Think 3x day dosing outside of a clinical setting may impact dropouts more.
Notes from call thus far (but I have an app. at 10:30) Please execuse spelling/typos/grammar/etc.
Like VX-950 think market cap of over 5 billion ahead of itself. Market reacting to drop outs
RVR (Negative at week 4) – Very strong positive predictive value for SVR
Week 4 not just increasing pool of potential relapse but those who will go on to get positive value. Disappointed didn’t see week 4 data, presumable have it for more patients then week 12 data.
Skin reactions and discontinuations of some concern. 9% after 12 weeks little higher. Perhaps more serious rash of concern. Raise the concern that > 12 week prohibitive.
Ribavirin with VX-950 and relation to anemia? Majority effimacis on rash and GI upset. Nothing suggests interaction between 950 and ribavirin directly regarding anemia.
Polymerase GI tox vs. Protease GI tox. Think there will be dose related GI tox with these compounds. Both Idenix and Roche PM’s GI side-effects occurring and dose related and some case may occur prior to significant inhibition of viral replication. Think similar situation will occur with PI’s but serious not reported (severe nausea vomiting, pancreatisis). Ribavirin known to aggravate these side effects so concern when this is added.
Risk of skin rash? Discontinuation due to skin worrisome because with PEG/Ribavirin don’t generally lead to this. Maybe 950 aggregate PEG/Ribavirin and not directly causing it.
Probability on filing based on PROOVE this data increase or decreases probability? Doesn’t change it having expected very low to begin with.
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