For Those Who Have Done the PI's

[JennyPenny2009]

I know those of you who have been in the boceprevir or telaprevir trials have also done SOC along with the PI's. Do any of you know whether or not the protease inhibitors add to the interferon's suppression of the white blood cells? I know anemia is a problem especially with boceprevir but what about ANC? I'm asking because I can't ever take interferon again and I am looking forward to the trials with two PI's and no SOC.

[newleaf09]

My informed consent from the boceprevir trial made clear that it would decrease both hemoglobinn and neutrophils.

[JennyPenny2009]

You are a wealth of  information. We are not attending EASL but will definitely go to AASLD. I'm on one of Vertex's advisory boards (for clinicians, as a patient) so I may get some answers there as well. I am desperate for something that won't drop my ANC to zero. Again, thank you so much for your help.

[Willy50]

Here is a somewhat recent from the inform trials;
http://www.hivandhepatitis.com/2009icr/aasld/docs/111309_a.html

You can plug this into clinicaltrials and get further details on the design.

I believe I read that they were going to do a middle length more interim trial, but that this was canceled, opting instead for a longer period more complete trial.  I think one might infer that the INFORM 1 trial was successful enough that they decided to go for the gold.

It appears that Vertex is pursuing that approach.  They are immediately launching an intent to treat and cure trial.  They may be able to do that based on all the clinical data they have with TVR and the tox results of treating non-infected individuals with TVR and VX-222 earlier in the year.  They may already have some of the data you desire but it is a question mark as to whether it could be released.  

My assumption is that they intend to release preliminary data on the Stat-C trial (as they've claimed in presentations) in the second half of 2010 (AASLD?).  When they end up picking a subsequent dosing for FDA approval, however, the flow of information may dry up a bit as blinding could come more into play.

IF you want more data on the new Vertex trial, go to clinical trials.gov and type in *VX-222, Telaprevir*    (Never mind; here it is...)

http://clinicaltrials.gov/ct2/show/NCT01080222?term=VX-222%2C+telaprevir&rank=1

You'll see the new trial.  It started with only 100 openings, but I believe they may have opened up 2 more arms of 25 people per arm.

Will you be attending either EASL or AASLD?

best,
Willy

[JennyPenny2009]

Thank you so much for the info. Appreciate your help.

[Willy50]

Jenny, I think that there was a bit more anemia in TVR trials (than in SOC).  The anemia was worse in the Boceprevir trials than in TVR trials.

I think that the real question is how the anemia will be in the trials which feature only the dual acting antivirals (a protease and polymerase inhibitor combined), either as a sole components or when combined with IFN.

The Inform1 trial may have an answer to that.  I would guess there will be a more complete presentation at this next EASL.  There may be data on adverse events, but I'm not sure that I've seen it broken down to specifics.  That data may be available from the company, however.

The Stat-C trial that Verttex is now starting w/ Telaprevir and VX-222 is projected to have some sort of release of information in the 2nd half of this year.  Just how much and what type of information, has not been discussed.  It cannot reveal SVR rates but there may be early response rates and discontinuation data.  This trial is constructed so that the arms are either with or without SOC.  There are no arms with the DDA's acting with either riba alone or IFN alone.  (If I recall the Inform 1 trial did, however..... but I don't positively recall)

Either way you may have some actual data to go on relatively soon.

best,
Willy