Here's Pharmasset's problem: How can we market an inferior drug regimen for treatment of GT1 Hep C when we have already seen how miserably Merck's inferior Victrelis has failed against Vertex's superior Incivek? Solution: Get a label for the all-oral PSI-7977/ribavirin from FDA that somehow includes some GT1 patients. The Neutrino study is designed to show GT1 Hep C patients that cannot tolerate interferon achieve some cure rate greater than placebo. Next, when you get that label from the FDA that includes treatment of GT1 Hep C patients intolerant of interferon, you market PSI-7977/ribavirin to everyone with Hep C in the U.S. saying it is the only all-oral treatment for all Hep C patients. Of course, you need to make the numbers look good so use the Neutrino results which include the confounding variable of GT2/3 Hep C patients mixed in with the GT1 Hep C patients. In the U.S., GT1 Hep C represents about 75% of patients with the remaining 25% being GT2/3 Hep C. The easier to cure GT2/3 Hep C patients should have nearly a 100% cure rate with PSI-7977/ribavirin. For the GT 1 patients, if the cure rate were to match the Victrelis regimen at 66% (a great achievement but still far behind the 79% cure rate of the Incivek regimen), the numbers could then be combined with the 100% cure rate for GT2/3 Hep C patients and yield an overall cure rate of 75% across genotypes 1, 2 and 3. The marketing message will go like this: Pharmassett has the first all-oral Hep C regimen with a 75% cure rate across all genotypes commonly seen in the U.S. Of course, there will be a footnote in fine print stating that with respect to GT1 Hep C patients, PSI-7977/ribavirin is only indicated in those that cannot tolerate interferon. But, of course, no one wants to take interferon if they do not have to, so Pharmasset's message will be that everyone should be treated with PSI-7977/ribavirin.
A footnote in the fine print? *What* fine print are you referring to?
The above is the kind of delusional rant one often sees on Yahoo and on this board in particular. A few years ago, people here were posting that SGP was lying to investors about the phase-2 Victrelis data. Now, VRUS has supplanted MRK/SGP as the perceived archenemy, but the mindset remains the same, evidently.
SGP WAS fudging on Victrelis trial data. Right now VRUS is less than complete with the data they are releasing and it brings about suspicion. It may well turn out that VRVS has just what they claim to have. They are riding the wave of success, and VRTX has taken a big hit as a result. With more complete data VRUS could be the one taking the hit and VRTX could regain darling status. We'll just have to wait and see. At the very least, I'll give VRUS credit for making a great stride in the science of treating Hep C.
Doctors and patients(I have genotype 1)will choose the course of treatment that gives the highest probabilty of eradicating the virus. They can hype it any way they want but cure rates are the only numbers that count. For example, the liver specialist I have been consulting with worked on the Merck trials for Victrellis and was initially pro Victrellis,but now,with no hesitation, says take Incivek. The numbers are really the only thing that matters.
It's a great marketing plan. Those madmen at Pharmasset have come up with something really special here. The only way to improve it would be to market it directly to the public, which they probably would. I can imagine it would go something like this: "Have you been wanting to treat your hepatitis C but were afraid of all those injections? Ask your doctor if Pharmasset's new injection free hepatitis C treatment is right for you.". The only problem is the prescribers of these Hep C meds are among the most knowledgeable, informed and academic physicians out there. Not many were fooled by Merck's Victrelis and I expect they will not fall for Pharmasset's tricks.