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Replies to #75477 on Biotech Values
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DewDiligence

04/04/09 4:10 PM

#75497 RE: mcbio #75477

Re: VRUS / future of HCV combination therapy

in general, at what point have prior HCV compounds across all the classes run into safety problems? Is it generally at the 7, 14, 28-day mark, or some other point? Also, I'd assume that the safety concerns have generally arisen in Phase I or Phase II trials, but are there prior HCV compounds that have made it into Phase III before the first sign of safety issues appeared?

Most toxicity issues show up in phase-2 when a new drug is combined with other treatments and is tested for 4 weeks or longer.

Are you saying that investors haven't necessarily subscribed to the theory of the need for multiple direct-acting antivirals in conjunction with interferon and ribavirin?

Investors have not yet subscribed to the idea of multiple direct antivirals in the same cocktail—either with the current SoC or without it.

how soon do you think an all-in-one pill consisting of multiple direct-acting HCV antivirals will be the norm?

Good question. My wild guess is that such a product will be on the market in the next 5-6 years and that it will quickly take market share from everything else, just as Atripla did in HIV.