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% |
| 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.