Epclusa (Sofosbuvir and Velpatasvir) – Oral

Warning:

If you have hepatitis B virus (HBV), taking Epclusa (sofosbuvir and velpatasvir) can potentially reactivate the virus. HBV can lead to serious health issues, such as liver failure, and death.

What Is Epclusa?

Epclusa (sofosbuvir and velpatasvir) is an oral antiviral combination medication used to treat viral infections like hepatitis C.

Hepatitis is a general term for what occurs when the liver is swollen or inflamed. Specifically, hepatitis C is a viral type of hepatitis caused by the hepatitis C virus (HCV). Other forms of hepatitis may be caused by heavy alcohol use or, more rarely, drugs like nonsteroidal anti-inflammatory drugs (NSAIDs).

Sofosbuvir works by preventing HCV from duplicating. It specifically inhibits a protein called NS5B polymerase, which the virus requires to duplicate itself. Sofosbuvir can inhibit NS5B effectively with relatively few side effects and a low rate of failure or resistance.

The other active ingredient, velpatasvir, works similarly. However, velpatasvir prevents another protein called NS5A from working. The combined effects of velpatasvir and sofosbuvir make Epclusa an effective treatment for HCV.

If you have hepatitis B virus while taking Epclusa, the HBV can become active again during or after treatment. You will be tested for HBV before starting this medication.

Eplcusa is administered orally via tablets or pellets.

Drug Facts

Generic Name: Sofosbuvir and velpatasvir

Brand Name(s): Epclusa

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: Antiviral

Available Generically: Yes

Controlled Substance: N/A

Active Ingredient: Sofosbuvir and velpatasvir

Dosage Form(s): Tablet, pellets (packet)

What Is Epclusa Used For?

The Food and Drug Administration (FDA) approved Epclusa for the treatment of chronic (long-lasting) HCV infection of genotypes 1–6, as follows:

  • Without liver scarring or with liver scarring without symptoms
  • With liver scarring with symptoms for use in combination with ribavirin

It is not indicated to treat HCV infection of genotype 7.

HCV can cause both acute (short-term) and chronic hepatitis. Chronic HCV lasts six months or longer and carries the risk of serious illnesses, such as liver cirrhosis and cancer, if left untreated. If diagnosed early, prompt treatment can help prevent serious health problems down the road.

How to Take Epclusa

Always follow directions from your prescribing healthcare provider on how to take your medication. Generally, Epclusa is taken once a day with or without food. It must be taken four hours before or after taking antacids or eating dairy products like yogurts that contain certain kinds of metal ions. Common metal ions are calcium, magnesium, and aluminum.

Additionally, you should take your Epclusa dose at least 12 hours apart from stomach acid-reducing drugs, such as Pepcid AC (famotidine) or Protonix (pantoprazole). Taking these medications too close together may decrease Epclusa absorption, reducing how well it works in your body.

The oral pellets can be taken with food or administered directly in the mouth and swallowed whole. Children under 6 who are prescribed oral pellets should take it with nonacidic soft food, such as pudding, chocolate syrup, or ice cream.

Storage

Store Epclusa in a cool, dry place. In general, medications should not be stored in hot or humid spaces, such as your kitchen or bathroom. These environments can affect how well medications work. It is also important to keep this medication away from children and pets to prevent accidental consumption.

Refilling and traveling with this medication carries no special instructions. Since it is an expensive medication, not all pharmacies have it. If you need more medication, speak to your pharmacy or healthcare provider's office to request a refill before traveling. Similarly, the Transportation Security Administration (TSA) has no restrictions on traveling by plane.

Off-Label Uses

Epclusa has generally only been researched for the use of HCV. The components have been studied in other diseases, either alone or together. For example, sofosbuvir has been studied in the following disorders:

  • COVID-19 with another antiviral daclatasvir
  • HBV when used in combination with another antiviral ledipasvir

COVID-19

Sofosbuvir has been studied for use with another antiviral called daclatasvir for COVID-19. Sofosbuvir alone is approved to treat HCV. HCV and SARS-CoV-2, the virus that causes COVID-19, are both positive sense RNA, single-stranded viruses that can be directly converted into a protein.

