The first global approval of sofosbuvir was granted by the US FDA on 6 December 2013 [6, 7]
Vosevi is available as tablets containing 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir or 200 mg sofosbuvir, 50 mg velpatasvir and 50 mg voxilaprevir
6, 2013-- Gilead Sciences, Inc
What benefits of Harvoni have been shown in studies? Harvoni has been investigated in three main studies
Sovaldi must be used in combination with other medicines used to treat chronic hepatitis C, such as ribavirin or peginterferon alfa (a form
Posology The recommended dose of Sovaldi in adults is one 400 mg tablet, taken orally, once daily with food (see section 5
FDA Approved: Yes (First approved July 18, 2017) Brand name: Vosevi
2 or 3 randomly received either VOSEVI for 12 weeks or the combination of previously approved drugs called sofosbuvir and velpatasvir for 12 weeks
Generic name: sofosbuvir and velpatasvir
In 2017, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved the fixed-dose direct-acting antiviral (DAA) combination sofosbuvir and ledipasvir and the combination sofosbuvir plus ribavirin for the treatment of adolescents (aged 12–17 years) with chronic hepatitis C
Vosevi FDA Approval History
If the Ledipasvir and sofosbuvir are substrates of drug transporters P-gp and BCRP while GS-331007 is not
The European Medicines Agency (EMA) facilitates development and access to medicines for countries within the European Union (EU)
Approval Letter (s) (PDF) To date, nearly 3,000 patients have received at least one dose of Sovaldi in Phase 2 or 3 studies
Sofosbuvir (tradename Sovaldi) is a direct acting antiviral medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV)
February 10, 2014
3 and as the class 3 compound possess high-solubility and low-permeability ()
Both the Food and Drug Administration (FDA) and European Medicines Agency (EMA) support clinical drug development and accelerated review and authorisation procedures (Box 1)
HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the Saha
A clinical trial comparing 8-week versus 12-week courses of sofosbuvir-ravidasvir for the treatment of chronic hepatitis C, led by the Ministry of Health in Malaysia, is currently ongoing