What is Epclusa Uses, warnings & interactions
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Epclusa (sofosbuvir/velpatasvir) is a combination antiviral medication that is manufactured by Gilead Sciences, Inc. It is used to treat chronic hepatitis C, which is a viral infection that affects the liver. Epclusa can be used in adults and children 3 years of age and older.
What is Epclusa used for?
Epclusa is a fixed-dose combination medication that contains a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor (sofosbuvir) and an HCV NS5A inhibitor (velpatasvir). It is approved by the U.S. Food and Drug Administration (FDA) to treat adults and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infections.
Epclusa can be used alone in patients without cirrhosis or if they have compensated cirrhosis (Child-Pugh A). It should be taken along with Rebetol (ribavirin) in patients with decompensated cirrhosis (Child-Pugh B or C).
How does Epclusa work?
Hepatitis C is a viral infection of the liver that is passed through blood and body fluids. Untreated hepatitis C can lead to cirrhosis, liver cancer, or liver failure.
Epclusa uses 2 different mechanisms of action to help treat acute and chronic hepatitis C infections. Sofosbuvir is a prodrug that once activated prevents HCV replication by blocking HCV NS5B RNA polymerase activity. Velpatasvir blocks the NS5A protein that is required for viral replication.
Epclusa is very effective, with an overall cure rate of 98% in studies of genotype 1-6 patients without cirrhosis or with compensated cirrhosis (liver disease that usually doesn’t cause symptoms). To be “cured” meant there was no HCV detected in the blood 3 months after completing treatment.
What are the most commonly prescribed doses of Epclusa?
- 400mg/100mg tablets
- 200mg/50mg tablets
- 200mg/50mg oral pellets
- 150mg/37.5mg oral pellets
Before taking Epclusa
Before starting Epclusa, tell your healthcare provider if you have any of the following medical conditions:
- Hepatitis B virus
- Liver problems other than HCV
- Have had a liver transplant
- Are on dialysis
- Diabetes
- HIV
- Are pregnant, plan on becoming pregnant, or are breastfeeding
How to take Epclusa
- Read the Full Prescribing Information, Instructions for Use, and Medication Guide that comes with Epclusa.
- Use Epclusa exactly as your doctor prescribes it. Do not change your dose or stop taking this medication without discussing it with them first.
- Epclusa is typically taken once a day with or without food.
- Epclusa oral pellets should be swallowed whole with or without food. For pediatric patients younger than 6 years, Epclusa oral pellets should be taken with food. Do not chew the oral pellets. You should only open the Epclusa oral pellets packet when ready to use.
- Epclusa tablets or oral pellets should be stored in the original container below 86°F (30°C). Discard Epclusa oral pellets if the carton tamper-evident seal or the packet has been damaged or opened.
Epclusa contraindications
Epclusa is contraindicated in patients who have any of the following:
- Hypersensitivity reaction to Epclusa or any of its inactive ingredients.
Epclusa warnings
- Epclusa use is associated with hepatitis B virus (HBV) reactivation in coinfected patients. All patients should be tested for current or prior HBV infection before starting Epclusa treatment.
- Epclusa use with Pacerone (amiodarone) is not recommended as slow heart rate (bradycardia) may occur.
Common side effects of Epclusa
The most common side effects of Epclusa include:
- Headache
- Extreme tiredness
- Anemia
- Nausea
- Vomiting
- Insomnia
- Diarrhea
- Rash
- Increased liver enzymes
Epclusa can cause serious side effects including:
- Hepatitis B reactivation
- Slow heart rate, chest pain, or shortness of breath when taken with Pacerone (amiodarone)
Contact your healthcare provider for medical advice about any side effects you experience while taking Epclusa. You can report your side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Epclusa drug interactions
When Epclusa is taken with other medicines, they may interact and change how they work. They can also change the frequency and severity of certain side effects. Make sure your healthcare provider is aware of all prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take. Some major drug interactions with Epclusa include:
- Anticonvulsant medications such as Tegretol (carbamazepine), Dilantin (phenytoin), and Luminal (phenobarbital)
- HIV medications such as Sustiva (efavirenz), Aptivus (tipranavir), Viread (tenofovir), and Norvir (ritonavir)
- Medications that increase gastric pH such as antacids, Pepcid (famotidine), and Prilosec (omeprazole)
- Antibiotics such as Mycobutin (rifabutin) and Rifadin (rifampin)
- Statins such as Crestor (rosuvastatin) and Lipitor (atorvastatin)
- St. John’s wort
- Pacerone (amiodarone)
- Lanoxin (digoxin)
- Grapefruit juice
Epclusa alternatives
There are other medications that your healthcare professional can prescribe if Epclusa is not the right medication for you. Some alternative FDA-approved treatment options include:
How does Epclusa compare with Harvoni (ledipasvir/sofosbuvir)?
Epclusa and Harvoni are both combination antiviral medications used for hepatitis c treatment in adults and children 3 years of age and older.
Epclusa contains velpatasvir and sofosbuvir while Harvoni contains sofosbuvir and ledipasvir. Epclusa is indicated to treat all 6 genotypes of HCV while Harvoni treats genotypes 1, 4, 5, and 6. They have similar side effects and drug interactions. When Epclusa and Harvoni were compared in clinical studies, both medications were effective in treating HCV. However, Epclusa had a higher cure rate in these studies than Harvoni.
There is currently no generic alternative available for either medication. Epclusa is expensive and has an average cost of over $10,000 for #28, 400mg/100mg tablets while Harvoni costs approximately $15,000 for #28, 90mg/400mg tablets.
Epclusa FAQs
Can Epclusa cure hepatitis C?
In clinical studies, Epclusa was shown to have an overall cure rate of 98% in HCV patients with genotype 1-6 without cirrhosis or with compensated cirrhosis. To be considered cured of HCV meant there was no virus detected in the blood 3 months after completing treatment.
How long does Epclusa stay in your system?
The two active ingredients in Epclusa have a half-life of 15 to 25 hours, so they will stay in your bloodstream for up to over 5 days after your last dose.
How do I store Epclusa?
You should store Epclusa tablets or oral pellets in the original container below 86°F (30°C). Do not use Epclusa oral pellets if the carton tamper-evident seal or the packet has been damaged or opened.
How long does it take for Epclusa to start working?
In clinical trials involving Epclusa, 95% to 99% of patients without cirrhosis or with mild cirrhosis had no virus detected in their blood 12 weeks after finishing the 12-week drug regimen. In patients with moderate to severe cirrhosis, some of which required Rebetol (ribavirin), 94% had no detectable virus 12 weeks after finishing treatment.
Can you take Epclusa while you are pregnant or breastfeeding?
There is insufficient data on whether the use of Epclusa during pregnancy causes any harm to your unborn baby. It is contraindicated if it is administered with Rebetol (ribavirin) in pregnant women and in men whose female partners are pregnant.
There is no data on whether Epclusa is found in breast milk or the effects it may have on the infant or milk production. You should always discuss the risks and benefits of any medication with your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding.
Is there a generic for Epclusa?
Currently, there is no generic for Epclusa available on the market. However, you can still save on brand-name drugs like Epclusa through NiceRx if eligible.