|Sofosbuvir||NS5B polymerase inhibitor|
|Synonyms||Epclusa, Sofosvel, Velpanat, others|
Sofosbuvir/velpatasvir, sold under the brand name Epclusa among others, is a fixed dose combination medication for the treatment of hepatitis C. It combines sofosbuvir and velpatasvir. It is more than 90% effective for hepatitis C genotypes one through six. It also works for hepatitis C in those who also have cirrhosis or HIV/AIDS. It is taken by mouth.
The combination is generally well tolerated. Common side effects include headaches, feeling tired, trouble sleeping, and nausea. It has not been studied in pregnant women or during breastfeeding. Greater care is required in those who are also infected with hepatitis B. Sofosbuvir works by blocking the NS5B protein and velpatasvir works by blocking the NS5A protein.
Sofosbuvir/velpatavir was approved for medical use in the United States in 2016. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. 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.
A single tablet regimen is used for adults with genotype 1–6 chronic hepatitis C virus (HCV) infection.
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.
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.
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. Other Indian companies with similar licenses are expected to follow.
Velpatasvir/sofosbuvir was developed by the pharmaceutical company Gilead Sciences and approved by US FDA in June 2016. In the European Union it was approved on 6 July 2016 for the treatment of chronic hepatitis C virus infection in adults.
- "Sofosbuvir / velpatasvir (Epclusa) Use During Pregnancy". Drugs.com. Retrieved 13 December 2017.
- "Sofosbuvir/Velpatasvir for the treatment of Hepatitis C" (PDF). WHO. Retrieved 29 June 2017.
- "Sofosbuvir and Velpatasvir". The American Society of Health-System Pharmacists. Retrieved 8 December 2017.
- "WHO Model List of Essential Medicines (20th List)" (PDF). World Health Organization. March 2017. Retrieved 29 June 2017.
- FDA Approves Epclusa, Drugs.com
- Haberfeld, H, ed. (2016). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. Epclusa 400 mg/100 mg Filmtabletten.
- US’ Gilead faces competition from Bangladesh’s Beacon pharma, The Economic Times
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- "Epclusa". European Medicines Agency. 28 July 2016.