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Schering-Plough Reports Potent Antiviral Activity With Narlaprevir (SCH 900518), an Investigational, Once-Daily Protease Inhibitor for Hepatitis C
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Interim results of Phase IIa NEXT-I study presented at American Association
for the Study of Liver Diseases (AASLD) Annual Meeting
Schering Plough press release
BOSTON, Nov. 2 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE:
SGP) today reported that interim results from an ongoing Phase IIa study of
narlaprevir (SCH 900518), its investigational, once-daily protease inhibitor,
demonstrated potent antiviral activity in treatment-naive patients with
chronic hepatitis C virus (HCV) genotype 1. In the lead-in arms of the study,
in which patients received a 4-week lead-in of PEGINTRON(R) (peginterferon
alfa-2b) and REBETOL(R) (ribavirin, USP) followed by the addition of
narlaprevir, 85-87 percent of patients achieved rapid virologic response
(RVR), compared to 58-75 percent of patients in the no lead-in narlaprevir
arms and no patients in the PEGINTRON and REBETOL control arm. RVR, defined in this study as undetectable virus (HCV RNA) at week 4 of narlaprevir
treatment, is recognized as an important predictor for achieving sustained
virologic response. These interim results from the NEXT-1 study were reported
in an oral presentation at the American Association for the Study of Liver
Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.[1]
"These interim results, while preliminary, are very encouraging, and showed
that narlaprevir has potent antiviral activity in hepatitis C," said John
Vierling, M.D., professor of medicine and surgery, chief of hepatology, Baylor
College of Medicine, Houston, and the lead investigator of the study. "In
this study, once-daily narlaprevir greatly improved viral clearance at week 4
of treatment in genotype 1 hepatitis C infection compared to the control
group. We look forward to further results from this ongoing study."
Importantly, patients in the lead-in narlaprevir arms also achieved improved
rates of early virologic response (EVR), defined as undetectable virus at week
12 of treatment, with 85-87 percent of patients having undetectable 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.
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