Results from two Canadian studies confirm sustained viral response rates seen in hepatitis C patients treated with Pegatron

- Canadian POWeR and REDIPEN(R) Programs presented at the American Association for the Study of Liver Diseases Annual Meeting -

 

KIRKLAND, QC, Nov. 2 /CNW/ - Results from two significant Canadian studies underscore the growing scientific evidence of PEGETRON's positive outcomes in the treatment of chronic hepatitis C virus (HCV) infection. Canadian investigators across the country collaborated to generate and analyze clinical data from the Canadian PEGETRON POWeR (Prospective Optimal Weight-based Dosing Response) and REDIPEN programs, which were presented at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston on November 1, 2009.

The first abstract, Determinants of Virologic Relapse Following Hepatitis C antiviral Therapy: Analysis of the Canadian POWeR Program(1) reports Genotype 1 (G1)-infected patients treated with peginterferon alfa-2b plus weight-based ribavirin (PEGETRON) across 138 Canadian centres, achieved a sustained virologic response (SVR) rate of 39 per cent, consistent with the 40 per cent SVR attained with approved peginterferon alfa-2B/ribavirin (PEGETRON) therapy in the recent United States-based IDEAL Study.(2) In addition, the relapse rate of G1-infected subjects in POWeR was 25 per cent,(1) similar to the 24 per cent reported in the IDEAL Study.(2)

In the second abstract, Outcomes of a Large, Inclusive Population-Based Hepatitis C Treatment Program are similar to Randomized Controlled Trials: Interim Results of the Canadian REDIPEN Program,(3) a heterogeneous, but representative, population of Canadian G1 patients treated with peginterferon alfa 2b plus weight-based ribavirin (PEGETRON) achieved results similar to those treated in randomized, controlled clinical trials. The G1 SVR rate was 39 per cent, consistent with both the above-mentioned Canadian POWeR Program and controlled trials, such as the IDEAL Study. Similar G1 relapse rates were also reported.

"The results from both the Canadian POWeR and REDIPEN programs support previous findings from randomized controlled trials of PEGETRON," said Dr. Curtis Cooper, M.D., Associate Professor of Medicine at the University of Ottawa, Division of Infectious Diseases and first author of both POWeR and REDIPEN presentations. "The encouraging response rates and low relapse rates seen with PEGETRON therapy are consistent across multiple large Canadian and U.S. studies and shed important light on hepatitis C treatment outcomes in real-life clinical practice settings."

These results reinforce the notion that outcomes achieved with PEGETRON across a large number of clinical trials are consistent and could be generalized to real-life clinical practice.(3)

The Future of Hepatitis C Therapy

In addition to the POWeR and REDIPEN studies, clinical trial data for Schering-Plough's investigational HCV protease inhibitors boceprevir and narlaprevir (SCH 900518) were presented at AASLD. Researchers analyzed data from the Phase II HCV SPRINT-1 study to determine SVR rates with boceprevir triple combination therapy in treatment-naive HCV genotype 1 patients who had a null response to peginterferon and ribavirin (defined as less than 1 log decrease in HCV viral load) after a four-week lead-in period prior to the addition of boceprevir to the regimen. Overall, 38 percent of null responders achieved SVR (19/50), with 25 percent (7/28) of patients who received 28 weeks of therapy and 55 percent (12/22) of patients who received 48 weeks of therapy achieving SVR. Patients with null response to peginterferon and ribavirin are considered to be among the most difficult to treat successfully and historically achieve a low rate of SVR.(4)

Phase III registration studies with boceprevir, in combination with peginterferon and ribavirin, in both treatment-naïve HCV patients and patients who failed prior treatment have been fully enrolled and are expected to be completed in mid-2010. The safety and efficacy of boceprevir are still under investigation and market authorization has not yet been obtained.

A presentation on narlaprevir, a next-generation once-daily HCV protease inhibitor, reported week-4 rapid virologic response (RVR) and week-12 early virologic response (EVR) data in treatment-naïve HCV genotype 1 patients from the ongoing NEXT-1 Study. Narlaprevir is currently in Phase II clinical development.(5) The safety and efficacy of narlaprevir are still under investigation and market authorization has not yet been obtained.

"We are excited and look forward to the future availability of investigational molecules currently in the trial phase," said Dr. Frank Anderson, M.D. FRCP(C), of the LAIR Centre in Vancouver, and a co-author on the boceprevir HCV SPRINT-1 Study abstract. "New direct antiviral agents such as boceprevir offer the prospect of a new standard of care, with the potential for a response guided therapy approach to treatment. The encouraging results provide real hope for people with hepatitis C."

Hepatitis C is a serious and potentially life-threatening chronic liver disease caused by the hepatitis C virus (HCV). An estimated 250,000 people in Canada are infected with HCV, and between 3,200 and 5,000 individuals are newly infected with HCV each year.(6) It is the leading cause of liver transplants in Canada.(7)

About Schering-Plough

Schering-Plough Canada Inc. is a country operation of Schering-Plough Corporation that employs more than 1000 people across Canada. Schering-Plough Canada Inc.'s Web site is www.schering-plough.ca<http://www.schering-plough.ca>.

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com<http://www.schering-plough.com>.

 

References:

(1) C. Cooper et al. 60th Annual Meeting of the AASLD, October 30- November 3, 2009, Boston, MA (Poster No.820). (2) JG McHutchison et al. N Engl J Med. 2009;361:580-93 (3) C. Cooper et al. 60th Annual Meeting of the AASLD, October 30- November 3, 2009, Boston, MA (Poster No.850). (4) Schering-Plough press release. Schering-Plough Highlights Boceprevir, Narlaprevir (SCH 900518) and PEGINTRON(R) Data at the American Association for the Study of Liver Diseases (AASLD) 2009 Annual Meeting. October 15, 2009. (5) Ibid. (6) Health Canada. http://www.phac-aspc.gc.ca/hepc/pubs/getfacts-informezvous/index-eng.php Accessed October 28, 2009. (7) Canadian Liver Foundation. http://www.liver.ca/Liver_Disease/ Accessed October 28, 2009.

 

(R) PEGETRON is a registered trademark of Schering-Plough Ltd., used under license by Schering-Plough Canada Inc.

(R)REDIPEN is a registered trademark of Schering-Plough Canada Inc.

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For further information: Media Contacts: Mona Aubin, Schering-Plough Canada, mona.aubin@spcorp.com

Posted: November 2009

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