Pharmasset 28-day Phase 2a Study with PSI-7977

http://www.hcvadvocate.org/news/newsRev/2010/NewsRev-360.html#_Pharmasset_Announces_Results

"94% or 93% of patients achieved undetectable HCV RNA levels following 28 days of treatment with PSI-7977 200mg or 400mg QD, respectively, in combination with Pegasys® and Copegus®

Safety and tolerability across all doses were comparable to placebo administered with Pegasys® and Copegus®"

"We are encouraged by the emerging clinical profile of PSI-7977, which was well-tolerated by the patients in this study, and which confirms the consistently high RVR rates of these nucleoside and nucleotide analogs," stated M. Michelle Berrey, M.D., MPH, Chief Medical Officer of Pharmasset. "Our platform technology continues to generate nucleoside/tide analogs with a high degree of efficacy, high barrier to resistance, and a safety profile that we believe differentiates them from other classes of direct acting antivirals (DAA). We plan to quickly progress PSI-7977 into phase 2b studies starting in the fourth quarter 2010, to generate longer term efficacy and safety
data."

"Patients were stratified by IL28B status to ensure balance across cohorts and no patient was excluded based on their status."

[willing]

thanks for posting - another promising new kid on the block - it's going to be hard to keep up with them all.  

Interesting about  "phase 2b studies starting in the fourth quarter 2010"; so the ongoing phase IIb for r7128 and for psi7977 will be overlapping. Does this mean Pharmasset will be competing with Roche after licensing r7128 to it ? Sure hope the influx of promising new candidates doesn't delay/derail  any of those further down the pipeline...

Also interesting that patients' IL28B readings are  accepted as a proxy for how ifn-responsive they are..

[dointime]

Yes, Pharmasset look like the smartest guys on the block to me.

They've now produced 2 very credible candidates with high efficacy, no safety worries so far, high barrier to resistance, and they are factoring in ifn-responsiveness early in their trials.  

We already have one non-responder on this forum who got SVR in a r7128 trial.  I wish we could get news from more people in the trials of these 2 drugs to see if Pharmasset really have cracked it for non-responders.  If they have then a lot of people, including me, would be almost home free.

dointime

[spectda]

incredible numbers, hopefully it will work for people who were resistant to current soc and soc plus telaprevir or boceprevir. Of course this was a short trial, but they are looking really good

[nygirl7]

I wonder what the SVR rates are going to be - it's amazing years ago when I started all there was was SOC or Infergen.  What progress they have really been making. It's so why I'm not anti big pharma without them and their work look where we'd all be. Great news for sure just the fact that they are all trying so hard. Boy to only know which one will be the big $$$ maker I'd invest myself!

[spectda]

What's really tough is when you have a disease that is life threatening but so rare that the drug companies have no incentive to find a cure.

[susan400]

I wouldn't mind being accepted into a non-responder trial for this one!  Wonder if they'd take a Telaprevir failure patient?

I'm getting sick and tired of waiting for a TX to be available to me that will do the trick and get me cleared of this dumb thing.  Enough is enough already.  I'm sick of the wait.  I don't want to hear anymore of this cr*p about having to wait another 5 yrs for such and such and on and on and on.  I have been messing around with treatments since 1997!!!!   How long am I going to have to be wasting my life on this darn disease and treatments????

There, now, I've whined and I can stop that and move on to something else to talk about.  

Susan400

[dointime]

The good news is that having telaprevir resistance should make no difference to these drugs.  That is why I am so interested in them.

You could find that you are in particular demand for a trial at some point because of your non-responder / tel.resistant status.  My own doc can't get enough of my blood to study because I'm the only person he's got with tel. resistance.    

I feel the same about the waiting.  I would just like to know what it feels like to be alive with no virus in me dragging me down.  By the way, that was a great whine, made me smile.  You said it all.  

dointime  

[spectda]

I thought these drugs target specific parts of the virus so they could not mutate. If they have already mutated because of TX, doesn't that mean the drugs wouldn't be able to kill the mutations they were not designed for? I am not clear about how the mutations work. From what I have read it seems that they eventually die off, but I am not sure. If they die off then I would expect these drugs could work.

[dointime]

" I am not clear about how the mutations work. "

Drug resistance is a big subject.  You'll need to do a bit of digging around google, see if you can find some recent papers on it.  Keep asking questions and you'll get there.  Sorry not to be more specific.

dointime