before Trin's hasty departure(s) she wisely pointed out that I'm on tx and not making sense so take the following with a grain of salt. If anyone can show me where I'm making a mistake I'll be grateful - so far it looks to me as if Merck should be taking poker lessons from Vertex's Bob Kaufman.
First there's the issue of how he convinced the street tela response among naives was 79% when vertex's own data indicates at least 5% less, but never mind that.
An unanswered question that's been rattling around here for a while is what happened to the 118 pts in ILLUMINATE who did not make the eRVR cutoff (und at w4 and w12). When miked asked for questions before the ambassador intro I suggested that one but apparently discussion never reached analysis of the trial data. l. However now that the 147 page Vertex submission is available on the fda site:
we should finally have an answer.
ILLUMINATE is now labeled Study 111 in the FDA docs. A description of the study, its design etc. starts on page 69. The 118 pts who did not make eRVR were assigned to 12+48 and labeled "eRVR-". There was no control arm hence no control SVR stats. Figure 17 tells us the overall ILLUMINATE SVR rate was 74%, confirmed in the FDA review, and then goes on to justify why 24 is not inferior to 48 among the eRVRs.
However, it seems that at no point is the SVR statistic for the eRVR- subgroup ever given. Tables 18 and 19 tell us many details about them (genotype, fibrosis, race, etc.) but never answer the main question.
The FDA review includes the statement :"Of the 40% of subjects not achieving eRVR and assigned to receive T12/PR48, about 64% achieved SVR." but there doesn't seem to be any source for that statement in the Vertex submission. Anyone see it?
If you look carefully, the 2nd column of numbers under the 12+48 "eRVR-" shows that 8 out of 10 low VL were SVR; 70 of the 108 high VL were SVR (65%). Total SVR from that group of 118 was 78 (66%). Maybe the FDA is just lousy at math...?
many thanks for spotting that - Trin was obviously right. Table 19, on page 74, gives the answer. Hidden in plain view - Vertex must have been thinking we'd all enjoy an Easter egg hunt!
That 66%is likely to be important to many (about 40%) of naives starting triple tx : you get to w4 and are not und: do you push on? After 8 more weeks of selecting PI-resistant virions if you don't make SVR chances are you'll have a high proportion of them .
The FDA review did say, 'about 64%' so they're still right. Actually for all the grousing about incompetent government that review, IMO, was a great example of effective government service.
yes, an overall 74% SVR rate for ILLUMINATE has been reported all along. However what Vertex never reported, and appears to have made less than glaringly obvious here, is what happened to the eRVR- subset - those who didn't go und by w4 and stay und at w12 (not a small group) among them, 78 of 118, 66%, got SVR.
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