Eight weeks of grazoprevir/elbasvir may benefit patients with low fibrosis

SAN FRANCISCO — Eight weeks of therapy with grazoprevir and elbasvir may be effective in patients with low fibrosis scores, according to findings presented at The Liver Meeting 2015.

Lawrence Serfaty, MD, of Saint-Antoine Hospital in Paris, France, and colleagues, compared efficacy rates for 8 and 12 weeks of therapy in treatment-naive, noncirrhotic patients with HCV genotype 1b. “This therapy is one pill,” Serfaty said. “The drug is approved for 12 weeks but we looked at 8 weeks.”

There were 203 patients included in the pooled analysis of the C-WORTHY and C-EDGE trials. Sixty-one patients were randomly assigned 8 weeks of treatment with grazoprevir/elbasvir (Merck), while 142 were treated for 12 weeks.

SVR12 served as the primary endpoint. “This was a retrospective analysis,” Serfaty said.

Evaluation at end of treatment in both the 8- and 12-week arms revealed that 100% of patients reached HCV RNA less than the lower limit of quantification.

SVR12 rates were higher than 90% in both treatment groups.

Two patients in each 8-week treatment arm relapsed by 12 weeks after therapy, and one patient in the 12-week treatment arm relapsed at this time point.

None of the four failures among patients treated for 8 weeks failed with a treatment-emergent NS3 resistance-associated variant (RAV). One of those patients had a treatment-emergent NS5A RAV.

Two patients who were treated for 12 weeks failed. One of those patients had a treatment-emergent NS3 RAV and one had a treatment-emergent NS5A RAV.

“We looked for the reasons for treatment failures,” Serfaty said. “We found that it was fibrosis.”

He added that patients treated for 8 weeks who had F3 fibrosis did worse than those who were F0 to F2.

“There is no impact of HCV RNA alone or NS5A variance alone,” Serfaty said. – by Rob Volansky

Reference:

Serfaty L, et al. Abstract 701. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.

Disclosures: Serfaty reports being on the advisory committees or review panels of AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, MSD and Roche and speaking and teaching for Aptalis.