Phase III C-EDGE trial with Zepatier (elbasvir and grazoprevir) shows superiority to sofosbuvir in hepatitis C infection- Merck

Merck has announced the presentation of results from C-EDGE Head-to-Head, the comparative, Phase III, open-label clinical trial evaluating the efficacy and safety of Zepatier (elbasvir and grazoprevir) 50mg/100mg tablets versus a regimen of sofosbuvir 400mg tablets plus peginterferon and ribavirin (pegIFN/RBV) in treatment-na�ve and pegIFN/RBV treatment-experienced patients with chronic hepatitis C (HCV) genotype (GT) 1 or GT4 infection. In this study, Zepatier demonstrated superiority on efficacy and safety endpoints compared to sofosbuvir plus pegIFN/RBV, based on pre-specified analyses.

In the full analysis set (FAS) (n=255), the efficacy endpoint of sustained virologic response (SVR) 12 weeks after the completion of therapy (SVR12, considered virologic cure) was achieved in 99 percent (128/129) of patients receiving Zepatier for 12 weeks versus 90 percent (114/126) of patients receiving sofosbuvir plus pegIFN/RBV for 12 weeks. The study�s safety endpoint was the frequency of pre-specified (Tier 1) safety events focusing on tolerability, hematologic side effects, and liver-related laboratory abnormalities.

Higher SVR rates were observed among those receiving Zepatier (elbasvir and grazoprevir) in subgroups of patients who had previously experienced a non-response to pegIFN/RBV therapy and in those with cirrhosis, higher baseline viral load, or IL28B non-CC genotype. Efficacy results for the overall population as well as those for selected subgroups are shown in Table 1. In the Zepatier group, one patient (1%) discontinued from the trial after completing treatment. There were no virologic failures in the Zepatier group. In the sofosbuvir plus pegIFN/RBV group, virologic failure occurred in 11 patients (9%) and one patient (1%) discontinued from the trial after the first week of treatment.

Comment: Zepatier � Merck�s once-daily, fixed-dose combination tablet indicated with or without RBV for the treatment of chronic HCV GT1 or GT4 infection in adults � was approved by the FDA on Jan. 28, 2016, based in part on prior studies from the Phase III program.