A 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%|
The most common side effects experienced during clinical trials were headache, fatigue, and nausea.
Sofosbuvir / velpatasvir is not approved for use in Canada.