Pharmasset trial

[linda880]

Is anyone here in the trials by pharmasset?  The drug name is psi-797?    I have a chance to get in the new quantrum trial that was initiated and there is no interferon.  I am gt1 vl 4mil.

[Upbeat]

Here is a email I received from Pharmasset today



There will be approximately 100 sites globally (about 65 in the US).  We will update this web page as the sites become available for enrolling patients

[curiouslady1]

Great!  Thanks Gonnab.  I guess they have to revise it to add more sites.  They have gotta do this in more places than SF and Austin esp. since they said "international".  

[gonnabhepcfree]

Is this the trial..
Pharmasset
ClinicalTrials.gov Identifier:
NCT01435044
this trial that is recruiting 450 people is at www.clinicaltrials.gov and both PSI drugs are having amazing results and one of them has been FAST tracked.,.good luck which every study you get into..

[curiouslady1]

Another question to ask as you look over the consent form is what are the "real" drugs available to the placebo arm after six months?  Are they the study drugs or "rescue" drugs (i.e. ribaviron and interferon) or a combination of the two?

[curiouslady1]

Thanks for the information Linda.  On behalf of other forum members . . . do you have any idea where else beside Florida they will recruit?  The lead info says "international"? Are they giving you any idea of who will be screened out or in?  For example, it appears they will accept people with severe fibrosis and cirrhosis but they have to be treatment naive.  Is this correct?  Do you know if there is a BMI limit? a restriction on other maladies? surgeries etc. ?

[linda880]

I was told there will be 9 arms w/four different combos. Each arm will
be 12 and 24 weeks.  There will also be an arm with a placebo.  Hope
I don't get randomized into that arm! If so, the clinic nurse told me you
will be redirected after 24 weeks into a real arm with real drugs.
The combos are

psi-938  monotherapy
psi938 and psi 7977
psi 7977 and riboviran
psi 7977, psi938, and riboviran

24 weeks placebo
Suppose to start mid october, if i pass screening.  No interferon!!!!!!!!!

[gonnabhepcfree]

I am geno 3A and I am located in San Diego.  My study site is no  longer recruiting for this trial -however there is another site here in San Diego that still is.  The study I was referring to is only takine genotypes 1b-Naive...

[Hopinghepster]

Thanks so much for the tip. I'll check it out.

[curiouslady1]

Dear Hoping,  Adamben101 would have something to say about this.  He didn't do Pharmasset but he is doing an all oral and was in the Riba arm.  I think he has indicated it wasnt' so bad.  

[Hopinghepster]

Yesterday the internet had numerous versions of a press release describing the coming Quantum clinical trial with Pharmasset's two nucleotide antivirals PSI-7997, which everyone here loves, and PSI-938, both fast tracked by the FDA. The trial will use 450 patients with all genotypes of HCV, with and without cirrhosis, for both 12 and 24 week treatments, with and without Ribavirin. If you google the two PSI numbers you'll find the info. They're supposed to be startimg screening now. For those of us who missed psi/bms this may be our best bet. I'd love to hear from someone doing all oral treatment that includes ribavirin. With this new trial you have a 40 or 50% chance of getting Ribavirin and I'd like to know likely side effects, without interferon.

[linda880]

What clinic are you at?  I am in florida.  If you don't mind me asking, do they give you vl results during the treatment?  Also, what GT are you

[curiouslady1]

Wonderful!!~! There are a number of people on this forum who are interested in that study.  Please give details.  It apparently is not listed on clinicaltrials.gov. Gonnab is correct.  There are at least 3 of us that have had Early Viral Response in a PSI 7977 trial and one or two on the HCVsupport forum.  I just received info that I was UND between Day 11 and Day 14 (see my journal/blog for further info).  Again, please tell the forum what you know Linda and any information that could help others who might be interested.  

[gonnabhepcfree]

there are several of us in an all oral trial here on this forum with psi 7977 and bms 790052..I cleared the virus in seven days..PSI 7977 everyone in the study i am in is having amazing results..search either all oral or the study drug. Or just google the name of the drugs..