AASLD-Phase III all-oral hepatitis C regimen daclatasvir and asunaprevir to be presented

 

All-oral, Combination Therapy for Patients with Hepatitis C Provides High Sustained Virologic Response Rate

Presented: November 5, 2013
Walter E. Washington Convention Center, Washington, DCWASHINGTON

Nov. 4, 2013 /PRNewswire/ -- In this abstract to be presented at the annual meeting of the American Association for the Study of Liver Diseases, researchers from Japan provided 12-week results from their phase III study of an all-oral treatment regimen. In their presentation at The Liver Meeting® they will also provide 24-week results.

The group administered a combined treatment of daclatasvir and asunaprevir. The treatment did not include peg-interferon/ribavirin. The treatment group were infected with hepatitis C genotype 1b, and they were either ineligible, naive or intolerant to treatment with peginterferon/ribavirin or they were nonresponders to such treatment.

For the 24-week study, 222 patients were studied, and 85.6 percent of those patients had a sustained virologic response (SVR) by week 12. According to Kazuaki Chayama, MD, PhD, "Only around 75 percent of patients treated with peg-interferon /ribavirin/telaprevir had a SVR but that therapy was associated with severe side effects and high cost. New oral-only drug therapy is quite safe and the eradication rate is so high."

Dr. Chayama continues, "These results, which were quite amazing, were expected after conducting the phase II trial, and we are very happy to confirm them in the phase III trial. I think further development of direct acting antivirals (DAAs) such as polymerase inhibitors will improve the SVR even more. Further research is necessary to develop an even higher SVR rate -- possibly 100 percent. Combination therapy with polymerase inhibitors is one way. Combination of these DAAs with peg-interferon (or interferon lambda) with or without ribavirin should be considered for patients with multi-drug resistance."

It was also noted that response rate was independent of baseline factors such as gender, age, baseline HCV RNA, etc. Although no death occurred during the study, 26 patients discontinued treatment due to adverse events or lack of efficacy.

Abstract title:

All-oral Combination of Daclatasvir Plus Asunaprevir in Interferon Ineligible Naive/Intolerant and Nonresponder Japanese Patients Chronically Infected with HCV Genotype 1b: Results from a Phase 3 Trial

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 Washington, November 2-5, will bring together more than 9,000 researchers from 55 countries.

A pressroom will be available from November 1 at the annual meeting. For copies of abstracts and press releases, or to arrange researcher interviews, contact Gregory Bologna at 703-299-9766.

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