Pegintron(TM) Plus Weight-Based Rebetol(R) Resulted in Higher SVR Than Flat Dosing; Low Relapse Rates in Patients With Chronic H...(f of thedivision of gastroenterology and...),Health

"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 Robert S. Brown Jr., M.D., M.P.H., co-principal investigator of the WIN-R study, and chief of the division of abdominal organ transplantation, New York-Presbyterian Hospital/Columbia University Medical Center.

In WIN-R (Weight-Based Dosing of PEGINTRON and REBETOL), SVR rates remained consistent with increased body weight for patients receiving weight- based REBETOL, 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, 24 weeks of weight-based dosed combination therapy was as effective as 48 weeks. For patients with genotype 1, 48 weeks of PEGINTRON and REBETOL combination therapy is recommended.

In the WIN-R study, there was a higher rate of anemia 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.

"We are very pleased with the FDA approval of these label revisions. Schering-Plough has long championed an individualized approach to hepatitis C treatment with weight-based PEGINTRON and REBETOL combination therapy to help optimize outcomes for patients," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "Further underscoring this individualized approach, we recently reported results of another larger study in more than 3,000 U.S. patients, known as the IDEAL stud
'/>"/>