VideoDDW/Final Results of A Rollover Study Assessing Telaprevir in Combination with Peginterferon Alfa-2A and Ribavirin in Chronic Hepatitis C

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VideoDDW/Final Results of A Rollover Study Assessing Telaprevir in Combination with Peginterferon Alfa-2A and Ribavirin in Chronic Hepatitis C

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New Drug Treatments DDW® 2010

Pharmaceuticals: Hepatitis C, Crohn's Disease and Ulcerative Colitis

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NEW ORLEANS, LA (May 4, 2010) – Research being presented at Digestive Disease Week® (DDW®) shows that using telaprevir in the treatment regimen for hepatitis C virus (HCV) is highly effective, particularly in difficult-to-treat cases. Further studies show that aspirin may be a factor in the development of inflammatory bowel disease. DDW is the largest international gathering of physicians and researchers in the field of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

.."Treatment for hepatitis C has historically been challenging, with available treatment options being uncomfortable for the patient and sometimes ineffective, but the science presented here offers hope for the patients living with the infection and the doctors who treat them," said Philip S. Schoenfeld, MD, MSEd, MSc (Epi), associate professor of medicine University of Michigan School of Medicine. "Inflammatory bowel disease, including (view Info Here): Crohn’s disease, has been historically difficult to treat, partly because we’re still learning how the disease occurs. These data will help us better understand this debilitating disease."

..Final Results of A Rollover Study Assessing Telaprevir in Combination with Peginterferon Alfa-2A and Ribavirin in Chronic Hepatitis C Patients with Well-Characterized Null Response, Partial Response, Virtual Breakthrough, or Relapse After Prior PR Treatment (Abstract #311)Researchers at Duke Clinical Research Institute found that patients who had not improved with standard HCV treatment significantly improved response rates when telaprevir was added to the standard treatment regimen.

...A previous study had suggested that patients who had failed prior treatments benefited from telaprevir, but the Duke researchers did not have records from these patients to know the full details of their previous treatment. In this study, researchers studied patients from previous telaprevir trials during which patients received standard treatment with peginterferon and ribavirin, but placebo instead of telaprevir, a drug frequently used in the treatment of HCV.Researchers looked at 117 patients, all of whom received treatment with the combination of pegylated interferon alfa, ribavirin and telaprevir. All patients received 12 weeks of the triple combination and then 12 to 36 more weeks of pegylated interferon alfa and ribavirin.Telaprevir was discontinued after 12 weeks, and the patients continued for 12 or 36 more weeks of peginterferon alfa and ribavirin. Results showed that null

responders — patients who did not respond to previous treatment (<1-log10> .The other groups received the 12 weeks of triple combination therapy plus 12 more weeks of peginterferon alfa and ribavirin. For patients who were partial responders to previous therapy, 60 percent were cured with the triple combination. For patients who relapsed with previous therapy, 92 percent were cured with the triple combination.

.."The results seen in this trial were encouraging for all patient groups studied," said J. Muir, MD, director of GI/hepatology research at Duke Clinical Research Institute, Duke University. "This study is yet another indication that telaprevir is consistently showing potential efficacy as a new treatment option for patients who have failed treatment, but also reinforces the additional side effects that come with adding this drug to standard treatments.".

The study was funded by Vertex Pharmaceuticals, which is developing telaprevir.Dr. Muir will present these data on Monday, May 3 at 9 a.m. CT in 383-385, Ernest N. Morial Convention Center.

Dr. Muir will present these data on Monday, May 3 at 9 a.m. CT in 383-385, Ernest N. Morial Convention Center.Improved Sustained Virologic Response (SVR) in “Difficult to Cure†Patients Treated with Telaprevir (T) in Combination with Peginterferon Alfa-2a (P) and Ribavirin ®: An Analysis from the PROVE3 Study (Abstract #T2002)A new study from Duke Clinical Research Institute shows that telaprevir is effective in difficult-to-treat populations with HCV. Researchers focused on populations traditionally referred to as difficult to treat, including patients with a high viral load (very severe infection), cirrhosis, older or obese patients, or African Americans, and found they all experienced improved response rates. The findings are significant because previous studies have not achieved such high response rates.This research was a

secondary analysis of a large prospective, randomized, controlled trial, PROVE3, which enrolled patients who did not respond to previous standard treatment with peginterferon alfa and ribavirin. Patients (453) were assigned to one of four treatment approaches, which included varying combinations of telaprevir in combination with peginterferon alfa and ribavirin, as well as peginterferon alfa, ribavirin and placebo."These findings, if confirmed in larger phase III studies, could provide a meaningful treatment option for clinicians to consider when dealing with patients who have failed an initial standard of care treatment regimen," said J. Muir, MD, director of GI/hepatology research at Duke Clinical Research Institute, Duke University.Dr. Muir cautioned that this study is a secondary analysis, and the numbers in each subgroup are small; they need to be further confirmed in larger trials. The study was funded by

Vertex Pharmaceuticals, which is developing telaprevir.Dr. Muir will present these data on Tuesday, May 4 at from 8:00 a.m. CT in Hall F, Ernest N. Morial Convention Center.

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