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Zepatier shows high efficacy in hard-to-treat HCV populations

BARCELONA — In this exclusive video interview at the International Liver Congress, Jan Sperl, MD, of the Institute for Clinical and Experimental Medicine, Prague, Czech Republic, discusses results of the C-EDGE Head-to-Head clinical trial where Zepatier showed higher efficacy and sustained virologic response rates compared with Sovaldi, pegylated interferon alpha 2b plus ribavirin in patients with hepatitis C virus infection.

“This study demonstrated superior efficacy of the [elbasvir/grazoprevir] combination especially in patients considered difficult-to-treat with interferon-based regimens,” Sperl told HCV Next. “I think the results of this trial will be useful. … Now we have a direct comparison of these two regimens.”

In the Head-to-Head trial, researchers randomly assigned 255 patients with HCV genotypes 1a, 1b and 4 to receive either a regimen of Zepatier (elbasvir/grazoprevir, Merck; n = 129) or Sovaldi (sofosbuvir, Gilead Sciences) with pegylated interferon alpha 2b and ribavirin (n = 126) for 12 weeks. One-quarter of the patients were treatment-experienced, 17% had compensated cirrhosis and 82% had HCV genotype 1b.

All patients completed the study and are currently in follow-up. Preliminary results at 4 weeks of follow-up show SVR rates of 99.2% in patients treated with elbasvir/grazoprevir and 89.7% in patients treated with sofosbuvir/pegylated interferon alpha 2b/ribavirin.

Sperl said there were a lot of side effects associated with interferon and ribavirin in the trial.

“I think it is important this efficacy was demonstrated in our European populations. We need to accelerate the spread of interferon-free regimens,” Sperl said.

Disclosure: Sperl reports financial relationships with AbbVie, Gilead Sciences, Janssen Cilag and Merck.