Daclatasvir inhibits the protein NS5A to block viral replication, which stops it from spreading in the body. A systematic review and meta-analysis (an analysis of all evidence on a single topic combined with a statistical summary of systematic review results) suggested that this combination may improve recovery odds in people with COVID-19, although no survival benefit was determined.

Despite these findings, due to a lack of data, the combination is not currently recommended in the United States for COVID-19. 

Hepatitis B

Sofosbuvir was also studied with another antiviral, ledipasvir, to treat HBV. HCV and HBV are similar, with the main difference being that HBV has a different type of DNA.

The DNA of HBV allows the virus to move more easily into an infected person’s cells and replicate. Ledipasvir works similarly to velpatasvir and daclatasvir in inhibiting NS5A to block viral replication. However, no definitive conclusions about sofosbuvir and ledipasvir's efficacy in treating HBV have been made from the research.

How Long Does Epclusa Take to Work?

Epclusa usually works within a couple of hours, and your treatment may last between 12 to 24 weeks depending on your condition. If you do not feel better at this time, it is important to contact your healthcare provider.

What Are the Side Effects of Epclusa?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

The most common side effects of Epclusa are listed below:

  • Headache
  • Fatigue
  • Nausea
  • Trouble sleeping

In children under 6 years, the most common side effects are vomiting and spitting up the medication.

Severe Side Effects

Call your healthcare provider immediately if you have serious side effects. Call 911 if you have life-threatening symptoms or think you’re having a medical emergency.

Severe side effects associated with Epclusa include allergic reactions and liver failure.

Signs of an allergic reaction may include:

  • Sudden itchiness or hives
  • Difficulty breathing or swallowing
  • Swelling of the face or throat

Indications of liver damage may include:

  • Severely discolored urine
  • Yellowing of the skin or the white areas of the eyes (jaundice)
  • Sudden vomiting
  • Abnormal colored stools

Long-Term Side Effects

Epclusa is a relatively well-tolerated medication, and long-term side effects are limited. However, if you have liver scarring, you may sometimes still experience symptoms of damage to your liver, even after you no longer have HCV. You should contact your healthcare provider if you are experiencing this, as they will want to monitor you more closely.

Report Side Effects

Epclusa may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Epclusa Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For hepatitis C virus infection:
      • Adults—One tablet once a day, taken for 12 weeks. Each tablet contains sofosbuvir 400 milligrams (mg) and velpatasvir 100 mg.
      • Children 3 years of age and older or weighing at least 30 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
        • Weighing at least 30 kilograms (kg)—One tablet (containing 400 mg sofosbuvir and 100 mg velpatasvir) once a day or two tablets (containing 200 mg sofosbuvir and 50 mg velpatasvir) taken for 12 weeks.
        • Weighing 17 to less than 30 kg—One tablet (containing 200 mg sofosbuvir and 50 mg velpatasvir) once a day taken for 12 weeks.
      • Children 3 years of age and older weighing less than 17 kg—Use of oral pellets is recommended.
      • Children younger than 3 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (pellets):
    • For hepatitis C virus infection:
      • Children 3 years of age and older or weighing at least 30 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
        • Weighing at least 30 kilograms (kg)—Two packets (containing 200 mg sofosbuvir and 50 mg velpatasvir, total of 400 mg sofosbuvir and 100 mg velpatasvir) once a day taken for 12 weeks.
        • Weighing 17 to less than 30 kg—One packet (containing 200 mg sofosbuvir and 50 mg velpatasvir) once a day taken for 12 weeks.
        • Weighing less than 17 kg—One packet (containing 150 mg sofosbuvir and 37.5 mg velpatasvir) once a day taken for 12 weeks.
      • Children younger than 3 years of age—Use and dose must be determined by your doctor.

Modifications

Due to the possible effects of this medication, there may be changes to how it is used. Therefore, users need to be aware of the following when taking Epclusa.

