Data Supporting Boceprevir Response Guided Therapy Presented at American Association for the Study of Liver Diseases (AASLD) Ann
November 01 2009 - 5:00PM
PR Newswire (US)
BOSTON, Nov. 1 /PRNewswire-FirstCall/ -- Schering-Plough
Corporation (NYSE:SGP) today reported two data presentations
supporting response guided therapy with boceprevir combination
therapy in patients with chronic hepatitis C virus (HCV) genotype
1. These retrospective analyses were presented at the American
Association for the Study of Liver Diseases (AASLD) Annual Meeting
in Boston, Oct. 30-Nov. 3. Boceprevir is an investigational HCV
protease inhibitor. Phase III registration studies with boceprevir
in treatment-naïve HCV patients and patients who failed prior
treatment have been fully enrolled and are expected to be completed
in mid-2010. Boceprevir response guided therapy utilizes a unique
4-week lead-in of PEGINTRON(R) (peginterferon alfa-2b) and
REBETOL(R) (ribavirin, USP) prior to the addition of boceprevir
(800 mg TID) for an additional 24-44 weeks. Response guided therapy
is intended to enable the physician to determine the duration of
boceprevir combination therapy based on a patient's viral response
during treatment. Although baseline characteristics cannot predict
which patients may benefit from longer therapy, in-treatment
virologic responses appear likely to do so. The lead-in strategy
allows for an assessment to define a patient's response to
peginterferon and ribavirin alone in this initial 4-week treatment
period. Boceprevir Response Guided Therapy in Null Responder
Patients The boceprevir Phase II HCV SPRINT-1 study in
treatment-naïve patients with HCV genotype 1 had two treatment arms
in which patients received a 4-week lead-in followed by the
addition of boceprevir for an additional 24 or 44 weeks (n=206). In
an oral presentation at AASLD,(1) researchers analyzed results from
these two arms to determine SVR rates in patients who had a null
response to peginterferon and ribavirin therapy (defined as