Schering-Plough Highlights Boceprevir, Narlaprevir (SCH 900518) And PEGINTRON(R) Data At The American Association For The Study Of Liver Diseases
16 Oct 2009 Schering-Plough announced that data on boceprevir, an investigational hepatitis C virus (HCV) protease inhibitor, will be reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.
Researchers will present sustained virologic response (SVR) data on boceprevir triple combination therapy in treatment-naive HCV genotype 1 patients who had a null response to peginterferon and ribavirin (defined as <1 log decrease in HCV viral load) in the 4-week lead-in arms of the Phase II SPRINT-1 study. Patients with null response to peginterferon and ribavirin are considered to be among the most difficult to treat successfully.
Phase III registration studies with boceprevir in treatment-naive HCV patients and those who failed prior treatment have been fully enrolled and are expected to be completed in mid-2010.
In addition, a late-breaker oral presentation on narlaprevir (SCH 900518), a next-generation once-daily HCV protease inhibitor, will report week-4 rapid virologic response (RVR) and week-12 early virologic response (EVR) data in treatment-naive HCV genotype 1 patients from the ongoing NEXT-1 study. Narlaprevir is currently in Phase II clinical development.
Several presentations will report results with PEGINTRON(R) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy, an approved treatment regimen for chronic hepatitis C. These include a late-breaker oral presentation on a genome-wide analysis of patients from the IDEAL study that identified the first genetic marker that may predict a patient's response to peginterferon and ribavirin combination therapy for hepatitis C. Peginterferon and ribavirin are expected to remain the backbone of HCV treatment regimens for the next several years. Schering-Plough is in the process of analyzing options for the development of a genetic test based on this marker and for making it widely accessible to providers, patients and diagnostic companies for the advancement of science and for helping physicians and patients make more informed treatment decisions.
Hepatitis C is the most common blood-borne infection in America and the most common form of liver disease, affecting nearly 5 million people in the United States and 200 million people worldwide. It is the leading cause of cirrhosis and liver cancer, and the number one reason for liver transplants in the United States and Europe.
This document is intended for trade media attending AASLD for their planning purposes.
Key Data Presentations at AASLD 2009
Boceprevir Oral Presentation
High Sustained Virologic Response (SVR) in Genotype 1 (G1) Null Responders to Peg-Interferon alfa-2b plus Ribavirin When Treated with Boceprevir Combination Therapy; P.Y. Kwo et al. Abstract 62. Sunday, Nov. 1, 5:00 pm to 5:15 pm, Hynes Auditorium
Boceprevir Poster Presentations
Response-Guided Therapy (RGT) for Boceprevir Combination Treatment - Results from HCV SPRINT-1; P.Y. Kwo et al. Abstract 1582. Tuesday, Nov. 3, 8:00 am to 1:00 pm, Hynes Exhibit Hall C
Clonal analysis of mutations selected in the HCV NS3 protease domain of genotype 1 non-responders sequentially treated with boceprevir and/or pegylated interferon alfa-2b; J. Vermehren et al. Abstract 1592. Tuesday, Nov. 3, 8:00 am to 1:00 pm, Hynes Exhibit Hall C
Narlaprevir (SCH 900518) Late-Breaker Oral Presentation Once-Daily Narlaprevir (SCH 900518) in Combination with PEGINTRON (Peginterferon alfa-2b)/ Ribavirin) for Treatment-Naive Subjects with Genotype-1 CHC: Interim Results from NEXT-1, a Phase 2a Study; J.M. Vierling et al. Abstract LB4. Monday, Nov. 2, 5:30 pm to 5:45 pm, Hynes Auditorium
Narlaprevir (SCH 900518) Poster Presentation
SVR Results in Chronic Hepatitis C Genotype 1 Patients Dosed with SCH 900518 and Peginterferon Alfa-2b for 2 Weeks, Followed by Peginterferon Alfa-2b and Ribavirin for 24/48 Weeks: An Interim Analysis; J. de Bruijne et al. Abstract 1555. Tuesday, Nov. 3, 8:00 am to 1:00 pm, Hynes Exhibit Hall C
IDEAL Study Late-Breaker Oral Presentation
Genome-wide analysis of patients from the IDEAL study identifies a polymorphism upstream of the IL28B gene that is strongly associated with SVR in patients with HCV-1; A.J. Thompson et al. Abstract LB5. Monday, Nov. 2, 5:45 pm to 6:00 pm, Hynes Auditorium
IDEAL Study Oral Presentation
Relationship of the Use of Statins and Elevated Low-Density Lipoprotein (LDL) or Total Cholesterol (TC) to Virologic Response in Patients Treated for Hepatitis C Virus (HCV) in the IDEAL Study; S.A. Harrison et al. Abstract 120. Monday, Nov. 2, 4:15 pm to 4:30 pm, Hynes Ballroom B
IDEAL Study Poster Presentation
Analysis of Reasons for Treatment Ineligibility in the IDEAL study: African Americans (AA) vs. non-African Americans (non-AA); M. Melia et al. Abstract 848. Sunday, Nov. 1, 8:00 am to 5:30 pm, Hynes Exhibit Hall C
PEGINTRON Oral Presentation
Interim analysis of a controlled trial of pre-transplant peginterferon alfa-2b/ribavirin (PEG/RBV) to prevent recurrent hepatitis C virus (HCV) infection after liver transplantation (LT) in the Adult-to-Adult Liver Transplantation (A2ALL) Study; G.T. Everson et al. Abstract 1. Sunday, Nov 1, 8:00 am to 8:15 am, Hynes Auditorium
Source: Schering-Plough
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