73% SVR for Prior Relapsers and 41% SVR for Prior Non-Responders per New Interim Telaprevir Data

[jmjm530]

This was posted previously but thought a different heading might cause more attention to the very encouraging Telaprevir results just released for both prior relapsers, prior non-responders.

Of note is that prior relapsers show a 73% SVR rate on 12 weeks of Telaprevir plus combo plus 12 weeks combo (24 weeks total treatment). And that 41% of previous non-responders also achieved SVR, a group that some were concerned would not be able to reach SVR because of previous non-response. These are intent-to-treat numbers so per protocol numbers would be higher.  Drop out rates were 7% in the Telaprevir group and 4% in the control group without Telaprevir. This seems less than in previous Telaprevir trials and I'm guessing it's because of the shorter exposure (12 weeks) to Telaprevir. Apparently more than 12 weeks of Telaprevir gives no additional benefit.

Interim Analysis Results

PROVE 3 is a randomized, double-blind, placebo-controlled Phase 2b study that enrolled patients who failed prior treatment with peg-IFN and RBV. Patients enrolled in PROVE 3 included prior non-responders (including null responders), prior relapsers and prior breakthroughs to peg-IFN and RBV treatment. The interim analysis included 453 patients that were enrolled and received at least one dose of study drug. In the interim analysis, 52% (60 of 115) of patients randomized to receive a 24-week telaprevir-based regimen (12 weeks of telaprevir in combination with peg-IFN and RBV, followed by 12 weeks of peg-IFN and RBV alone) achieved undetectable HCV RNA (<10 IU/mL; Roche TaqMan) 12 weeks post-treatment (SVR12). Of the 115 patients, 66 were categorized as non-responders to prior treatment (defined as patients who never achieved undetectable HCV RNA during prior treatment, including null responders), 40 were prior relapsers (defined as patients who had undetectable HCV RNA at the completion of prior treatment, but relapsed during follow-up), and 9 were prior breakthroughs (defined as patients who had viral rebound during prior treatment). Among patients receiving the 24-week telaprevir-based regimen, 41% (27 of 66) of the prior non-responders, 73% (29 of 40) of prior relapsers, and 44% (4 of 9) of prior breakthroughs achieved SVR 12.

“Patients who have not achieved a sustained virologic response with one or more courses of prior interferon-based therapy represent a significant unmet medical need. These patients have few or no available treatment options and they are at increased risk for progressive liver disease,” said John McHutchison, M.D., Principal Investigator for the PROVE 3 Study and Associate Director of Duke Clinical Research Institute.

A summary of available on-treatment and post-treatment antiviral data from the 24-week telaprevir-based regimen is presented below:
Undetectable HCV-RNA by Response to Prior Peg-IFN/RBV Treatment (PROVE 3 24-week regimen; 12 weeks telaprevir+peg-IFN+RBV, followed by 12 weeks peg-IFN+RBV);intent-to-treat analysis
                          Week 12    Week 24 (end of treatment)    SVR 12 (week 36; 12 weeks post-treatment)
Non-responders (n=66)   71%           65%                                     41%
Relapsers (n=40)      88%            83%                                         73%
Breakthroughs (n=9)   44%              44%                                        44%
Total (n=115)          75%          70%                                    52%

http://news.moneycentral.msn.com/ticker/article.aspx?Feed=BW&Date=20080609&ID=8746457&Symbol=VRTX

[foofighter]

Whew! And I know when the results come, it will be the best news ever.

Foo

[Isobella]

Yay!!

I thought so, but obviously we are all waiting right along with you for these results---you gotta be feeling the love :-)

Izzy

[Andiamo1]

I am sorry to post such a confusing message.  I have not relapsed; I was trying to say that I was in the group that had the best chance of SVR and I also treated longer than anyone in the just release data.  All good news!
Sorry for the confusion,

Eric

[Cheesegrater]

Have been in the roll over study prove 3.
On my way to the week 12 point.
Over 6 log at baseline.
I never developed rash.
Was nauseous only on the first day after treatment started, then half the next day.
Non detected at week 4.
Slight blip at week 8 (<60 Iu/mL)

Have been working out daily since last 2 weeks to try to improve my chances. Something I couldn't do when off treatment because it made me feel horrid.

Happy to get the chance to try this stuff! Happy to hear it is  making a difference to so many people!

Cheese.

[Isobella]

I caught that as well-but I am hoping that he meant he was a relapser BEFORE this trial.  Surely he didn't get the results already-he just had the blood work today.....

[foofighter]

Did I miss something? Did Eric already get his results? Where did you see he relapsed? It just can't be! It isn't on his profile.

Foo