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Trial Information All Oral PSI 7977 and PSI 938

Some people have asked me about this study and I will post information also in my journal as I receive it.  I spoke with the study coordinator from Pharmasset and she advised me that screening will start on September 26 at the two sites posted.  There will also be plenty of opportunity throughout the US and some in Europe but the IRBs (institutional review boards and local regulatory agencies) have to approve the study design etc. and so the enrollment will be staggered.  As new sites are approved locally they will be posted at clinicaltrials.gov/  The two listed are the only ones whose own IRBs have approved the study so far.  But they do not represent the total sites by a long shot.  She said Pharmasset and Quinteles are attempting to hit most or all major cities and a very many states.  She cannot tell me which ones as it all is pending approval.  If you are interested in this opportunity please keep checking the web site for updates over the next few weeks and months.  Once enrollment is open at the site listed, things will move fast and opportunity can close just as quickly.  The details of the study have already been posted as NCT01435044.  
23 Responses
Avatar universal
CL, thanks so much for making that call to Pharmasset. It's very good to have direct information from them. An examination of the data from trials with these two drugs shows that they have had phenomenal rates of success, with and without SOC. They truly represent the leading edge of hep c research. There are risks, of course, but tthere is also great promise!
Avatar universal
I have nothing but praise for Pharmasset to be running this trial which pushes the boundaries of hepC tx and may very well result in a successful all-oral tx for all.

However, I would personally not do this trial unless death were my only alternative.  Some of the arms are so risky, IMHO, that they are off the scale of risk in terms of failure to reach SVR.  This one is strictly for gamblers and those who feel lucky, IMHO.  

On the other hand, collateral damage is likely to be small.  So people who fail and end up with resistance to one DAA should still hopefully (but not guaranteed) have options to treat again later with something else.  

dointime        
Avatar universal
Of course, the scientists, the institutional review boards and the FDA know much less than you do dointime and that is why they are supporting this study.  There is some risk involved in all research but the known risks of SOC in the view of many outweigh any of the risks involved in these studies.  There is already data of SVR with these drugs combined with peg and riba which far outshine anything out there on the market with SVRs close to 100% and no or few drop outs due to AE because there is little or no potentiating effect on the sides as there is with what is on the market.  FDA and drug companies do not allow trials to move forward just because.  The agency has to have some very good idea that these drugs will work.  
Avatar universal
vioxx??? FDA approved...killed thousands...happens
Avatar universal
Yes, that was in 2003/4 and hopefully we have all learned something.  Otherwise, we had better go back to treating ifn only or maybe not treating at all since we know that won't work for many of us.  Like I always say and I'll say it again, the HepC patient's worst enemy is anxiety and fear.  
Avatar universal
I for one would never advise anyone to treat in a trial based on unsubstantiated data, particularly with genotype 1.  Let's hope that the 86 - 92% of those who attain eRVR and go on to SVR with the current DAA's can rejoice in their success along with curiouslady1 who apparently knows more about the odds of a durable SVR with the all orals than we do.

179856 tn?1333547362
Nah, the hepc patients worse enemy is the hepc itself and for many of us, the fear of dying and anxiety of liver failure were much higher than the fear of interferon. At least for anyone with any common sense.
Avatar universal
Up to 94% with INF peg and a P.I  ......As Hector so succinctly  stated...never been a better time to treat!
Avatar universal
Lynda I am not sure why you feel in the position to advise anyone to treat at all.  People often want to be given alternatives to harsh treatments.  From the looks of it, you and dointime are taking on as if I was posting about taking supplements when nothing could be futher from the truth.  The people running these studies are scientists and have gone about the steps of the research in the standard way.  There is nothing illegitimate about posting information so that people can find their way to these trials if they are eligible for them.  Of course, it is not a sure thing.  These are research trials.  There are many things that could go wrong.  The trial could be pulled right in the middle and leave everyone stranded.  Some horrible effect that was not at first evident could surface.  Everyone with RVR could have breakthroughs  a month after they stop dosing.  These possibilities and more are clear for any research.  Yet advance information suggests that these drugs (and probably others) that are just now being researched are the wave of the future and will make life a lot easier for many.  I don't think people should be purposely steered away from considering these options.  They can decide for themselves once they look at all the information at hand.  If they don't know about such opportunities than they have no choice at all.    
Avatar universal
I advise no one and have provided accurate, published information regarding triple therapy success.  How one chooses to move forward is their decision, not mine.  I have maintained all along it's is up to the individual and their physican and many factors need to be considered.  
However, the opportunity to be cured with much higher odds is out there now for genotype 1 and people should be made aware it.  The trial results speak for themselves, it is not speculative data.
Avatar universal
Hi, Do you know anyone who has treated with these Pharmasset drugs and what the sx were? Just came back a few days ago, been away for a while. I heard about these new dugs are being tested and was considering them in a clinical trial. Any suggestions?

                                                                                   Bob
Avatar universal
My post was not in any way intended as a personal attack on you, or intended to imply that you shouldn't have posted.  I like your posts and hope that you continue to post.

