What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Epclusa (Sofosbuvir and Velpatasvir)
Generic Equivalent - Epclusa (Sofosbuvir and Velpatasvir)
Prescription Required
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Product Details
Description
EPCLUSA is a medication prescribed to treat chronic hepatitis C (HCV) infection. It can treat HCV genotypes 1, 2, 3, 4, 5, or 6. It can also be used to treat people with or without cirrhosis of the liver. There is no EPCLUSA generic available at this time.
Hepatitis C is an infection of the liver caused by HCV. During hepatitis, the liver cells become inflamed and may be killed by the action of HCV. Hepatitis C can remain undetected for years with or without a person's knowledge. Once reactivated, it causes acute hepatitis C, which may become chronic or go away on its own.
When a person has hepatitis C for a long period, they may develop cirrhosis, which is scarring on parts of the liver.
Directions
Take 1 tablet of EPCLUSA (velpatasvir 100 mg/sofosbuvir 400 mg) by mouth once daily with or without food.
How long you take EPCLUSA and whether you take it in combination with other drugs will depend on whether or not you have cirrhosis and how severe it is.
The recommended regimens and durations are:
- No cirrhosis or compensated cirrhosis (Child-Pugh A): EPCLUSA alone for 12 weeks
- Decompensated cirrhosis (Child-Pugh B and C): EPCLUSA and ribavirin for 12 weeks
Your regimen may vary from the above depending on factors that are specific to you. Do not take EPCLUSA differently than how your doctor or treatment team has prescribed it.
Ingredients
EPCLUSA contains a combination of the antiviral medications velpatasvir and sofosbuvir. They work via two different mechanisms that help to treat the infection more effectively.
Velpatasvir
HCV is made up of viral genetic material and a protein coat. When HCV makes copies of itself, it must copy both the genetic material and the protein coat. NS5B is a protein that is important for replication of the viral genetic material, and velpatasvir binds to it, shutting it down.
Sofosbuvir
Sofosbuvir inhibits a protein critical to the replication of hepatitis C, NS5B RNA-dependent RNA polymerase. This enzyme helps to replicate the virus's genetic code, and by stopping this enzyme, sofosbuvir prevents the virus from replicating itself.
Fact Table
Formula
Sofosbuvir: C22H29FN3O9P, Velpatasvir: C49H54N8O8
License
AU, EU EMA, US FDA
Bioavailability
Sofosbuvir: 92%, Velpatasvir: 25-30%
Legal status
RX Only
Chemical Name
Sofosbuvir, Velpatasvir
Elimination half-life
Sofosbuvir: 0.4 hours, Velpatasvir: 15 hours
Dosage (Strength)
400mg/100mg (28 tablets)
Pregnancy
Consult a doctor
Brands
Epclusa, Vosevi
Protein binding
Sofosbuvir: 61–65%, Velpatasvir: greater than 99.5%
PubChem CID
Sofosbuvir: 45375808, Velpatasvir: 67683363
MedlinePlus
a616034
ChEBI
Sofosbuvir: 85083, Velpatasvir: 133009
ATC code
J05AP55
DrugBank
Sofosbuvir: DB08934, Velpatasvir: DB11613
KEGG
Sofosbuvir: D10366, Velpatasvir: D10366
Routes of administration
Oral
Cautions
Tell your doctor if you have ever tested positive for the hepatitis B virus. In some people that are infected with both hepatitis C and hepatitis B, EPCLUSA may cause a dormant hepatitis B virus to re-activate. If this happens, it can cause fulminant hepatitis, liver failure, and death.
EPCLUSA has an important drug interaction with the antiarrhythmic drug amiodarone. Tell your doctor or pharmacist if you are taking this medication. People who have taken both may experience a dangerous slowing of the heart called bradycardia.
Side Effects
The most common side effects of EPCLUSA may include:
- Anemia
- Asthenia
- Chills
- Decreased appetite
- Depression
- Diarrhea
- Fatigue
- Fever
- Flu-like symptoms
- Headache
- Increased kidney enzymes
- Increased liver enzymes
- Insomnia
- Irritability
- Myalgia
- Nausea
- Neutropenia
- Pruritis
- Skin rash
Not everyone gets the same side effects of EPCLUSA. Speak with your doctor or pharmacist to learn the full list of side effects and which are most relevant to you.References
- Epclusa [package insert]. Foster City, CA: Gilead; 2016.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13250
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