I'm posting to you here so I'm sure you will see this. I am not sure what your acronym means (DAVP). Are you talking about expanded access? I have the slides from Dr, Pokros. They may shed some more light on his debriefing. I read the debriefing document and glanced at the slides. I think there is a lot more info in the slides. If you message me your email addy I will send them to you.
I'm not as down on the idea of a no interferon regimine as you are. Adding a polymerase to some protease makes sense to me since I've heard what some of the researches had to say about why that should work. Of course I could never explain it to someone else. LOL. I guess time will tell.
thanks - I will pm you an address. I saw somewhere that Pockros' slides would be made generally available but as far as I can tell that has not happened yet. DAVP is the Division of Antiviral Products within the FDA. This is the office, headed by Drs. Debra Birnkrant and Jefferey Murray , that sponsored a hearing last April on expanding access to Direct Acting Antivirals (DAAs) for those with unmet medical needs (null responders, hemophiliacs, hiv/hcv coinfected, recent graft recipients, etc.). As far as I can tell this initiative is THE ONLY route that will give those patients access to currently available drugs, particularly multi-vendor combos, within the next 5-7 years. Eventually all viable drugs will be approved but that's a very slow process.
I'm not down on multi-DAA combos (eg protease/polymerase inhibitors) at all - quite the opposite. After I relapsed from my last tx 7 years ago I thought that was the best strategy, but I obviously underestimated the delays involved. What I am down on is the FDA's inability to move that DAVP initiative along and failure of the "hcv community" to exercise any pressure on them. The actual process of drug approval is necessarily slow and meticulous. But experience with HIV shows you don't really need to kill off many in need in the interim.
The trouble with the current two DAA trials is that only drugs from the same manufacturer are getting tested - so best-in class combos from different manufacturers remain completely unexplored.
You may want to take a look at results from an ifn-free polymerase/protease trial presented at AASLD'10 by BI. (abstract LB-7). Full poster here:
"PegIFN sparing treatment with the the NS3/4A inhibitor BI 201335, NS5B inhibitor BI 207127, and RBV, demonstrated strong early antiviral activity against HCV genotype 1 with good safety and tolerability. A phase IIb trial testing different dose regimens of this combination, with longer durations, is planned to evaluate sustained virologic response rates. "
Ohhhh, now I understand what you are saying. Thanks for all the education here. I will look more carfully at that BI study. I only scanned it before for the very reasons you state....it's going to be a long while.
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