Like many of you I too have gone through the gut wrenching experience of watching VRTX lose ~50% of its share price on the premise the new all oral competitors are eating our lunch. I have read this board with great interest and decided I would like to add some of my own thoughts.
Clearly the biggest catalyst this quarter will be the all oral data. It got me thinking how much of a drop in undetectable HCV would we see once INF is removed from the mix. You will recall the TVR (1125mg) + 222 therapy (400mg) gave a 59% drop in HCV by week 4 but also had ~31% viral breakthrough. The upper limit was established with last year's quad results of 90% (so we won't expect it to be better than that). So the burning question is how good will TVR + 222 + RBV be? And TVR + SOC already gives around 75% cure rates so ...
TVR + 222 = 59% (by week 4) TVR + 222 + SOC = ~90% TVR + SOC = ~75% (give or take a few points) TVR + 222 + RBV = ???
Of course, no VRTX discussion would be complete without taking a look at its competitors. To be fair, while I am a VRTX long, there are a few things that have me concerned:
1. IF the VRTX all oral is good (which I am arbitrarily defining as >85% SVR at 12 weeks), that is still a lot of pills to be taking. Fine it is BID, but patients will be taking 3x TVR, 1x222, and at least one RBV (all I know is it's at least 1000mg). So let's say a minimum of 10 pills/day. Put in perspective, the 7977 is a 400mg QD + RBV (2-3 pills max).
2. On the subject of VRUS, 7977 had 100% efficacy against GT-2 (if I remember correctly)
3. To followup with the VRTX all oral SVR discussion above, what SVR would be considered competitive given what 7977 has demonstrated (I realize this is not in GT-1 phenotype)
And here is a closing thought: when will we see this data? Well, if the all oral arms were fully enrolled by the AASLD presentation, VRTX could theoretically have the 12 week data in hand by next week.
I hope the usual suspects of third, glad, and qdelfan can offer their insights.
What puzzles me about Gilead's ubsurd acquisition of VRUS is why there is no public critisis in the radio, web, or newspaper? It does not take a rocket scientist to see that VRUS does not deserve 10B at all. Are all the analysts corrupt, or we missed something?
If VRUS can not show that without IFN, their drug can beat Incivek for Genotype 1 patients, why Gilead spent so much money on VRUS? Does Gilead know more than we do?
I would agree the most optimistic expectations for arms E and F in the Vertex Zenith trial will likely eventually show SVR 24 somewhere between 79% seen in the current treatment paradigm of Incivek + SOC and the "quad" therapy results which I recall as exceeding 90%. The timing of the first interim data IMO will be announced most likely at the time for the fourth quarter earnings conference call on Feb. 2, just as Jeff Leiden officially assumes the duty of CEO. In his remarks on this data at JP Morgan's healthcare conference this week, he mentioned that EOT data on arms E and F would first be released with subsequent "SVR 4" data to be releaased when available lster this quarter.
Remember, it's been mentioned several times to date that no viral breakthrough has been reported on these arms of Zenith through 2011. With regard to comparing the perfect cure rates of Pharmasett's nuc + riba in GT 2 patients reported at AASLD last November, to this all oral Vertex regimen treating GT 1 patients... that's like comparing treating cure rates for the easiest to cure lymphoma with the most difficult to treat lymphoma. It's not a reasonable assumption to make that a treatment regimen for an easier to treat form of hep C will get the same high SVR 24 rates in the most difficult to treat sub populations with hep C including GT 1A and 1B, African Americans, HIV coinfected, post transplant etc. If the interim data to be announced in arms E and F of the Zenith trial exceeds expectaions, it will be first all 0ral regimen in GT 1 patients to have promise and that will likely be a huge catayst for Incivek and VX 222 to move into Phase 3 trials as the first all oral treatment for treatment naive GT 1 patients. I would not worry too much about the number of pills and consider more the improvved toleralbility of the regimen i.e. fewer drop outs due to less frequent or less severe incidence of rash etc., which may further enchance cure rates if most all patients can finish treatment. Q