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FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C
Date:3/11/2009

erapy and included prior nonresponders (patients who were HCV-RNA positive at the end of a minimum 12 weeks of treatment) and prior relapsers (patients who were HCV-RNA negative at the end of treatment and subsequently relapsed after post-treatment follow-up). In the study, patients who were HCV-RNA negative at week 12 were treated for a total of 48 weeks and followed for 24 weeks post-treatment. Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment.

The overall response rate in the study was 22 percent (497/2,293). Response rates among relapsers overall were 43 percent (130/300) and 35 percent (113/344) for patients previously treated with nonpegylated or pegylated alpha interferon and ribavirin combination therapy, respectively. The response rates in nonresponders overall were 18 percent (158/903) and 6 percent (30/476), respectively.

In the study, 1,470 (64 percent) patients did not achieve undetectable HCV-RNA at treatment week 12, and were offered enrollment into long-term treatment trials, due to an inadequate treatment response. Of the 823 (36 percent) patients who were HCV-RNA undetectable at treatment week 12, those infected with HCV genotype 1 had an SVR rate of 48 percent (245/507), with a range of responses by fibrosis score (F4-F2) of 39-55 percent. Patients infected with HCV genotype 2 or 3 who were HCV-RNA undetectable at treatment week 12 had an overall SVR of 70 percent (196/281), with a range of responses by fibrosis score (F4-F2) of 60-83 percent. For all HCV genotypes, higher fibrosis scores were associated with a decreased likelihood of achieving SVR.

The recommended treatment duration with PEGINTRON combination therapy for patients who failed prior treatment is 48 weeks, regardless of HCV genotype. Retreated patients who have detectable HCV-RNA at week 12 or 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered. '/>"/>

SOURCE Schering-Plough Corporation
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