Tag Archives: SOF/VEL

Sofosbuvir / Velpatasvir submitted for approval in the US

Sofosbuvir / VelpatasvirA New Drug Application for the combination hep C treatment sofosbuvir / velpatasvir (SOF/VEL) was submitted to the U.S. Food and Drug Administration (FDA) yesterday. It was assigned a Breakthrough Therapy designation, which is granted in America to investigational medications that may offer major advances in treatment over current treatment options.

Sofosbuvir / velpatasvir is a pill taken once a day. It is made up of the nucleotide NS5B polymerase inhibitor sofosbuvir, brandname Sovaldi, and velpatasvir, an investigational pan-genotypic NS5A inhibitor. The combination was submitted for approval as a treatment for hep C genotype 1-6 infections.

Sofosbuvir/Velpatasvir Clinical Trial Results
Clinical Trial Patients Treatment Regimen Treatment Duration SVR12
ASTRA-1, -2, -3 Genotypes 1-6, with or without cirrhosis SOF/VEL 12 weeks 98%
ASTRA-4 Genotypes 1-6 all with Child-Pugh class B (decompensated) cirrhosis SOF/VEL with ribavirin 12 weeks 94%
SOF/VEL 12 weeks 83%
24 weeks 86%

The most common side effects experienced during clinical trials were headache, fatigue, and nausea.

Sofosbuvir / velpatasvir is not approved for use in Canada.

More information can be found on the Hepatitis C Treatment Information Project or in Gilead’s News Release.