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]

Thanks Susie...Us 1a's have to stick together :-)

Just kidding of course...we all have to stick together in this ugly fight!

[curiouslady1]

In 1991, who knew?

[SusieS2010]

Thanks curiouslady. I'm glad Pharmasset is allowing cirrhotics as well. They have to be pretty certain that the drugs are safe in order for us cirrhotics to be allowed to enter the trials. I also think that we tend to lower the rates of success and wonder if that has an impact on whether to allow us entry. We do mess up those SVR rates.

UKgirl, this is going to sound really weird. I was diagnosed in 1991 and told I was a geno 1b. I believed that until I picked up my records to send to UMass. I was hospitalized in 2008 and I saw they repeated the genotype and it was 1a. My doctor died this year and for some reason his partner retested me and it did come back 1a. So, I guess I am a 1a. I felt like someone stole muy identity. LOL!

[UKgirl55]

Susie, what geno type are you?

[curiouslady1]

I think I get it Susie.  Sounds awesome.  Maybe you could keep a record of your treatment on the tracker and journal it so others might benefit.  I think it is great that Pharmasset is getting on board with offering these oral treatments to people with cirrhosis.  The metabolism is different according to my doctor but it is about time.  I suspect there is a lot of withholding of info with these companies.  They seem to dose the public so as to keep the investors satisfied.  At least that is my take on it.  But I really think that Pharmasset has the IT drug.  

[SusieS2010]

I am in NJ,, however the study is at UMass with Dr, Ray Chung. He is allowing me to have the majority of my labs in NJ and just go to Boston when there is a doc visit. The study is not due to begin for a few months. I do not know if it is the same as the NIH study. All I know is that there is no interferon. There is a 50% chance of placebo for the ribavirin and if those people do not respond they will get the real ribavirin. They are allowing cirrhotics. I think this may be one of the additional arms added to the Quantum study but I am not positive. I haven't had my actual visit yet, they have just seen my records from my doc here in NJ and have said they will accept me. I'm sorry I can't be more help. As soon as I learn more I will certainly share it.

[curiouslady1]

It's amazing isn't it?  I didn't know just how anxious and uptight I had become knowing that I had this curse in my blood for so many years until I saw those numbers.  13 million to 56 in just 7 days on only one drug PSI 7977 with only mild fatigue as a side effect.  I cannot recall when I have felt a more intense sense of well being.  

[Juttutin]

> "my study has a ribavirin arm and when I seemed disappointed to not be in that arm my study coordinator said "Why you want to feel all the side effects that come with the ribaviri?" "

Lol - And I was upset when I found out I was on the no-IFN arm of my trial!  I wanted the best shot at cure, natch.  But that was before I saw what my cohort-mates were gonna go through.  And before I got my day-2 results (on about day 7) 23 mil down to ~300.  About that point I realised I'd totally lucked out!

[Juttutin]

I would say that for most of those on IFN for 4 or 8 weeks, felt that the RBV was a doddle compared to IFN.

Most dealt with RBV just fine.  Being aware that there was a cause for our ****** moods meant we could joke about it.  And I think that humour, and being able to tell family etc that we couldn't help it if the drugs we were taking turned them into moronic idiots, helped a lot).

One lady had the moods real bad (you wouldn't want to be a nurse taking blood from her if you weren't pretty damn good at doing it fairly painlessly...) and she was also one of the ones who had to have her RBV reduced for medical reasons (I think anaemia). Lovely lady though, if you look past the chemically induced raging.

I wouldn't worry about RBV, take it as it comes, if you get anaemic, then I'm sure they'll take care of you, and it seemed easily enough resolved.  A couple of weeks of coping with it is a small tradeoff for clearing the evil bug, and rage just gives you a perfect excuse to tell a few people a few things :-)

I feel great generally.  Still clear through SVR24, having SVR36 bloods taken Friday.

