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Schering-Plough Reports Potent Antiviral Activity With Narlaprevir (SCH 900518), an Investigational, Once-Daily Protease Inhibitor for Hepatitis C
Date:11/2/2009

virus at week 12 of narlaprevir treatment compared to 17 percent of patients at week 12 in the control arm.

Narlaprevir is a next-generation oral HCV protease inhibitor that achieves once-daily dosing through the use of low-dose ritonavir as a metabolic inhibitor. The NEXT-1 study evaluates 12 weeks of narlaprevir 200 mg or 400 mg once-daily or 100 mg twice daily with low-dose ritonavir (100 mg) in combination with PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (600-1400 mg daily), followed by PEGINTRON and REBETOL alone for an additional 12 or 36 weeks (24 or 48 weeks total). The study includes two treatment arms in which patients receive a 4-week lead-in of PEGINTRON and REBETOL prior to receiving narlaprevir 200 mg or 400 mg once-daily in the above regimen. All patients in the narlaprevir arms have completed narlaprevir dosing. The control arm is PEGINTRON and REBETOL alone for 48 weeks.

In this study, the rate of adverse events in the narlaprevir arms was similar to that in the peginterferon and ribavirin control arm, except for an increase in anemia (there were no discontinuations due to anemia) and an increase in low neutrophil counts (with no clinical sequelae). The most frequently seen adverse events up through 12 weeks of treatment were fatigue, nausea, flu-like illness, headache and insomnia. No increase in skin adverse events (rash or pruritus) beyond what was seen in the peginterferon and ribavirin control was observed.

For more information about ongoing narlaprevir clinical studies, please visit www.clinicaltrials.gov.

About Hepatitis C

Hepatitis C is a serious and potentially life-threatening disease. It is the most common blood-borne infection in America and Europe, and the most common form of liver disease, affecting nearly 5 million people in the United States, 5 million in Europe and some 200 million people worldwide. It is the lead
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