Difficult-to-Treat Patient Populations Respond Positively To Hepatitis C Treatment

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials;  Conferences
Article Date: 29 Oct 2009 - 2:00 PDT

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The final results of the PROVE3 study will be presented at this year's annual meeting of the American Association for the Study of Liver Diseases. This phase 2 study was of telaprevir compared to a combination therapy of peginterferon alfa-2a and ribavirin. It intended to measure the 6 month and also 1-year durability of sustained viral response in genotype 1 patients with HCV who failed prior treatment with pegylated interferon and ribavirin.

According to John McHutchison, MD, principal investigator for this study, "This was the first large scale study performed in nonresponders to our current standard of care, which evaluated retreating these patients with the addition of an HCV-specific protease inhibitor. Its importance is, therefore, the proof of principle that adding this potent direct anti-viral allowed us to cure approximately 50 percent of this patient population who have failed therapy and for which no other options currently exists."

The study included 453 patients, and the SVR rates in all treatment groups who received the telaprevir-based therapy were significantly higher than those who received peginterferon alfa-2a and ribavirin. All patients who received telaprevir and achieved virologic response maintained it for 48 weeks after the end of the treatment.

The drug in this nonresponder setting is currently undergoing phase 3 large-scale registration trials to confirm and further elucidate the findings of this current phase 2 study. "To sit across the desk from our hepatitis C patients and tell those that have not responded that with this retreatment strategy they have a 50 percent chance of being cured will be a huge message for patients and providers if confirmed in larger phase 3 clinical trials," concluded Dr. McHutchison.

Abstract title:

PROVE3 final results and 1-year durability of SVR with Telaprevir-based regimen in hepatitis C genotype 1-infected patients with prior nonresponse, viral breakthrough or relapse to Peginterferon-alfa-2a/b and Ribavirin therapy

About AASLD

AASLD is the leading medical society focused solely on advancing the science and practice of hepatology and represents more than 3,300 practitioners, researchers, and allied health professionals worldwide. Founded by physicians in 1950, AASLD has upheld the standards of the profession and fostered research that generates treatment options for the millions of patients with liver diseases.

Source: American Association for the Study of Liver Diseases