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C-EDGE: Grazoprevir/elbasvir regimen yields high SVR rates in patients with HCV

VIENNA — Grazoprevir and elbasvir combination therapy produced high sustained virologic response rates among patients with hepatitis C virus infection, according to data presented at the 2015 International Liver Congress.

Stefan Zeuzem, MD, department of medicine, Goethe University Hospital, Frankfurt, Germany, and colleagues randomly assigned 421 treatment-naive patients with and without cirrhosis to receive either a combinations fixed-dose of  100 mg of grazoprevir and  50 mg of elbasvir (MK-5172, MK-8742; Merck; n=316) or placebo (n=105) once daily for 12 weeks. The patients included had either HCV genotype 1, 4 or 6 infection, according to the presentation.

“The results of this study are consistent with those from the grazoprevir and elbasvir clinical study program, in which SVR12 rates of 94% to 100% were achieved in diverse patient populations,” Zeuzem said during his presentation.

Overall, 95% of patients in the combination therapy group achieved a sustained virologic response at 12 weeks (SVR12). At 4 weeks, 97% of patients in the combination group had achieved SVR.

Ninety-two percent of patients with HCV genotype 1a reached SVR12, as well as 99% of patients with HCV genotype 1b, 100% of patients with HCV genotype 4 and 80% of patients with HCV genotype 6. One patient with HCV genotype 1a experienced virologic breakthrough at 8 weeks and 12 patients relapsed (nine with genotype 1a, one with genotype 1b, two with genotype 6).

Less than 5% of patients in the combination therapy group experienced severe adverse events. The most common adverse events were headache, fatigue, nausea and arthralgia. No serious drug-related adverse events were observed. Two patients died for reasons unrelated to the drug combination.

“Grazoprevir and elbasvir were generally well-tolerated, with a similar safety profile in cirrhotic and non-cirrhotic patients,” Zeuzem said. – by Melinda Stevens

For More Information:

Zeuzem S. Abstract G07. Presented at: International Liver Congress; April 22-26, 2015; Vienna.

Disclosure: Zeuzem reports consulting for AbbVie, Bristol-Myers Squibb, Gilead, Janssen and Merck; giving sponsored lectures for AbbVie, Bristol-Myers Squibb, Gilead, Janssen and Merck; and being an investigator for Merck. Please see the study for a full list of other authors’ relevant financial disclosures.

Editor's note: This article has been updated to reflect additional data from the presenter.