Zepatier Tops Sovaldi Combo in Phase 3 Hepatitis C Trial

During a recent phase 3 trial, elbasvir and grazoprevir (Zepatier) showed superior safety and efficacy endpoints compared with sofosbuvir plus peginterferon and ribavirin (pegIFN/RBV) in the treatment of chronic hepatitis C virus (HCV).

The open-label, phase 3 trial administered 50mg/100mg of Zepatier compared with a regimen of sofosbuvir 400mg tablets plus pegIFN/RBV in treatment-naïve and pegIFN/RBV treatment-experienced patients with HCV genotypes (GT) 1 or 4.

The results of the study showed that 12 weeks after Zepatier treatment was completed, the efficacy endpoint of sustained virologic response was achieved in 99% of patients in that group, compared with 90% of patients in the sofosbuvir pegIFN/RBV cohort.

The safety endpoint was the frequency of pre-specified (Tier 1) safety events that focused on tolerability, hematologic side effects, and liver-related laboratory abnormalities.

“Overall in this study, the elbasvir and grazoprevir regimen showed superior SVR rates and improvement on pre-specified safety endpoints compared to the sofosbuvir plus peginterferon and ribavirin regimen in these genotype 1- or 4-infected patients,” said lead study investigator Jan Sperl in a press release. “Sofosbuvir in combination with peginterferon and ribavirin continues to be a prescribed treatment regimen in many regions, and this comparative study versus combination treatment with elbasvir and grazoprevir provides interesting and important insights.”