In children age 3 and older, the dose may be based on weight and therefore be lower than the usual dose. The dosage form may change from tablets to oral pellets in this case. Oral pellets allow more for more specific dosages while also being easier for children to take.

Missed Dose

If you miss a dose of Epclusa, take the next dose as soon as you remember. If it is close to the time for your next dose, skip the missed dose and return to your normal schedule. You should not take more than one dose on the same day unless otherwise directed.

Missing doses may require you to be on therapy longer as it may take more time for your HCV to clear up.

Overdose: What Happens If I Take Too Much Epclusa?

There is no set dose that indicates you have taken too much Epclusa. Generally, you should not take more than prescribed to you. If you do overdose, you may need to undergo hemodialysis to remove part of the drug from your bloodstream.

Signs of an Epclusa overdose may include:

  • Confusion
  • Forgetfulness
  • Sudden change in smell
  • Slurred speech, which can indicate brain inflammation caused by a buildup of toxins due to a failing liver

If you or someone else experiences these symptoms, contact a Poison Control Center or 911 immediately. Symptoms must be treated as soon as possible to prevent complications.

Report Side Effects

Epclusa may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not take this medicine together with other products containing sofosbuvir (eg, Sovaldi®).

Ribavirin may cause birth defects if either partner is using it together with this medicine during conception or pregnancy. Females who take this medicine with ribavirin should avoid becoming pregnant during treatment and for at least 6 months after the last dose. Tell your doctor right away if you or your partner becomes pregnant. Follow all directions about birth control.

If you have ever had a hepatitis B infection or if you have been coinfected with a hepatitis B or C virus and have or have not received treatment, the virus could become active again during treatment with sofosbuvir and velpatasvir combination. You should be tested for hepatitis B infection before starting treatment with this medicine. Talk with your doctor if you have concerns.

Amiodarone can cause serious side effects (eg, cardiac arrest, slow heartbeat, conditions that need pacemaker) if used together with medicines containing sofosbuvir (including ledipasvir and sofosbuvir combination, Harvoni®), or if you have used it recently. This is more likely to occur in patients with heart disease or advanced liver disease. Tell your doctor if you are taking amiodarone before using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What Are Reasons I Shouldn’t Take Epclusa?

You should not take this medication if you are allergic to any of its ingredients.

Epclusa use should be heavily monitored in people with diabetes or HBV. If you have diabetes, the risk for excessively low blood sugar increases, so you need to watch your blood sugar closely. You will need to be tested for HBV before starting therapy. If you have HBV and take Epclusa, the virus can become reactivated and worsen.

What Other Medications Interact With Epclusa?

You may need extra monitoring if you take the following medications with Epclusa:

  • Amiodarone (such as Pacerone or Cordarone): This combination can cause a slow heartbeat, which may occur two weeks after taking HCV treatment. You will need to be monitored in the hospital for at least 48 hours after starting amiodarone, with further outpatient or self-monitoring of heart rate for at least two weeks.
  • Warfarin (such as Coumadin or Jantoven): Your healthcare provider will monitor your internalized normalized ratio (INR) tests routinely, as Epclusa can decrease INR, which increases your risk of blood clots.

Epclusa also interacts with drugs known as cytochrome P450 (CYP450) inhibitors. Once Epclusa is absorbed in the body, it undergoes chemical changes by the CYP450 proteins. CYP450 inhibitors are drugs that decrease how much the CYP450 proteins work. These medications can increase how much Epclusa is in the body and thereby increase Epclusa's effects.

Examples of CYP450 inhibitors include:

Conversely, some drugs (known as “inducers”) can also increase the work of these proteins. Inducers can decrease how much Epclusa is in the body and, as a result, reduce the effects of the medication. Some examples of CYP450 inducers include:

This may not be a complete list of drug interactions that can occur with Epclusa. Tell your pharmacist or healthcare provider before starting any new medications, including over-the-counter (OTC) and prescription drugs, and vitamins and herbal supplements, to ensure they are safe to take.

What Medications Are Similar?

Epclusa is in the antiviral drug class used to treat HCV. Ribavirin is sometimes given with Epclusa.

