasmuch as such a trial design would be unethical.

I would immodestly suggest that you reread #msg-36466697 and do a little more homework before you make further predictions regarding the HCV arena. Regards, Dew