Sofosbuvir/velpatasvir

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Sofosbuvir/velpatasvir
Combination of
Sofosbuvir NS5B polymerase inhibitor
Velpatasvir NS5A inhibitor
Clinical data
Synonyms Epclusa, Sofosvel, Velpanat, others
AHFS/Drugs.com Monograph
License data
Pregnancy
category
  • AU: B1[1]
  • US: Not assigned[1]
Routes of
administration
By mouth[2]
ATC code
Legal status
Legal status
Identifiers
PubChem CID
KEGG

Sofosbuvir/velpatasvir, sold under the brand name Epclusa among others, is a fixed dose combination medication for the treatment of hepatitis C.[2] It combines sofosbuvir and velpatasvir.[2] 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]

The combination is generally well tolerated.[2] Common side effects include headaches, feeling tired, trouble sleeping, and nausea.[3] It has not been studied in pregnant women or during breastfeeding.[3] Greater care is required in those who are also infected with hepatitis B.[3] Sofosbuvir works by blocking the NS5B protein and velpatasvir works by blocking the NS5A protein.[3]

Sofosbuvir/velpatavir was approved for medical use in the United States in 2016.[3] It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.[4] As of 2017, in the United States a course of treatment costs about 74,800 USD while in the developing world it costs about 900 USD.[2]

Medical uses[edit]

A single tablet regimen is used for adults with genotype 1–6 chronic hepatitis C virus (HCV) infection.[5]

Contraindications[edit]

Combining velpatasvir/sofosbuvir with strong inducers of the liver enzymes CYP2B6, CYP2C8 or CYP3A4, or with P-glycoprotein, is contraindicated because such substances may reduce the effectiveness of the hepatitis C drug.[6]

Side effects[edit]

Common side effects (in more than 10% of people) are headache, fatigue and nausea. In studies, severe side effects were experienced in 3% of patients, and 0.2% terminated the therapy because of adverse events. These effects occurred with similar frequencies in people treated with placebo.[6]

Interactions[edit]

Pharmacokinetics[edit]

History[edit]

Beacon Pharmaceuticals, Bangladesh, introduced a generic version product under the trade name of Sofosvel. Beacon got approval from the Directorate of Drug Administration, Ministry of Health and Family Welfare, People's Republic of Bangladesh.[7] Other Indian companies with similar licenses are expected to follow.[8]

Velpatasvir/sofosbuvir was developed by the pharmaceutical company Gilead Sciences and approved by US FDA in June 2016.[9] In the European Union it was approved on 6 July 2016 for the treatment of chronic hepatitis C virus infection in adults.[10]

References[edit]

  1. ^ a b "Sofosbuvir / velpatasvir (Epclusa) Use During Pregnancy". Drugs.com. Retrieved 13 December 2017. 
  2. ^ a b c d e f g h "Sofosbuvir/Velpatasvir for the treatment of Hepatitis C" (PDF). WHO. Retrieved 29 June 2017. 
  3. ^ a b c d e "Sofosbuvir and Velpatasvir". The American Society of Health-System Pharmacists. Retrieved 8 December 2017. 
  4. ^ "WHO Model List of Essential Medicines (20th List)" (PDF). World Health Organization. March 2017. Retrieved 29 June 2017. 
  5. ^ FDA Approves Epclusa, Drugs.com
  6. ^ a b Haberfeld, H, ed. (2016). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. Epclusa 400 mg/100 mg Filmtabletten. 
  7. ^ US’ Gilead faces competition from Bangladesh’s Beacon pharma, The Economic Times
  8. ^ http://esofosbuvir.com/sofosvel-generic-hepatitis-c-medicine-genotypes/
  9. ^ "FDA approves Epclusa for treatment of chronic Hepatitis C virus infection". Retrieved 14 July 2016. 
  10. ^ "Epclusa". European Medicines Agency. 28 July 2016.