New analyses from Phase III studies of VICTRELIS to be presented at AASLD 2011

Oct 1 2011

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that several new analyses from Phase III studies of VICTRELIS^™ (boceprevir), the company's first-in-class, oral hepatitis C virus (HCV) NS3/4A protease inhibitor will be presented at the 62^nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). The meeting will be held Nov. 4-8 in San Francisco. Presentations will include results from the Phase III PROVIDE study, which evaluated the efficacy of VICTRELIS in combination with peginterferon alfa and ribavirin in adult patients with chronic HCV genotype 1 infection who had prior null response to treatment with peginterferon alfa and ribavirin alone.

“Merck looks forward to sharing data with the scientific community at this year's AASLD to inform the continuing fight against chronic hepatitis C”

More than 30 abstracts highlighting Merck medicines and investigational therapies for chronic HCV will be presented at AASLD, including four oral presentations and 14 posters for VICTRELIS. One poster has been selected as a Presidential Poster of Distinction.

New data also will be presented on the efficacy and safety of Merck's MK-5172, an investigational once-daily, second-generation oral HCV NS3/4A protease inhibitor, in patients chronically infected with HCV genotypes 1 and 3.

"Merck looks forward to sharing data with the scientific community at this year's AASLD to inform the continuing fight against chronic hepatitis C," said Roger J. Pomerantz, M.D., F.A.C.P., senior vice president, Infectious Diseases, Merck Research Laboratories.

The abstracts were published today and can be accessed on the AASLD website. For program information, please visit https://www.aasld.org.

Key presentations for VICTRELIS

Efficacy of Boceprevir in Patients with Null Responses to Peginterferon/Ribavirin:

The PROVIDE study. Vierling, J. et al. Poster 931. Sunday, Nov. 6, 8:00 a.m. - 5:30 p.m. Moscone West Convention Center Poster Hall

Treatment-Naive Black Patients Treated with Boceprevir Combined with Peginterferon Alfa-2b + Ribavirin: Results from HCV SPRINT-2. McCone, J. et al. Poster 981. Sunday, Nov. 6, 8:00 a.m. - 5:30 p.m.

Analysis of Resistance-Associated Amino Acid Variants (RAVs) in non-SVR Patients Enrolled in a Retrospective Long-Term Follow-Up Analysis of Boceprevir Phase III Clinical Studies. Barnard, R.J.O. et al. Abstract #164. Oral Presentation: Monday, Nov. 7, 3:15 - 3:30p.m., Moscone West Convention Center, Rooms 2001-2003 and 2014-2016

Genotypic and Phenotypic Correlates of Resistance in HCV Genotype 1a and 1b Infected Patients Treated with Boceprevir Plus Peginterferon Alpha and Ribavirin. Ogert, R.A. et al. Poster 927. Sunday, Nov. 6, 8:00 a.m. - 5:30 p.m. Moscone West Convention Center Poster Hall. Selected as a Presidential Poster of Distinction

Other key Merck presentations

IL28B genotype predicted for>10 IU/mL reduction in serum HCV RNA after 4 weeks of peginterferon and ribavirin therapy: implications for the use of the lead-in strategy for DAA-based treatment regimens. Thompson, A.J. et al. Abstract #157. Oral Presentation: Monday, Nov. 7, 3:00 -3:15 p.m., Moscone West Convention Center, Rooms 2006-2008

Safety and Antiviral Activity of MK-5172, a Next Generation HCV NS3/4A Protease Inhibitor with a Broad HCV Genotypic Activity Spectrum and Potent Activity Against Known Resistance Mutants, in Genotype 1 and 3 HCV-Infected Patients. Petry, A. et al. Poster 346. Saturday, Nov. 5, 2:00 p.m. - 7:30 p.m. Moscone West Convention Center Poster Hall

MK-5172, a Second-Generation HCV NS3/4A Protease Inhibitor, is Active against Common Resistance Associated Variants (RAVs) and Exhibits Cross-Genotype Activity. Graham, D. et al. Poster 370. Saturday, Nov. 5, 2:00 p.m. - 7:30 p.m. Moscone West Convention Center Poster Hall

Indications and usage for VICTRELIS

VICTRELIS was approved by the U.S. Food and Drug Administration (FDA) on May 13 for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:

• VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
• VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors. VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
• Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.

SOURCE Merck