Wednesday, December 13, 2006 5:28:26 PM
The VRTX phase-2 trials seemed very well-planned and comprehensive when they were first unveiled , but I bet they'd like a do-over about now. The earlier trials with 2-wk and 4-wk durations of VX-950 plus pegifn +/- riba , followed by SOC , may be closer to optimum than 3 months of triple therapy. They do have an arm in Prove-2 using 950 plus pegifn (no riba) that may end up working as well as the triple therapy and could provide valuable insights for the P3 trial design.
Maybe the increased severity of rash and other SEs resulted in reduced treatment compliance and , therefore , efficacy. Ironically the SEs may be largely due to immune mechanisms that could beneficially contribute to SVR , but if the patient drops out you never find out if this is true.
I wonder if the '9% discontinued' means they are also lost to follow-up , or did some go on SOC and could still contribute to SVR rates , assuming they received at least some VX-950 tx.
If not it means the absolute upper limit on SVR is 91% , and that assumes no more dropouts and 100% SVR rates for the rest , which ain't gonna happen.
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