Philadelphia, April 24, 2015 -- Once-daily oral grazoprevir/elbasvir combination therapy, taken without interferon or ribavirin for 12 weeks, demonstrated high sustained virologic response rates for treatment-naïve patients with cirrhotic or non-cirrhotic chronic hepatitis C virus (HCV) genotype 1, 4, or 6. These findings suggest that once-daily oral grazoprevir/elbasvir represents a new therapeutic option for chronic HCV infection.
Data from the Phase 3 C-EDGE Treatment-Naïve Trial are being presented for the first time at the 50th annual congress of the European Association for the Study of the Liver in Vienna, Austria, and are published today in Annals of Internal Medicine.
In this randomized, blinded, placebo-controlled, parallel-group trial, 412 mono-infected treatment-naïve patients received either immediate or deferred therapy with grazoprevir/elbasvir. Patients in the immediate treatment group took one fixed-dose combination tablet of grazoprevir/elbasvir once daily at approximately the same time for 12 weeks. Patients in the deferred treatment group followed the same regimen but were given matching placebo. Of the 316 patients in the immediate treatment group, 95 percent had undetectable viral load, or sustained viral response, for 12 consecutive weeks (SVR12) after treatment. SVR12 rates were 92 percent for patients with genotype 1a; 99 percent for genotype 1b; 100 percent for genotype 4; and 80 percent for genotype 6. SVR12 was achieved in 97 percent of cirrhotic patients and 94 percent of non-cirrhotic patients.
###
Note: A link to the paper describing these findings will be live at 9:00 a.m. ET on Friday, April 24 http://www.annals.org/article.aspx?doi=10.7326/M15-0785. For an embargoed PDF of the full paper, please contact Megan Hanks at mhanks@acponline.org. The lead study author, Prof. Stefan Zeuzem, may be contacted by the media directly at zeuzem@em.uni-frankfurt.de.
Journal
Annals of Internal Medicine