Exviera, Viekirax regimen shows high SVR in HCV genotype 1b after 8 weeks
New data from the GARNET study — presented today in Paris at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure — showed 98% of patients with hepatitis C virus genotype 1b infection without cirrhosis achieved sustained virologic response 12 weeks after treatment with Exviera plus Viekirax without ribavirin, with some showing high rates after 8 weeks.
“Viekirax and Exviera has already achieved high cure rates with 12 weeks of treatment,” Stefan Zeuzem, MD, chief of the department of medicine, J.W. Goethe University Hospital. Frankfurt, Germany, said in a press release. “These results now show the potential for cure in just 8 weeks with Viekirax [plus] Exviera in HCV genotype 1b-infected patients without liver cirrhosis.”
In the phase 3b trial, Zeuzem and colleagues, including HCV Next Editorial Board member Jordan Feld, MD, Toronto Center for Liver Disease, University of Toronto, enrolled 166 treatment-naive patients from 20 clinical sites. Of these, 163 had chronic HCV genotype 1b without cirrhosis and were included in the study. Three patients were excluded because of other HCV genotypes present.
The primary endpoint was SVR 12 weeks after treatment with Viekirax (ombitasvir/paritaprevir/ritonavir, AbbVie) once daily and Exviera (dasabuvir, AbbVie) twice daily.
One hundred sixty patients achieved SVR at 12 weeks’ posttreatment (98%), with only one patient discontinuing treatment due to adverse events. Two patients experienced posttreatment relapse, and one discontinued due to noncompliance. The most common adverse events were headache (21%) and fatigue (17%). Less than 1% of patients experienced serious adverse events or clinically significant laboratory abnormalities, according to the release. Early results showed 70 patients reached SVR4, according to the abstract.
“The efficacy in this population is particularly important as genotype 1b is the most common subtype of hepatitis C virus globally,” Zeuzem said.
The researchers concluded: “High SVR4 rates were demonstrated in patients with HCV [genotype] 1b infection without cirrhosis following 8-week, [ribavirin]-free treatment with the 3D regimen. Treatment was well-tolerated, with most [adverse events] being mild in severity.”
Welzel T, et al. Abstract #163. Presented at: EASL Special Conference: New Perspectives in Hepatitis C Virus Infection — The Roadmap for Cure; Sept. 23-24, 2016; Paris.
Disclosures: Zeuzem reports serving as a consultant for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen and Merck/MSD. Feld reports receiving grants from AbbVie, Boehringer Ingelheim, Gilead Sciences, Janssen, Merck, and Regulus; and consulting for AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, and Merck. Please see the abstract for a list of all other authors’ relevant financial disclosures.