Note: MRK’s PR today presents the HCV data on a per-protocol basis rather than an ITT basis; i.e., MRK’s calculation of the SVR12 rates in various cohorts excludes patients who dropped out.
This is not to say that MRK’s data aren’t excellent—they are; however, PP data have an upward bias relative to ITT data, and this should be taken into account when comparing MRK’s results to those of other studies.
Their Japan regimen is now on file out there and it shows good SVR but this is only good for GT1b (87% SVR in IFN intolerant and 81% SVR in prior non-responders
I'm hoping BMY can do well in japan despite SVR rates that seem on the surface to be a bit lower than those being reported in earlier stage trials for competing all oral regimens. First off these patients are somewhat harder to treat. even the interferon intolerant/ineligible patients (naives) tend to be older and more frail. Also I get the sense there must be a lot of demand for an all oral regimen and waiting another year for a combo that might yield another 5% in efficacy isn't going to make or break treatment decisions (I base this on the fact that telaprevir didn't sell well at all in japan* - presumably because the demographic is swayed towards older pts who can't take interferon and/or rib - which is one of the reasons why I don't think simeprevir will do all that well in japan despite it's early introduction relative to other follow on DAAs bc it is paried with I/R unless it gets significant off label use)
*sales were <100M for all of 2012, the first full year after telaprevir approval in japan