Vertex Phase 3 Start Jan/Feb?

Just returned from my Prove 1 48 weeks post-tx follow-up, which was the FINAL step in the trial. I'm now officially finished.

The staff were excited to tell me that they were starting Phase 3 in a month or so. The final trial design is, or is very close, to FDA approval. They anticipate enrolling the initial cohort of naive subjects in January, to be followed by a second cohort of non-responders a little after that. No details on the specifics of trial design except that all non-control arms will be triple therapy. There will be no non-Riba arms, which should be good news for prospective subjects.

Anyone who wants to get into the Phase 3 trials should be contacting their local clinics now. Given the much larger Phase 3 cohort, its likely that there were be more clinics involved that was the case with Prove 1 and 2, but the clinics that participated in these earlier trials are the best place to start. If your local clinic is fully booked, its likely that they will know of other clinics who are running Phase 3 groups, given that they have al been to initial conferences on Phase 3 already.

Full disclosure: I was a geno 1B with a VL of 24,000,000 and Stage3 liver histology, enrolled in the 12+12 arm of Prove1. UND around day15, and SVR at 36 weeks post-tx. I'll soon know the 48 weeks post-tx, but there's no reason to suspect its not still SVR. I'm fully recovered from the rigors of the tx, and feeling better than I've felt in many, many years. I wish the same for all of you potential Phase 3 lab rats :-)

[miked]

Congrats on finishing 48 weeks!  You should be getting your results within the next 2-3 weeks (at least I did in Prove 3).  Please let us know what they are.

Did you receive Ribavirin?

miked

[APKhaos]

Should have the PCR results in 7-10 days,which has been the typical time at this clinic.
Yes, my arm was 12 weeks of VX + SOC [inc Riba] & 12 weeks of SOC [inc Riba].

[denzelbrown]

wow,

thats great news,

i hope they start the phase III soon, any news any one?

[APKhaos]

Did you read the first post in this thread?

[roostermom]

my daughter might be starting in a vertex trial through cornell. How were the side effects - same as combo tx? I heard the tx is shorter, but you went for 48 wks?

[APKhaos]

No, my tx in the Prove 1 trial was 12 weeks of telapravir and SOC sollowed by 12 weeks of SOC alone. Its now 48 weeks since I finished treatment, which may have been confusing.

This was the first time I'd treated, so I can't really give you a first hand comparison, but the sx seemsed to be consistent with what you read about SOC sides. I had a nasty rash and related itching, but that resolved quickly with topical steroids. Some Prove 1 subjects had a truly nasty rash, which caused a number of them to drop out. The published data says around 13% dropped out due to unmanageable sides vs around 9% on SOC.

I suspect that a large number of the Phase 3 subjets will we on the same 12 + 12 dosing regimen as described above. There may be a shorter arm, and although its possible that there may eb a longer [48 weekdosing] arm, its unlikely given that the results from the Phase 2 trials seem to show that the 12+12 regimen is the sweet spot. The Phase 3 trial design should be published soon, and then we'll all know the facts. Best wishes for a speedy SVR for your daughter.

[roostermom]

Thank you.

[susan400]

Hopefully, they will change their protocol to allow rescue drugs!    Susan400