Early indications are that the Pharmasset drugs do have high efficacy, high barrier to resistance, and low side effects.  On this we agree.

I think where you might be a little bit naive is about how these trials are designed.  Drugs companies need to prove to the FDA that they are not overprescribing their drugs for financial gain.  So if they recommend, for example, to take the drug for 6 months then the first thing they will be asked is to prove that the same result couldn't be achieved in 3 months.  In this way they have to run the arms of the trials not just close to the edge but over the edge, to find out where the edge is between success and failure.  It is not that they want people to fail, but it has to happen for them to confidently prove to the FDA that they are recommending the minimum dosing for approval.  So if all the arms in this trial achieved 100% SVR it would be fantastic for us but they'd then have to run a whole new set of trials cutting down on dosing until people did start to fail.

My hope for this trial and indeed any trial is that the failures are enough to prove the minimum dosing but not a huge number of people.  I do not want to see massive numbers of failures.  Pharmasset are smart guys who  know the risk and I am sure that they will be standing by to pull whole arms if they demonstrate in early testing too high a failure rate.

dointime                
Avatar universal
Massive organizations like the FDA are often monstrous and have their own perversities.  Here is a good example:  http://vimeo.com/26874089 Consumers can be a force for change by simply refusing to sit still for standard of care regimens that are hurtful and forbidding and pushing for more efficacious and benign treatments for diseases and infections.  By this time we should have come up with a penicillin-like alternative for treating virus.  It is long overdue.  If not these drugs, than others which are equally as effective and safe should be promoted.  We as consumers need to push for what we want or, quite possibly, we will never get it.  
Avatar universal
"Hi, Do you know anyone who has treated with these Pharmasset drugs and what the sx were?"

I am currently participating in Atomic trial with PSI-7977, Peg and Riba.  After 3 weeks, my experience has been some sx from the peg and riba, but none from the PSI-7977

'
Avatar universal
BTW, after 2 weeks on the meds, I am undetectable. Went from 10 million viral load to 17 (week 1) to undetectable (week 2).
Avatar universal
I'm having a little trouble finding any info on this study. Can anyone tell me where the 2 locations are for it?
Avatar universal
Great!  I had UND at either Day 12 or 13 with 7977 for 7 days and then BMS 790052 added on Day 8 no peg.  The other study people I know including one who treated for three months with 7977 and peg and riba for 18 days and she went UND after a week (GT 2 or 3) and four others on the PSI/BMS all oral combo with two having UND within the first two weeks, one within the month and 1 who is just starting had a 4 log drop in 72 hours with 7977 alone.  Those of us who had the 7977 lead in have noticed only mild fatigue during that time.  I am trying to put everything I find out in my journal.
Avatar universal
Hi!  I have been keeping blog (journal) with a lot of information.  The sites are slowly being added as they get approved but supposed to be throughout the US and parts of Europe.  The web site to check is clinicaltrials.gov and the identifier of the trial is NCT01435044.  The new study is called Quantum and it is just starting up with 3 sites listed and many more to be added.
Avatar universal
thanks for posting this.  i see that two of the arms contain only one drug.  anyone want to venture a guess as to what the chances of SVR with only this one drug?
Avatar universal
Hi,
I am in the trial using psi 938. we were all told temp. to stop using the drugs due to liver toxicity in some patients. I had been taking it for 5 weeks. I have cirrhosis as well as Hep. C genotype2. Currently the results of my viral load is pending, but 2 weeks ago my viral load dropped from approx.1.5 million to 68. My liver enzymes dropped from 235 and 195 to 54 and 40 I feel pretty good, though I didn't feel so great on the drug.
We will be monitored and if needed will resume treatment on an individual basis. I cannot speak for the others but I heard that those taking the new drugs all experienced a significant drop in their viral loads.
I am hopeful-this may be what we have been waiting for.
Avatar universal
Thanks very much for posting this information. I have just asked my specialist to put me on the candidate list for one of these trials. He is very excited about the new drugs being developed. I am not treatment naive so not so easy to qualify for a trial but there are some possibilities from time to time.

Sorry to hear that you had to stop treatment. Hoping you get the best possible outcome. It would be stunning if you cleared although 5 weeks treatment is very short.

Good luck.
Avatar universal
Thank you for your good wishes. I was just told that if I am not cleared (they will monitor me for 3 weeks) I will be put on 7977 and ribivirin. Apparently the combo is showing to be extremely effective.
I am pretty new to this, have stayed in my brain fog during most of my time with cirrhosis, so anything I say is related to my own experience, I really don't know much about the studies or drugs.
Avatar universal
I am about to go on the newest trial, interferon ribavarin plus four antivirals (one could be a placebo).  I am geno 1A and hv tried two times before with no success.

Re your question....the only side-effects are the interferon and ribavarin. The anti virals do not worsen those effects.  Congrats on clearing HIV after 2weeks....this means you might not have to be on therapy for full six months!
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