The Russian Ministry of Health has issued a registration certificate to the Russian pharmaceutical company Pharmasyntez for a generic drug with the trade name “Velpatasof” (velpatasvir + sofosbuvir). This is the first analogue of the original drug Epclusa of american company Gilead Sciences, intended for the treatment of chronic viral hepatitis C.
The mechanism of action of the drug is based on dual inhibition of viral proteins: sofosbuvir blocks the RNA-dependent RNA polymerase NS5B, and velpatasvir affects the non-structural protein NS5A. This combined approach ensures effective suppression of viral replication and the formation of new virions.
The drus is available in the form of film-coated tablets in a fixed dose of 100 mg velpatasvir and 400 mg sofosbuvir. The drug is included in the list of vital and essential drugs and is indicated for use in patients over 12 years of age with a body weight of 30 kg, while the original drug is approved for use from the age of six with a body weight of 17 kg and is available in two dosages. The registration of the drug was preceded by a clinical bioequivalence study involving 60 healthy volunteers, completed in December 2024.
