Second dose labs PSI 7977 and BMS790052 Study..amazing

[gonnabhepcfree]

July 13...starting numbers 2,355.050 unit/ml  (6.4 log)
1st dose 8/3 -8/4 labs          4838 (3.7 log)
2nd dose 8/4-8/5 labs            488 (2.7)
pretty amazing results and I am excited for myself and everyone afflicted with Hep C..I believe they are finally onto something----and the best part for me besides the low viral load after 8 pills..NO SIDE EFFECTS..

[viaduk]

I'm not sure which PI you treated with, but Pharmasset just announced two new arms that may be of interest to you.  I cut and pasted the relevant info below.

Good luck.




Four new treatment arms are now being added to the study; two in genotype 1 treatment-naïve subjects and two in subjects who have failed therapy with pegylated interferon and ribavirin in combination with telaprevir or boceprevir. One hundred and twenty patients will be enrolled in the following four arms (2:2:1:1):

* PSI-7977 400mg QD and daclatasvir 60mg QD for 12 weeks in HCV genotype 1 treatment-naïve patients;
* PSI-7977 400mg QD, daclatasvir 60mg QD and ribavirin for 12 weeks in HCV genotype 1 treatment-naive patients;
* PSI-7977 400mg QD and daclatasvir 60mg QD for 12 weeks in genotype 1 HCV patients who have previously failed telaprevir or boceprevir treatment;
* PSI-7977 400mg QD, daclatasvir 60mg QD and ribavirin for 12 weeks in HCV genotype 1 patients who have previously failed telaprevir or boceprevir treatment.


Additional details can be found at www.clinicaltrials.gov.

[willbb]

We all should certainly have faith  that  our doctors know what they are talking about :)
Best..
Will

[gonnabhepcfree]

My use of right around the corner was two to five years I have had this disease for probably close to forty years.  But thanki you for clarifying for others. Most Dr's I don't know about but my Dr I believe he knows what he's talking about.  Have a nice day..

[willbb]

Good luck to you for the future treaments for all strains I beleive is right around the corner with an all oral regime.  My Dr said recently its just finding the best ones now.  
-----------------------------------------------------------------------------------------------------
No one waiting to treat should necessarily infer that this means in a matter of months or even a year or two... at where they are in trials to date newer meds could still very likely take 3 to 5 years...some doctors are opining possibly as soon as 2   .

Most doctors ..only have opinions... none of them know definitevly  and it seems all their opinions differ.

Five years ago there were  many doctors opining that Telaprivir and Victrelis would be on the market within 2 to three years..obvooiusly they were  2 to three years of...

Point being ..anyone  who is considering treating ..there has never been a better time ..with the chances of success at approx. 80 %..especially anyone with moderate or worse liver damage
Will

[curiouslady1]

Sorry for the word wall.  It makes it hard to read.  

[curiouslady1]

Apparently it is 40 patients for PSI 7977 achieving SVR.  I am genotype 1a and I, along with several other genotype 1s achieved essentially the same results as the poster above.   I had a rapid response from 13 mill to 50 in 7 days and then UND within a few more days and I have held it since.  Certainly it is too early to determine if any of us will be SVR.  However, it does look good for 1a also.  This company is interested in pan-genotypic cure.  I have no idea what your study was like so I cannot speak to it.  I know that this was the best bet I had because I was not willing to take drugs which had severe side effects, not willing to take drugs which were ineffective with my genotype and not willing to take a cocktail of more than two because I felt that was an indication that the drugs were too weak.  I would not have taken BMS 7900052 alone or with SOC.  I enrolled in the study because of PSI 7977 and its high barrier to resistance.  There was already preliminary results which were fairly dramatic across genotypes when I started.  I looked at the preliminary data that was available and studied the experimental design of the trial closely.  I examined the site and the doctors involved.  I also knew and know that if I fail I can,if I so choose, to undergo the current treatments because I am taking a different type of drug.  There were a lot of win-wins with my trial.  However, it is still a crap shoot.  You and I both know that, as experimental research subjects we cannot call the shots and we willingly sacrifice certainties when we enter the trials.  We can study the situation closely but we can still fail.  If there was no chance of failure, it wouldn't be a trial.  Without people willing to walk into the fire, there would be no human research.  In fact, if others on our trials have safety issues, we could be removed immediately from our treatment even if it IS working.  It is a crap shoot.  You play the odds.  In this trial, I believe the odds are good that I will get SVR.  The odds I feel are better that I will get SVR than they are that I would not get some additional malady if I had waited for another drug to come to market.  As well, for some of us, a crap shoot is much better than walking into a treatment protocol which has such severe side effects as the one on the market.  As I am over 60 it was simply no contest and I am willing to face the consequences of my decision.  

