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Title: Combining Peginterferon With Weight-Based Ribavirin Increases Virologic Response in Hepatitis C

"Combining Peginterferon With Weight-Based Ribavirin Increases Virologic Response in Hepatitis C"

NEW YORK -- March 27, 2008 -- The US Food and Drug Administration (FDA) has approved label revisions for peginterferon alfa-2b (Pegintron) and ribavirin (Rebetol) combination therapy for chronic hepatitis C, recommending dosing of ribavirin (800-1400 mg daily) based on patient body weight. The revised label also recommends a shorter, 24-week course of the combination therapy for patients with chronic hepatitis C virus (HCV) genotype 2 or 3. The revisions represent the first FDA approval of a 1400-mg ribavirin dose and the widest ribavirin dosing range approved for use in combination with peginterferon for treating chronic hepatitis C in patients with compensated liver disease. The label changes are based on the results of the WIN-R trial,(1) the largest US hepatitis C study, conducted in more than 4,900 patients. The study showed that peginterferon (1.5 mcg/kg once weekly) and ribavirin (800-1400 mg daily based on patient body weight) resulted in a significantly higher sustained virologic response (SVR) compared with peginterferon in combination with a flat 800-mg daily dose of ribavirin ([P = .01), the previously labelled dose. Importantly, the study reported low relapse rates consistent with other Peginterferon studies.(2,3)

"[Peginterferon] and weight-based ribavirin was significantly more effective than flat-dosed ribavirin, especially in genotype 1 patients, and provided consistent efficacy across all weight groups," said WIN-R principal investigator Ira M. Jacobson, MD, Vincent Astor Professor of Clinical Medicine, Weill Medical College of Cornell University, and Chief, Division of Gastroenterology and Hepatology, New York Presbyterian Hospital/Weill Cornell Medical Center, New York.

"It is reassuring to now have a validated, FDA-approved regimen that will allow us to use a novel 1400 mg ribavirin dose in our highest-weight hepatitis C patients, who previously were among the most difficult to treat successfully," said co-principal study investigator Robert S. Brown Jr, MD, MPH., Chief, Division of Abdominal Organ Transplantation, New York-Presbyterian Hospital/Columbia University Medical Center, New York.

In WIN-R (Weight-Based Dosing of Pegintron and Rebetol), SVR rates remained consistent with increased body weight for patients receiving weight- based ribavirin, but SVR decreased as body weight increased for patients receiving a flat dose. The study also showed that for patients with HCV genotype 2 or 3, a weight-based dosed combination therapy for 24 weeks was as effective as 48 weeks. For patients with genotype 1, 48 weeks of peginterferon and ribavirin combination therapy is recommended.

In the WIN-R study, there was a higher rate of anaemia among patients in the weight-based dosing group compared to the flat-dosing group. The majority of these cases were mild and responded to dose reductions. There was no difference seen in the rate of serious adverse events between the two groups, and there were similar rates of discontinuations for adverse events.

WIN-R was an investigator-initiated clinical study supported by Schering- Plough Corporation as part of a post-marketing commitment to the FDA.

References:

1. Jacobson IM et al. Peginterferon alfa-2b and Weight-Based or Flat-Dose Ribavirin in Chronic Hepatitis C Patients: A Randomized Trial. Hepatology. 2007; 46:971-981.
2. Manns MP et al. Peginterferon alfa-2b plus Ribavirin Compared with Interferon alfa-2b plus Ribavirin for Initial Treatment of Chronic Hepatitis C: A Randomized Trial. Lancet. 2001;358:958-965.
3. The IDEAL (Individualized Dosing Efficacy vs Flat Dosing to Assess Optimal Pegylated Interferon Therapy) study. Schering-Plough press release, Jan. 14, 2008.

SOURCE: Schering-Plough Corporation

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