Thu, Sep 18, 2014, 11:35 PM EDT - U.S. Markets closed

Recent

% | $
Quotes you view appear here for quick access.

Vertex Pharmaceuticals Incorporated Message Board

  • llabtechtwo llabtechtwo Nov 13, 2012 12:18 AM Flag

    SVR 4 IS NOT! SVR 12!! IS NOT! SVR 24!!

    As the ELECTRON study points out... treating hep c without interferon is extremely challenging!! Now I have to wait another six months to see if GILD's new data holds any weight because if you go on previous results their SVR 12 is going to fall like a rock! Really its just a guess which is funny because SVR 24 is the only number that matters and we are a long long way from getting that answer!!

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • True... EOT does not translate to SVR4... and SVR4 is still too early but starts to be a good indicator. SVR12, however... that you may want to hang your hat on these days. Here is a bit of info on drug pharmacokinetics. Peg has a pretty long half-life (not to mention ribavirin...why do you think the ribavirin label tells you to practice safe you-know-what for a long time AFTER you finish taking the drug?)... anyway you need to get to SVR12 with Peg/Riba just to see if there will be a lot of relapse due to this half-life (I didn't make this up... there is good data in the public domain from companies and the FDA to show this). If you are giving oral therapies with a short half-life, the drug pressure is gone rapidly. HCV also grows very fast (just ask a liver transplant patient) once the drug pressure is removed. I would have strong doubts you will see much relapse if any after SVR12. Probably you will see some patients in the study lost to follow-up between 12 and 24 (that is a long time to expect someone to come back for a blood draw) that may be counted conservatively as a "failure"... but that is really just a failure to obtain a blood draw!

      I always find it so funny when people try to say things on these boards to get folks all crazy. I don't even have holding in these companies... I just know the science and it annoys me when people start shouting that the earth is flat and herbs and berries will cure you of all your woes.

    • Abstract

      A sustained virologic response (SVR) in patients with chronic hepatitis C receiving pegylated interferon (PEG-IFN) plus ribavirin is defined as undetectable serum HCV-RNA at 24 weeks (W+24) posttreatment follow-up. Viral load outcome in patients with virological relapse (VR) has not been explored. This study evaluated whether the assessment of serum HCV-RNA 12 weeks (W+12) after the end of treatment was as relevant as W+24 to evaluate SVR in 573 patients who received combination PEG-IFN and ribavirin and had a virological response at the end of treatment. Serum HCV-RNA was measured, using a new assay based on transcription-mediated amplification (TMA) with a lowest detection limit of 5-10 IU/mL, at W+12 and W+24 after the end of treatment. VR was defined as reappearance of detectable HCV-RNA at W+24 posttreatment follow-up. The positive predictive value (PPV) of undetectable serum HCV-RNA at W+12 was evaluated to identify patients with SVR, and the viral load outcome was measured in relapse patients. At the W+24 posttreatment follow-up, 408 (71%) patients had an SVR, 181 (71.2%) were treated with PEG-IFNalpha-2a and ribavirin, and 227 (71.1%) were treated with PEG-IFNalpha-2b and ribavirin. At W+12, serum HCV-RNA was undetectable in 409 patients, and 408 patients were SVR (PPV 99.7%, 95% confidence interval 99.1-100). In relapse patients, serum HCV-RNA levels were 5.623 +/- 0.748, 4.979 +/- 0.870, and 5.216 +/- 0.758 log(10) IU/mL at baseline, W+12, and W+24, respectively.
      Conclusion: Our results show that the assessment of serum HCV-RNA 12 weeks after the end of treatment, using the highly sensitive TMA assay (PPV 99.7%), is as relevant as after 24 weeks to predict SVR and make decisions on the management of treated patients, suggesting a new definition for SVR.

 
VRTX
97.35+2.85(+3.02%)Sep 18 4:00 PMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.
Oracle Corporation
NYSEThu, Sep 18, 2014 4:04 PM EDT
Concur Technologies, Inc.
NasdaqGSThu, Sep 18, 2014 4:00 PM EDT
Rite Aid Corporation
NYSEThu, Sep 18, 2014 4:02 PM EDT