[UKgirl55]

I think I've just answered my question to you. You're a geno 3. The NIH trial is for geno 1's...Maybe they feel that geno 1's need the 24 weeks? What do you think?

[UKgirl55]

I'm possibly being screened for a trial with 7977 and Riba. I'm very nervous about taking the Riba! I'm very petite and drugs hit me hard. Do you know how most people were able to handle it? I just know that anemia will knock me on my butt!! One trial doctor explained to me that it's the IFN that blocks the red blood cells from reproducing and without the IFN the body naturally boosts the red blood cells on it's own, SO the decrease in cells is worse when you're on IFN....does this make sense, or will this be wishful thinking on my part?

How are you feeling and when will you know if you're still UND? Or do you know this now?

Wonder also why the NIH is going for the 24 weeks?

[Juttutin]

I was in Arm-1 of Phase-1 of ELECTRON

( see Page 15 of http://files.shareholder.com/downloads/VRUS/1479878974x0x468444/7eea5a58-1bcc-4b42-a53c-d335b58f3a22/Corp%20Presentation_Nobel_051611_final.pdf )

So just 12 weeks of RBV and 7977 and nothing else.
But others around me in other arms of the trial had to endure 4, 8, or 12 weeks of IFN.  

The study was designed to find out how much IFN was required, or if it could be dropped altogether.  The positive results (data out ~3pm Sunday) means now they're now moving on to trial dropping RBV as well, or to treating for just 8 weeks of 7977+RBV.

[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.

[curiouslady1]

I didn't get back to you.  I think that is positively wonderful.  Can you please post the NCT number of the trial and where you are located?  Puppylvr really would like to get into a study with 7977 for null responders.  You may help her by contacting her directly too.  

[UKgirl55]

Just asked you this question on the other forum page...so here it is again. Did they already open the PSI-7977 and TMC-435 trial? And if they didn't open it already....Isn't it for nulls only?

[Juttutin]

There are good graphics explaining the Phase III PSI trials at

http://files.shareholder.com/downloads/VRUS/1479878974x0x513707/5ed40e14-87f7-4606-9434-31b4a908dfcd/VRUS%20P3%20deck_11111_final.pdf

FISSION is GT 2&3, PSI-7977+RBV or SOC,   250 in each arm, no placebos

POSITRON is GT 2&3, Interferon free, 7977+RBV (150) or placebo (75) arms

NEUTRINO is like POSITRON, Study design still to be finalised, but across genotypes, including (probably) relapsers and non-responders.   7977+RBV (around 210) or placebo (around 70)

Also being discussed are Stage II trials:

ATOMIC - Mainly GT1, also GT4,5,6.  7977+RBV+IFN, testing out 12 vs 24 week treatments, no placebo, 300 patients total.

ELECTRON 2nd Cohort (EXPANDED) (NEW ZEALAND) 7977 MONOtherapy GT 2&3 (10 patients); 7977+IFN+RBV for only EIGHT WEEKS tx GT2&3 (10); 7977+IFN+RBV GT1 non-responders (10)

Graphics for these two can be found in http://files.shareholder.com/downloads/VRUS/1479878974x0x491164/0f22f336-b35d-4c0c-b516-058caa039c4d/Corp%20Presentation_Canaccord_81011.pdf

[UKgirl55]

Is this the NIH trial Susie?

[SusieS2010]

Everyone will get 7977. 50% will get ribavirin with it and 50% will get placebo for ribavirin.

[curiouslady1]

No idea.  But I think it's all good.  But Pharmasset is not just looking at GT 2 and 3.  They have plenty of trials out there for GT1.  I don't think this company has a lot of discretionary money though as it is not big but rather little Pharma so it makes some sense to me that some trials will be run under other auspices, like government entitities etc.  In fact, although I feel that the principal drug in my trial is PSI 7977 (because of its high barrier to resistance), the trial is sponsored by Bristol Myers which has the second drug in my combo (lessee, it has a new name declasovir? BMS 790052).

Is this NIH trial close to where you live UKgirl?