BEERSE, Belgium, May 31, 2013 /PRNewswire/ —
(Janssen) announced today that the European Commission (EC) has
approved a new twice daily (BID) dosing of INCIVO® (telaprevir), a
direct acting antiviral (DAA) protease inhibitor, in combination with
pegylated-interferon and ribavirin (PR) for naive and previous treatment
experienced patients. The newly approved dosing regimen for INCIVO® is
now 1,125 mg twice daily in combination with PR, which aligns a morning
and evening dose to the already twice daily dosing schedule for
ribavirin versus 750 mg every 8 hours in combination with PR.
approval is based on results from OPTIMIZE, a randomized, open-label,
multicenter Phase III study in treatment naive patients with genotype-1
chronic HCV infection, which demonstrated that twice daily dosing of
INCIVO® 1,125mg in combination with PR was non-inferior to the
previously approved dosing every 8 hours in the proportion of patients
who achieved sustained virologic response (74% versus 73%). Twice daily dosing also showed similar cure rates with twice daily or every 8 hours INCIVO dosing in patients with cirrhosis.