Other examples of antivirals used for HCV are below:

  • Zepatier (elbasvir and grazoprevir)
  • Harvoni (ledipasvir and sofosbuvir)

This is a list of drugs also prescribed for HCV. It is not necessarily a list of drugs recommended to take with Epclusa. Some of these drugs should not be taken together. For example, the combination of ledipasvir and sofosbuvir and Epclusa should not be given together; they both contain sofosbuvir and can increase the chance of an overdose and unwanted side effects.

Frequently Asked Questions

  • Can I travel with Epclusa?

    There are no restrictions for traveling on a plane with Epclusa. Epclusa is in a solid dosage form, and will generally be fine to bring in a carry-on bag. Since it is a special and expensive medication, it is recommended to get your refills and have enough supply before traveling.

  • How can I manage the side effects of Epclusa?

    Try taking Epclusa with food if you start to experience gastrointestinal-related side effects, such as nausea or stomach upset. A healthy diet that consists of ample amounts of fiber can also help reduce stomach-related adverse effects.

  • How much does Epclusa cost? Is there a way I can get help paying for it?

    Eplcusa, and HCV treatment in general, can be expensive. Costs for individual medications can vary depending on different factors, such as which pharmacy you use and whether your health insurance plan covers the medication.

    However, there are patient assistance programs offered by the manufacturer, which may help. There is also an authorized generic available, which is typically a cheaper alternative.

    If you have trouble affording your treatment, talk to your healthcare team about other financial assistance options, such as nonprofit programs, that may be available.

How Can I Stay Healthy While Taking Epclusa?

To stay healthy while taking Epclusa, it is important to adhere to your medication regimen as directed by a healthcare provider or pharmacist. It may be difficult to remember initially, but regular use is necessary to cure your HCV and prevent long-term complications.

Additionally, while undergoing treatment, remember to get plenty of rest, stay hydrated, and eat a healthy, well-balanced diet. Also, follow your healthcare provider's instructions on what medications you may need to avoid while taking Epclusa, especially those that could harm your liver.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

12 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. DailyMed. Label: Epclusa Access- velpatasvir and sofosbuvir tablet, film coated.

  2. Centers for Disease Control and Prevention. What is viral hepatitis?

  3. Johns Hopkins Medicine. Drug-induced hepatitis.

  4. Bhatia HK, Singh H, Grewal N, Natt NK. Sofosbuvir: a novel treatment option for chronic hepatitis C infection. J Pharmacol Pharmacother. 2014;5(4):278-284. doi:10.4103/0976-500X.142464.

  5. Bonaventura A, Montecucco F. Sofosbuvir/velpatasvir: A promising combination. World J Hepatol. 2016;8(19):785-789. doi:10.4254/wjh.v8.i19.785.

  6. Ghany MG, Morgan TR; AASLD-IDSA Hepatitis C Guidance Panel. Hepatitis C guidance 2019 update: American Association for the Study of Liver Diseases-Infectious Diseases Society of America recommendations for testing, managing, and treating hepatitis C virus infection. Hepatology. 2020;71(2):686-721. doi:10.1002/hep.31060.

  7. World Health Organization. Hepatitis C.

  8. Chen CK, Weng TS, Chen YH, et al. Clinical efficacy of sofosbuvir/daclatasvir in patients with COVID-19: a systematic review and meta-analysis of randomized trials. Expert Rev Clin Pharmacol. 2022. doi: 10.1080/17512433.2022.2103539

  9. Liu CJ, Chuang WL, Sheen IS, et al. Efficacy of ledipasvir and sofosbuvir treatment of HCV infection in patients coinfected with HBV. Gastroenterology. 2018;154(4):989-997. doi:10.1053/j.gastro.2017.11.011

  10. Food and Drug Administration. Sovaldi label.

  11. ClinicalTrials.gov. Ledipasvir/sofosbuvir for hepatitis B virus infection (APOSTLE).

  12. Lynch T, Price A. The effect of cytochrome P450 metabolism on drug response, interactions, and adverse effects. Am Fam Physician. 2007;76(3):391-396. PMID:17708140.