hepdart paper - data analysis, page-4

I think you are misinterpreting the trial data as to the drug's efficacy in HCV. This was not phase III data so is not comparable to that acquired in a phase III trial - the statistical significance is much less due to underpowering. This is demonstrated by the cEVR rates in the PEG-IFN/Riba (placebo) arm which are higher than would normally be expected, therefore the active (BIT225) arm will have a higher cEVR result than would be obtained in a larger, broader-based sample. The reason for this is the population that the trial occurred in was Thai who have a higher incidence of a favourable IL-28B genotype, and therefore always respond relatively well to HCV treatment. In actuality, there is no difference to the results with telaprevir which were a 50% improvement in SVR.

In response to another poster amazed at what Gilead paid, you underestimate the impact of Prof Gane's presentation at AASLD in San Francisco in November. The fact that Pharmasset's polymerase inhibitor CURED patients with ribavirin alone was unprecedented and completely unexpected. The holy grail of interferon-free regimens for HCV was though to be a decade away, and here was a very basic regimen that may do it now. The polymerase inhibitor was also found to be very resistant to mutation. I'm betting that Gilead saw the new tenofovir in this study - this drug (owned by Gilead) has revolutionised HBV treatment and to a somewhat lesser extent HIV. With tenofovir, a single highly potent drug with a high barrier to resistance can treat HBV longterm with no side effects, again a complete change to the prevailing dogma only 2-3 years before. Gilead will be running with PSI-7977 into phase III very quickly in order to gain primacy advantage, and if this drug works on geno 1 as well, then the door is going to shut on a lot of other promising agents.

So Gilead saw a potential game-changer and paid generously for it. There is certainly nothing yet remotely similar with BIT225 - it is certainly not a game-changer in HCV, though might become a useful adjunct in future, and its role in HIV is yet to be demonstrated. As someone has noted here, at $16 million it could become an opportunistic pick-up, but you are likely to need a lot more data to justify such a move.