MedPath

Velpatasvir

Generic Name
Velpatasvir
Brand Names
Epclusa, Vosevi
Drug Type
Small Molecule
Chemical Formula
C49H54N8O8
CAS Number
1377049-84-7
Unique Ingredient Identifier
KCU0C7RS7Z

Overview

Velpatasvir is a Direct-Acting Antiviral (DAA) medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patients . Velpatasvir acts as a defective substrate for NS5A (Non-Structural Protein 5A), a non-enzymatic viral protein that plays a key role in Hepatitis C Virus replication, assembly, and modulation of host immune responses . Treatment options for chronic Hepatitis C have advanced significantly since 2011, with the development of Direct Acting Antivirals (DAAs) such as velpatasvir. Notably, velpatasvir has a significantly higher barrier to resistance than the first generation NS5A inhibitors, such as Ledipasvir and Daclatasvir, making it a highly potent and reliable alternative for treatment of chronic Hepatitis C . In a joint recommendation published in 2016, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recommend Velpatasvir as first line therapy in combination with sofosbuvir for all six genotypes of Hepatitis C . Velpatasvir is currently only available within a fixed dose combination product as Epclusa with Sofosbuvir, another direct acting antiviral. Goals of therapy for Epclusa include the intent to cure, or achieve a sustained virologic response (SVR), after 12 weeks of daily therapy. SVR and eradication of HCV infection is associated with significant long-term health benefits including reduced liver-related damage, improved quality of life, reduced incidence of Hepatocellular Carcinoma, and reduced all-cause mortality and risk of requiring a liver transplant . Since June 2016, Velpatasvir has been available as a fixed dose combination product with Sofosbuvir, as the commercially available product Epclusa. Epclusa is the first combination HCV product indicated for the treatment of all genotypes of Hepatitis C with or without cirrhosis. It is also currently the most potent HCV antiviral medication on the market with a sustained virologic response (SVR) after 12 weeks of therapy of 93-99% depending on genotype and level of cirrhosis and a high barrier to resistance . Both Canadian and American guidelines list Epclusa as a first line recommendation for all genotypes of HCV .

Background

Velpatasvir is a Direct-Acting Antiviral (DAA) medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patients . Velpatasvir acts as a defective substrate for NS5A (Non-Structural Protein 5A), a non-enzymatic viral protein that plays a key role in Hepatitis C Virus replication, assembly, and modulation of host immune responses . Treatment options for chronic Hepatitis C have advanced significantly since 2011, with the development of Direct Acting Antivirals (DAAs) such as velpatasvir. Notably, velpatasvir has a significantly higher barrier to resistance than the first generation NS5A inhibitors, such as Ledipasvir and Daclatasvir, making it a highly potent and reliable alternative for treatment of chronic Hepatitis C . In a joint recommendation published in 2016, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recommend Velpatasvir as first line therapy in combination with sofosbuvir for all six genotypes of Hepatitis C . Velpatasvir is currently only available within a fixed dose combination product as Epclusa with Sofosbuvir, another direct acting antiviral. Goals of therapy for Epclusa include the intent to cure, or achieve a sustained virologic response (SVR), after 12 weeks of daily therapy. SVR and eradication of HCV infection is associated with significant long-term health benefits including reduced liver-related damage, improved quality of life, reduced incidence of Hepatocellular Carcinoma, and reduced all-cause mortality and risk of requiring a liver transplant . Since June 2016, Velpatasvir has been available as a fixed dose combination product with Sofosbuvir, as the commercially available product Epclusa. Epclusa is the first combination HCV product indicated for the treatment of all genotypes of Hepatitis C with or without cirrhosis. It is also currently the most potent HCV antiviral medication on the market with a sustained virologic response (SVR) after 12 weeks of therapy of 93-99% depending on genotype and level of cirrhosis and a high barrier to resistance . Both Canadian and American guidelines list Epclusa as a first line recommendation for all genotypes of HCV .

Indication

Velpatasvir is used in combination therapy with other antiviral medications to treat chronic hepatitis C virus (HCV) infected patients with HCV genoptypes 1-6, and to treat HCV and HIV co-infected patients. Depending on the level of cirrhosis or decompensation, combination therapy can also include therapy with Ribavirin. When used in combination with Sofosbuvir as the combination product Epclusa, Velpatasvir is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, or in combination with Ribavirin if associated with decompensated cirrhosis .

Associated Conditions

  • Chronic Hepatitis C - Genotype 3
  • Chronic Hepatitis C Genotype 1
  • Chronic hepatitis C genotype 2
  • Chronic hepatitis C genotype 5
  • Genotype 4 Chronic Hepatitis C
  • Genotype 6 chronic hepatitis C infection

FDA Approved Products

Epclusa
Manufacturer:Gilead Sciences, Inc.
Route:ORAL
Strength:50 mg in 1 1
Approved: 2022/04/30
NDC:61958-2203
Epclusa
Manufacturer:Gilead Sciences, Inc.
Route:ORAL
Strength:100 mg in 1 1
Approved: 2022/04/30
NDC:61958-2201
Epclusa
Manufacturer:Gilead Sciences, Inc.
Route:ORAL
Strength:50 mg in 1 1
Approved: 2022/04/30
NDC:61958-2204
Epclusa
Manufacturer:Gilead Sciences, Inc.
Route:ORAL
Strength:37.5 mg in 1 1
Approved: 2022/04/30
NDC:61958-2205
Vosevi
Manufacturer:Gilead Sciences, Inc.
Route:ORAL
Strength:100 mg in 1 1
Approved: 2019/11/21
NDC:61958-2401

Singapore Approved Products

VOSEVI FILM-COATED TABLETS 400MG/100MG/100MG
Manufacturer:Gilead Sciences Ireland UC, Hovione FarmaCiencia, S.A. (Drug product intermediate), Hovione Limited (Drug product intermediate)
Form:TABLET, FILM COATED
Strength:100 mg
Online:Yes
Approved: 2019/05/31
Approval:SIN15705P
EPCLUSA TABLET 400MG/100MG
Manufacturer:Hovione FarmaCiencia, S.A. (Drug product intermediate), Hovione Limited (Drug product intermediate), Patheon Inc., Gilead Sciences Ireland UC, Esteve Quimica S.A. (Drug product intermediate)
Form:TABLET, FILM COATED
Strength:100mg
Online:Yes
Approved: 2017/10/19
Approval:SIN15351P

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