Epclusa: 7 things you should know
Medically reviewed by Carmen Fookes, BPharm. Last updated on Oct 30, 2020.
1. How it works
- Epclusa is a fixed-dose combination medication containing velpatasvir and sofosbuvir that may be used to treat hepatitis C infection (HCV). Velpatasvir is a nucleotide analog polymerase inhibitor and sofosbuvir is a pan-genotypic NS5A inhibitor.
- Velpatasvir works by interfering with a protein, called HCV NS5A that is needed by the virus to replicate itself.
- Sofosbuvir is a prodrug that is converted to its pharmacologically active form (GS-461203), which inhibits an RNA-dependent polymerase called HCV NS5B, which is also needed by the virus to replicate itself. The ingredients in Epclusa initially greatly reduce and then completely stop the production of new copies of the hepatitis C virus.
- Epclusa belongs to the class of medicines known as hepatitis C antivirals. It may also be called a combination antiviral agent.
- Epclusa is approved for use in adults and pediatric patients at least 6 years of age or weighing at least 17 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection.
- May be used with ribavirin in patients with advanced liver disease (decompensated cirrhosis).
- Epclusa is also approved to treat chronic HCV in patients co-infected with HIV.
- Epclusa is taken orally by mouth, once a day. It comes in two strengths: 400 mg/100 mg and 200 mg/50 mg.
- May be taken with or without food.
- Epclusa has a 98% overall cure rate.
- Side effects with Epclusa are generally mild because it works directly on the HCV virus.
- No dosage adjustment is necessary for people with kidney disease. No dosage adjustment of Epclusa is recommended for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C).
- A generic version of Epclusa is available under the name of velpatasvir and sofosbuvir oral tablets (manufactured by Asegua Therapeutics LLC).
If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:
- Headache and tiredness are the most common side effects of Epclusa. Other side effects reported in more than 10% of people include anemia, diarrhea, insomnia, itching, asthenia (lack of energy), and nausea. Skin reactions may also occur.
- Reactivation of the hepatitis B virus has been reported in people who have a current or prior hepatitis B virus (HBV) infection before initiating treatment with Epclusa. In some cases, this has resulted in severe and rapid liver disease, hepatic failure, and death.
- The cost of Epclusa is roughly $78,078 for a 12-week course of treatment. Your cost might vary based on insurance or manufacturer-provided discounts.
- Epclusa may lower blood sugar levels and affect INR levels or drug concentrations of medications with a narrow therapeutic index. Monitor.
- It is not known how Epclusa affects a developing fetus. Women should refrain from becoming pregnant while taking Epclusa. Pregnancy should always be avoided in those taking ribavirin and Epclusa.
Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects
- Alcohol may increase the risk of side effects with Epclusa, such as nausea, diarrhea, fatigue, and headache. Alcohol itself can also cause liver inflammation and liver scarring (cirrhosis). Drinking alcohol while taking Epclusa may increase the risk of cirrhosis and liver failure. However, one drink now and then is unlikely to affect the outcome of treatment.
- Before you start taking Epclusa your doctor will test you for hepatitis B virus (HBV) infection. This because treating HCV may reactivate an underlying hepatitis B infection (HBV). Any underlying HBV infection should be treated before Epclusa is started.
- Epclusa is best taken at the same time every day. Follow your physician's advice with regards to the dosage of Epclusa and do not miss or skip doses. Take Epclusa for the duration that is recommended by your physician.
- Tell your doctor if you take any other medications or supplements, including those purchased from a supermarket or health store. Some medications, such as amiodarone, should not be taken with Epclusa.
- Seek urgent medical attention if you develop a very slow heartbeat, feel faint or unwell, or experience symptoms such as dizziness or lightheadedness, weakness, excessive tiredness, shortness of breath, chest pains, confusion, or memory problems.
- There is limited data as to the effects of Epclusa on a developing fetus. If you are taking Epclusa with ribavirin, you should use adequate contraception to ensure you do not become pregnant. If you do become pregnant while taking Epclusa, see your doctor immediately. The effects of Epclusa on a breastfeeding infant are also not known.
- While you are taking Epclusa to treat hepatitis C, you should take steps to ensure you do not pass HCV to others. This includes not sharing needles and practicing safe sex.
6. Response and Effectiveness
- Epclusa has a 98% overall cure rate in patients with genotype 1-6 without cirrhosis (a serious liver disease) or with compensated cirrhosis (meaning you have cirrhosis, but with mild or no symptoms). "Cure” means the Hep C virus is not detected in the blood when measured three months after treatment is completed.
- In clinical studies, 95% to 99% of Epclusa-treated patients without cirrhosis or with mild cirrhosis had no virus detected in the blood 12 weeks after finishing a 12-week regimen.
- In patients with moderate to severe cirrhosis, some of whom also required ribavirin treatment, 94% were cleared of the virus 12 weeks after finishing treatment.
Medicines that interact with Epclusa may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Epclusa. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.
Common medications that may interact with Epclusa include:
- acid-reducing agents, such as antacids (eg, aluminum and magnesium hydroxide), H2 receptor antagonists (eg, famotidine), and proton pump inhibitors (such as omeprazole)
- amiodarone (not recommended because symptomatic bradycardia, fatal cardiac arrest, and pacemaker intervention have occurred)
- anticonvulsants, such as carbamazepine, phenytoin or phenobarbital
- antimicrobials, such as rifabutin or rifampin
- HIV medications, such as efavirenz, tenofovir, tipranavir, or ritonovir
- HMG-CoA reductase inhibitors such as atorvastatin, simvastatin, or rosuvastatin
- inducers of P-glycoprotein such as carbamazepine, dexamethasone, doxorubicin, nefazodone, phenobarbital, phenytoin, prazosin, rifampicin, St. John's wort, tenofovir, tipranavir, trazodone, and vinblastine
- drugs that are substrates of breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, and OATP2B1, such as benzylpenicillin, hormones, and statins
- other HCV products such as simeprevir
- St. John's Wort
Epclusa is often given in combination with ribavirin. All the medications that interact with ribavirin will also interact with this combination. In addition, women taking ribavirin should not become pregnant while taking ribavirin.
Epclusa has been associated with changes in blood glucose control in people with diabetes resulting in serious symptomatic hypoglycemia (low blood sugar levels). The dosage of some diabetes medications may need to be reduced.
Frequent monitoring of certain relevant laboratory parameters may be necessary, such as the International Normalized Ratio (INR) in people taking warfarin, blood glucose levels in those with diabetes, or drug concentrations of concomitant medications with a narrow therapeutic index, such as immunosuppressants. Dosage adjustments of other medications may be necessary.
Note that this list is not all-inclusive and includes only common medications that may interact with Epclusa. Refer to the prescribing information for Epclusa for a complete list of interactions.
- Epclusa (velpatasvir and sofosbuvir) Updated 07/2020 Gilead Sciences, Inc. https://www.drugs.com/pro/epclusa.html
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Epclusa only for the indication prescribed.
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More about Epclusa (sofosbuvir / velpatasvir)
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