Drug Database: Sofosbuvir/Velpatasvir

What is Epclusa?What is Epclusa?

What is Epclusa?

Epclusa is an antiviral prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus infection (HCV) in adults and children 3 years of age and older who meet specific requirements, as determined by a health care provider.

HCV can be an opportunistic infection (OI) of HIV. An OI is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as people with HIV—than in people with healthy immune systems. To learn more about OIs, read the HIVinfo What is an Opportunistic Infection? fact sheet.

To learn how HIV and HCV are connected, read the HIVinfo HIV and Hepatitis C fact sheet. The fact sheet includes information about how HCV is spread, symptoms of HCV, and treatment options.

How is Epclusa used in people with HIV?How is Epclusa used in people with HIV?

How is Epclusa used in people with HIV?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV and the AASLD-IDSA HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C include recommendations on the use of Epclusa to treat acute and chronic HCV in people with HIV.

The recommended uses may not always be consistent with FDA-approved uses of Epclusa. See the Adult Opportunistic Infection Guidelines and the AASLD-IDSA HCV Guidelines for complete information on recommended uses of Epclusa in adults and children with HIV. Epclusa may have other recommended uses not listed above.

What should I tell my health care provider before taking Epclusa?What should I tell my health care provider before taking Epclusa?

What should I tell my health care provider before taking Epclusa?

Before taking Epclusa, tell your health care provider:

• If you are allergic to any of the medicines in Epclusa (sofosbuvir or velpatasvir) or any other medicines.
• About any medical conditions you have or have had, especially: 
  • Liver problems, including hepatitis B virus infection (HBV) and liver transplant
  • Kidney problems, including if you are on dialysis
• About anything that could affect your ability to take medicines, such as difficulty swallowing or remembering to take pills.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking Epclusa during pregnancy. Pregnancy should be avoided during combination treatment with ribavirin and for 6 months after completion of the treatment. The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV may include other recommendations on the use of Epclusa during pregnancy. Please refer to these guidelines for additional information. 
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John's wort) you are taking or plan to take. Epclusa may affect the way other medicines or products work, and other medicines or products may affect how Epclusa works. Ask your health care provider if there are interactions between Epclusa and the other medicines you take.

Ask your health care provider about possible side effects from Epclusa. Your health care provider will tell you what to do if you have side effects.

How should I take Epclusa?How should I take Epclusa?

How should I take Epclusa?

Take Epclusa according to your health care provider’s instructions. Your health care provider will tell you how much Epclusa to take and when to take it. Before you start Epclusa and each time you get a refill, read any printed information that comes with your medicine.

How should Epclusa be stored?How should Epclusa be stored?

How should Epclusa be stored?

• Store Epclusa tablets and pellets below 86°F (30°C).
• Keep Epclusa in the container that it came in and keep the container tightly closed.
• Do not use Epclusa if the original seal over the container opening is broken or missing.
• Throw away Epclusa that is no longer needed or expired (out of date).
• Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep Epclusa and all medicines out of reach of children.

Where can I find more information about Epclusa?Where can I find more information about Epclusa?

Where can I find more information about Epclusa?

• Recommendations on the HIV-related uses of Epclusa, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.
• Recommendations on the HIV-related uses of Epclusa, from the HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C.
• This Patient Version drug summary is based on the following FDA label(s): Tablet (film coated), pellet. The Patient Package Insert and Instructions For Use include information for people taking Epclusa.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for sofosbuvir and velpatasvir available from MedlinePlus.
• Epclusa-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)