NEW YORK -- March 11, 2009 -- The US Food and Drug Administration (FDA) has approved a new indication for peginterferon alfa-2b (Pegintron) and ribavirin (Rebetol) combination therapy for treating chronic hepatitis C in patients aged 3 years and older with compensated liver disease.
The approval is based on the results of a noncomparative trial in which 2,293 adult patients with moderate to severe fibrosis or cirrhosis who failed previous treatment with combination peginterferon alfa-2b/ribavirin were retreated with peginterferon alfa-2b 1.5 mcg/kg once weekly in combination with weight-adjusted ribavirin 800 to 1,400 mg daily.
Eligible patients had received at least 12 weeks of combination therapy and included prior nonresponders and prior relapsers.
Overall, previous relapsers, patients with hepatitis C virus (HCV) genotype 2 or 3, or those initially treated with nonpegylated interferon therapy achieved higher rates of sustained virologic response (SVR) than patients with previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, or HCV genotype 1 infection.
"Based on a patient's treatment history, physicians can identify which patients may be right for retreatment with [peginterferon alfa-2b/ribavirin] combination therapy and may have the best chance to achieve a sustained response," said lead investigator Eugene R. Schiff, MD, Center for Liver Diseases, University of Miami Miller School of Medicine, Miami, Florida. "Conversely, patients with certain treatment characteristics who are unlikely to respond to this regimen can be advised accordingly."
The study showed that achievement of undetectable virus (HCV-RNA) at treatment week 12 was a strong predictor of SVR. Patients who still had detectable virus at week 12 of therapy were highly unlikely to achieve SVR.
"Patients with undetectable virus at week 12 have a better chance for success and can be motivated to continue treatment, and those patients who fail to achieve an early response can have their therapy stopped with confidence, thus avoiding unnecessary treatment and potential adverse events," said Dr. Schiff.
The overall response rate in the study was 22% (497/2,293). Response rates among relapsers were 43% (130/300) and 35% (113/344) for patients previously treated with nonpegylated or pegylated alpha interferon and ribavirin combination therapy. The response rates in nonresponders overall were 18% (158/903) and 6% (30/476).
The recommended treatment duration with the 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.
Patients receiving peginterferon alfa-2b/ribavirin combination therapy as retreatment after failing a previous interferon combination regimen reported adverse reactions similar to those previously associated with this regimen during clinical trials of treatment-naïve patients.
SOURCE: Schering-Plough Corporation
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