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Final Results of Clinical Trial on Boceprevir

Update: Victrelis (boceprevir) Now FDA Approved - May 13, 2011

Presented: Tuesday, 2 November 2010, 9:15 am
BOSTON, Nov. 1, 2010 /PRNewswire/ -- The final results of the RESPOND-2 trial demonstrated that combination therapy with Boceprevir yields higher sustained virologic response (SVR) rates for patients with hepatitis C virus (HCV) genotype 1 who did not respond to or relapsed after treatment with peginterferon alpha 2b and Ribavirin.

"We are excited to have new therapies for treatment of HCV patients who failed to respond to treatment," said Bruce Bacon, MD. "Triple therapy appears to be a significant advance in the fight against hepatitis C."

Three arms were randomly selected from 403 HCV genotype 1 patients who previously failed treatment–partial / non-responders or relapsers:

Control arm received peginterferon alpha 2b and Ribavirin for 48 weeks
Second arm received 4 weeks of lead-in therapy of peginterferon alpha 2b and Ribavirin followed by response-guided therapy of peginterferon alpha 2b and Ribavirin combined with 800 mg of Boceprevir three times a day
Third arm received 4 weeks of lead-in therapy of peginterferon alpha 2b and Ribavirin followed by 44 weeks of peginterferon alpha 2b and Ribavirin combined with 800 mg of Boceprevir

At 24 weeks after conclusion of treatment, the control arm achieved a SVR of 21 percent. Adding Boceprevir to the treatment increased SVR to 59 percent for the second arm and 67 percent for the third arm. It was noted that previous relapsers fared better than nonresponders in all arms. The therapy was well-tolerated, and the most common reason for discontinuing treatment was for patients who still had detectable HCV-RNA at week 12.

"Patients who previously failed to respond to treatment now have a hope for viral eradication," added Dr. Bacon.

Abstract title:

HCV RESPOND-2 Final Results: High Sustained Virologic Response Among Genotype 1 Previous Non-Responders and Relapsers to peginterferon alpha 2b/Ribavirin when Re-Treated with Boceprevir Plus peginterferon alpha 2b/Ribavirin.

About the AASLD

AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases. This year's Liver Meeting®, held in Boston, Massachusetts, October 29-November 2, will bring together more than 7,500 researchers from 55 countries.

A pressroom will be available from October 30 at the annual meeting. For copies of abstracts and press releases, or to arrange for pre-conference research interviews contact Gregory Bologna at 703-299-9766. To pre-register, call Ann Haran at 703-299-9766.

Press releases and all abstracts are available online at www.aasld.org.

This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit http://www.XpressPress.com.

Media Contact: Gregory Bologna



Press Room: October 30 – November 2, 2010

Hynes Convention Center, Room 208

Telephone: 617-954-3106

Researcher: Bruce Bacon, MD

Email: baconbr@slu.edu

Phone: 314-577-8764



SOURCE American Association for the Study of Liver Diseases (AASLD)

Posted: November 2010

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