More all-oral research .including genotypes 1,2 and 3.

[willbb]

Pharmasett anounces three new Inf. free Phase III trials for all geno types:

http://investor.pharmasset.com/releasedetail.cfm?ReleaseID=619564

[UKgirl55]

What trial were you on Jut? 7977, Riba and what?

[curiouslady1]

Gee I take 7977 and never had a taste problem.  As far as enrollment, Michigan57 mentione it in her profile.

[Juttutin]

I might well be wrong about QUANTUM enrolment. Thought I'd read something, but tbh I couldn't find it again, which is where the "(I think)" came in.  Folk should probably disregard that.

I don't remember anyone talking about rashes at all.  I think there may have been some anaemia.  There were def others who had their RBV reduced due to AE, but I don't know or remember 100% why.

My trial was Open Label - which was great - we were allowed to look at our graphs etc - except suddenly between SVR12 and SVR24 it was withheld; I vaguely wondered if me spouting here had been a thorn in some info release strategy.

Talking side effects, it's worth mentioning to those heading to 7977 that it seemed that for a subset of us, the tablets tasted absolutely horrible.  No one warned me about that, and I almost threw up a few times if I didn't get it down on first gulp.  Most of the others had far less, or no,  'flavour' issues with it.

I think some of those around me suffered more than me from RBV related effects, I didn't find it so bad myself, and I managed to avoid actually punching anyone.

[curiouslady1]

Jut- How could Quantum be finished enrolling so quick?  They just got started.  Doesn't make sense to me.  

[curiouslady1]

I like the NIH study too.  If I were close and wasn't doing the one I am on I think I would go for that one.  Another advantage is that it seems to be open label so you can get your results all along.  I am not intimidated by Ribavirin as I am with interferon.  I figure it can't be all that bad without its sidekicks interferon and telaprevir.  Do you now anyone who got rashes?  severe anemia? like they are claiming elsewhere on the forum Jut?  Just curious.  Irritability?  Ahhh.  Piece of cake I'd say.  

[Juttutin]

Of course there is also QUANTUM, comparing, combining 7977 with 938 and placebo across 450(?) patients, no interferon, all genotypes.  Enrolment is (I think) mostly complete.

http://files.shareholder.com/downloads/VRUS/1479878974x0x501016/559fb290-7e4e-4297-9e56-5daa79b0793f/Corp%20Presentation_UBS_91511_2.pdf


And, after some hunting, this NIAID (Part of NIH) Trial mentioned above, not being sponsored by PharmAsset. NIH 11-I-0258, Clinicaltrials.gov NCT01441180.

GT1, loads of exclusions but not the normal ones like prior treatment as far as I can see. (80 patients)

http://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2011-I-0258.html
http://www.clinicaltrials.gov/ct2/show/NCT01441180?term=PSI-7977&rank=7

I guess it's good to have a totally independent-from-Pharmasset government sponsored trial to provide validation.  I'm intrigued by their decision to treat for 24 weeks, but all good.