I am very sorry for your bad luck and for your hurt but I think you will be able to treat again because trials will continue and new drugs will be there for you; perhaps sooner rather than later.  

[gonnabhepcfree]

My waiting was over due to my biospy.  I am just grateful that there was an interferon trial for me.  My Dr was having great results with another PSi 7977 trial ATOMIC and felt I should enroll..I worked as a phlebotomist for many years at the VA and saw the before, during and after treatement patients and it scared me right out of treating with interferon.  Good luck to you for the future treaments for all strains I beleive is right around the corner with an all oral regime.  My Dr said recently its just finding the best ones now.  

[Cheesegrater]

Yes, veru interesting news.
No doubt you were genotype 2 or 3.

Genotype 1A has been shown to develop more resistant mutations to BMS-790052 than 1b.
Whether 7977/790052 will prove to be sufficient by themselves, or if riba (or peg/riba) will be needed for genotype 1 patients is still to be seen.
Recent results for geno2/3 saying 100% cure rate were with only 10 patients. That's a far cry from a statistically significant population.

I think the pharmas should be careful. Trying to be first with a cure, taking short cuts (new 7977/790052 study planned...only 12 weeks of treatment for genotype 1! Geez!) and putting people at risk for resistant strains (and elimination from future trials because of mutations/ non-naive).

I've been through the protease trial and failed. To date (3+ years) I have had no trials come up that would take me because I am a null responder and have failed a protease. If I fail a polymerase because of too short duration trial treatment or breakthrough that's it. I won't see treatment for at least another 3-4 years.

Be careful what trial you jump into. Sometimes better to wait for a sure thing.

Cheese

[attagrl]

Thanks! Just got home from my D-1 screening and so far so good. As long as nothing crazy comes up from my blood work (like failing the drug test again lol), I find out my study arm this afternoon! AGHGHGHGH... I'm a nervous wreck. :P

[gonnabhepcfree]

On Saturday my coordinator said they are still screening till they get notification not to.. Good luck tomorrow..be well ...stay positive..

[gonnabhepcfree]

Yes it is an all oral study unless the study medication doesn't work and then they will add the SOC..interferon etc.. if you go to www.clinicaltrials.gov.. type in the search fields  NCTO1359644..It will list everywhere they are recruiting...

[attagrl]

Holy cr*p, man! That's AMAZING NEWS! I'm so happy for you and be sure to keep us up to date as you hear more.

As for the study, my mom was talking to the study coordinator for our site and she said that they aren't accepting any additional patients for screenings on a national basis, that they've reached their number. :/ For anyone who is considering applying, *definitely* still do -- that's information given to me second hand, and there could still be people who drop out. But there is definitely a timeliness factor so I wouldn't sit on it for much longer.

[curiouslady1]

Here is web site for info about the study.  

http://clinicaltrials.gov/  In the key word line simply put in hepatitis c AND (the name of your state) Then most or all of the studies currently running, recruiting or recently completed will be listed.  

There are restrictions in this study so you want to study it to see if the study is running in your state and whether you qualify.  Relevant details are that it is for people who have never been treated for hep c with interferon related products and who don't have certain untreated diseases and who are GT 1, 2, 3

[mykids247]

Sorry forgot to ask. Is this all oral or are injections still involved? Sorry again if its a dumb question still on the learning curve.

[mykids247]

this is AMAZING, I am geno type 2 and most of the trials have been for 1. I will be on the phone Monday morning talking to my Dr, about this. So if I understand this, this is a trial that you are in. Still new to this and have not started treating YET>My Dr. was involved with the two new drugs that were just released so he should be up to speed on this. Would you think?

[gonnabhepcfree]

Yes I started both drugs at the same time PSI 7977 and BMS 790052..these drugs are very promising..indeed..are you thinking of inquiring about the study? ..good luck if so ..I would do it soon though.......

[curiouslady1]

http://www.hivandhepatitis.com/hep_c/news/2011/0603_2011_a.html

[curiouslady1]

Yes, these seem to be a miracle drug combo for GT 2 and 3.

[Willy50]

Is this the study?
http://clinicaltrials.gov/ct2/show/NCT01359644?term=PSI+7977+and+BMS790052&rank=1

You'll note that some arms predose  7 days w/ PSI 7977 before the BMS is added.

Did you start both the same time? (just making sure; looks like you started both the same time)

Also, what genotype are you?

best,
Willy

[James10500]

8 pills ! Wow........good luck, exciting indeed!