good news, not such good news

[willows]

Well, most all of the news has filtered out of the EASL conference in Madrid and it's very good news for Vertex, the manufacturer of Telaprevir and especially good news for any of us non-responders.  The SVR rate is up from about 10% success rate on retreating to about 60% and I, for one, am pretty darn happy.  

There is talk about Vertex asking for approval for non-responders earlier than 2011, perhaps next year with the support of Johnson and Johnson, one it's partners in the development of Telaprevir.  The rash is still a big big issue but not enough to stop the trials and hopefully not enough to keep Telaprevir from being approved.  If and when I get lucky enough to take Telaprevir, I'm sure the rash will be a big freakin deal, that's where all the good posters here will be a big help to me.

Schering-Plough has been making noise about their PI, boceprevir, but so far, the data from their trials is not really comparable to Telaprevir and they are far behind Vertex in the required FDA trials.  So I'm crossing my fingers for some MORE good news next year.  Personally, I was ready to try SOC with a 10% of cure, so you can imagine how ready I am to try triple therapy for 24 weeks with a 60% chance to finally be rid of my virus.  

Cross your fingers.

Willow

[HectorSF]

Hi Mike!

"Anybody have an idea when Telaprevir might be approved for first-timers?"

Vertex says if all goes well with trials they will be applying to the FDA for new drug approval in 2011.


Hector

[HectorSF]

For those interested in the PROVE 1 Study with Telaprevir there is a summary at the following link (Use must sign up to view the document).

http://clinicaloptions.com/Hepatitis/Conference Coverage/Milan 2008/Tracks/Investigational HCV/Capsules/4.aspx


Here is some of the text but I lost a lot of the formatting and all the graphic charts...Sorry

CCO Independent Conference Coverage of the 2008 Annual Meeting of the European Association for the Study of the Liver*


PROVE 1 Study: Combination Telaprevir, Peginterferon alfa-2a, and Ribavirin Therapy Has Rapid and Sustained Antiviral Activity in HCV Genotype 1 Patients
Posting Date: April 25, 2008

Randomized, placebo-controlled phase II study (PROVE 1)

Summary of Key Conclusions
* 12 weeks of telaprevir combined with 24 or 48 weeks of peginterferon alfa-2a and ribavirin produces significantly higher sustained virologic response (SVR) rates compared with 48-weeks of peginterferon alfa-2a and ribavirin in patients with genotype 1 HCV infection
* Patients achieving a rapid virologic response (RVR) may not achieve additional SVR rate increases after 24 weeks
* Higher rates of diarrhea, rash, pruritus, and anemia associated with telaprevir
* Rash associated with telaprevir more severe
* Rates of other adverse events similar to those seen with peginterferon alfa-2a and ribavirin treatment

Background:
* Telaprevir is an NS3-4A protease inhibitor of HCV in late-stage clinical trials
* Current study investigated safety and efficacy of telaprevir in combination with peginterferon alfa-2a and ribavirin compared with peginterferon alfa-2a and ribavirin alone in genotype 1 HCV patients
* Intent-to-treat analysis of all subjects completing treatment
*24-week posttreatment follow-up

Eligibility:

Inclusion criteria -
* Documented HCV infection
* Genotype 1 HCV
* Treatment naive

Exclusion criteria -
* Cirrhosis

Description of Current Analysis

Primary endpoint - SVR, defined as undetectable HCV RNA (limit of detection 10 IU/mL) 24 weeks after the end of treatment

Statistical analysis
* Intent-to-treat analysis included all randomized subjects receiving ≥ 1 dose of study drug
* Virologic breakthrough: detectable HCV DNA after achieving undetectable or > 1 log10 increase from nadir

Main Findings:
* RVR and SVR higher in the telaprevir-based treatment arms compared with 48 weeks of peginterferon alfa-2a and ribavirin alone

Patients achieving RVR with telaprevir-based treatment
* Comparable SVR rates achieved with 24 weeks or 48 weeks
* Low relapse rates observed in patients receiving telaprevir-based treatment who had undetectable HCV RNA at both Weeks 4 and 12

Among 50 patients with RVR treated > 24 weeks
* 44 completed 48 weeks
* SVR: 44 (100%)
* 6 discontinued treatment between 24 and 48 weeks
* SVR: 2 (33%)
* Relapse: 4 (67%)

Other Outcomes:
* Low rates of virologic breakthrough in telaprevir treated patients (n = 175)
* Majority occurred in first 4 weeks and in patients never achieving undetectable HCV

RNA
Week 1- 4:  5%
Week 1- 12:  7%

* Adverse events reported more frequently in telaprevir-based treatment arms than peginterferon alfa-2a and ribavirin alone
- Gastrointestinal events, skin events (rash, pruritus), and anemia
- Moderate and severe rash more frequent in telaprevir-based treatment arms
- Incidence and severity of other adverse events reported similar vs peginterferon alfa-2a and ribavirin alone

18% discontinued due to adverse events in telaprevir-based treatment arms vs 4% in peginterferon alfa-2a and ribavirin alone arm

Reference:
McHutchison G, Everson GT, Gordon SC, et al. PROVE1: results from a phase 2 study of telaprevir with peginterferon alfa-2a and ribavirin in treatment-naive subjects with hepatitis C. Program and abstracts of the 43rd Annual Meeting of the European Association for the Study of the Liver; April 23-27, 2008; Milan, Italy. Abstract 4.

Hector

[Andiamo1]

Why not try and get into the phase 3 trial|?

[mike716]

Anybody have an idea when Telaprevir might be approved for first-timers? I´m recently diagnosed HCV 1b at age 64, and probably middle-to-late-stage (nothing conclusive yet). I´d sure like to up my chances of clearing on my first time through therapy. Telaprevir could potentially save me from transplant.

Mike

[susan400]

Willow, did you treat with Telaprevir in the early trials?  Or are you waiting to try it still?  For some reason, (maybe I have you mixed up with somebody else), I thought that you were in the trial before.

I was in Prove 3 Group C, the no Riba group and I didn't clear it by week 4.  But, I don't consider myself a non-responder.  I consider myself a partial responder because I had a huge drop in my viral load in week 1-2.  I just rebounded because of not have the Riba in the mix.  

I'd actually like to see them over us Group C people a chance to treat with all 3 drugs.

Susan