Sofosbuvir/velpatasvir

Sofosbuvir/velpatasvir
Combination of
SofosbuvirNS5B polymerase inhibitor
VelpatasvirNS5A inhibitor
Clinical data
Trade namesEpclusa, Sofosvel, Velpanat, others
AHFS/Drugs.comMonograph
MedlinePlusa616034
License data
Pregnancy
category
Routes of
administration		By mouth[2]
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
UNII
KEGG

Sofosbuvir/velpatasvir, sold under the brand name Epclusa among others, is a fixed-dose combination medication for the treatment of hepatitis C in adults.[2][5][6][7] It combines sofosbuvir and velpatasvir.[2][5][6] It is more than 90% effective for hepatitis C genotypes one through six.[2] It also works for hepatitis C in those who also have cirrhosis or HIV/AIDS.[2] It is taken by mouth.[2][5][6]

In March 2020, sofosbuvir/velpatasvir was approved for use in the United States to treat hepatitis C virus (HCV) in children ages six years and older or weighing at least 37 pounds (17 kilograms) with any of the six HCV genotypes—or strains—without cirrhosis (liver disease) or with mild cirrhosis. Sofosbuvir/velpatasvir in combination with ribavirin is indicated for the treatment of children six years and older or weighing at least 37 pounds with severe cirrhosis.[8]

The combination is generally well tolerated.[2] Common side effects include headaches, fatigue, trouble sleeping, and nausea.[9][8] The combination has not been studied in pregnant women or during breastfeeding.[9] Greater care is required in those who are also infected with hepatitis B.[9] Sofosbuvir works by blocking the NS5B protein and velpatasvir works by blocking the NS5A protein.[9]

Sofosbuvir/velpatasvir was approved for medical use in the United States and in Europe in 2016.[9][6][7] It is on the World Health Organization's List of Essential Medicines.[10]

  1. ^ "Sofosbuvir / velpatasvir (Epclusa) Use During Pregnancy". Drugs.com. Archived from the original on 14 December 2017. Retrieved 13 December 2017.
  2. ^ a b c d e f g "Sofosbuvir/Velpatasvir for the treatment of Hepatitis C" (PDF). WHO. Archived (PDF) from the original on 29 August 2021. Retrieved 29 June 2017.
  3. ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  4. ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
  5. ^ a b c d "Epclusa 400 mg/100 mg film coated tablets. - Summary of Product Characteristics (SmPC)". (emc). 4 November 2019. Archived from the original on 2 March 2020. Retrieved 1 March 2020.
  6. ^ a b c d e "Epclusa- velpatasvir and sofosbuvir tablet, film coated". DailyMed. 21 November 2019. Archived from the original on 16 March 2020. Retrieved 1 March 2020.
  7. ^ a b c "Epclusa EPAR". European Medicines Agency (EMA). 27 February 2020. Archived from the original on 2 March 2020. Retrieved 1 March 2020.
  8. ^ a b "FDA Approves New Treatment for Pediatric Patients with Any Strain of Hepatitis C". U.S. Food and Drug Administration (FDA) (Press release). 19 March 2020. Archived from the original on 19 March 2020. Retrieved 19 March 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ^ a b c d e "Sofosbuvir and Velpatasvir". The American Society of Health-System Pharmacists. Archived from the original on 14 December 2017. Retrieved 8 December 2017.
  10. ^ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.