Epclusa (sofosbuvir, velpatasvir)

Epclusa (sofosbuvir and velpatasvir) is a combination medication used to treat chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infection in adults, as well as pediatric patients age 6 years and older.1 Specifically, Epclusa is indicated for treatment of these genotypes without cirrhosis or with compensated cirrhosis. More recently, Epclusa was also approved for the treatment of children with all genotypes of hepatitis C with no or mild cirrhosis. For adults and children with decompensated cirrhosis, Epclusa can be used with ribavirin.

What are the ingredients in Epclusa?

The active ingredients in Epclusa are sofosbuvir and velpatasvir.

How does Epclusa work?

Epclusa is a combination of two direct-acting antivirals, with one active ingredient, sofosbuvir, inhibiting the HCV NS5B RNA-dependent RNA polymerase. Essentially, this inhibitor affects the virus’ ability to replicate, thus, stopping its reproduction. The other active ingredient, velpatasvir acts as an inhibitor of HCV NS5A. NS5A is a nonstructural protein made by the HCV virus that is important to the virus’ growth and replication. The exact mechanism by which NS5A works is unknown. The inhibitor works to eliminate these crucial proteins made by the virus utilized for RNA replication and virion assembly. In theory, by inhibiting these proteins the virus will be prevented from further growth and reproduction. Many direct-acting antivirals work in this manner, targeting proteins and specific steps in the HCV life cycle.

What are the possible side effects?

Multiple clinical trials evaluated the safety and efficacy of Epclusa. The most common side effects of Epclusa are headache and tiredness. When taken with ribavirin, the most common side effects are:

  • Headache
  • Tiredness
  • Anemia (low red blood cell count)
  • Nausea
  • Insomnia
  • Diarrhea

These are not all the possible side effects of Epclusa. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Epclusa.

Things to note

There is a possibility of HBV reactivation while taking Epclusa if you have a history of HBV. Your provider will administer a blood test before starting Epclusa to monitor your risk of HBV reactivation. Reactivation of HBV could cause serious liver problems including liver failure or death. It is important to also consult the prescribing information for any medications you are also taking in combination with Epclusa, including ribavirin.2

When taking Epclusa there is a chance of developing bradycardia, or abnormally slow heart rate. This risk is especially prevalent in those taking amiodarone, a medicine used to treat heart conditions. Seek immediate help if you experience any of the following related to bradycardia:

  • Weakness
  • Near-fainting or fainting
  • Chest pain
  • Dizziness
  • Confusion
  • Shortness of breath
  • Memory problems
  • Tiredness

Before staring Epclusa talk to your provider if you:

  • Have or have had hepatitis B infection
  • Have or have had liver problems other than those related to HCV
  • Have severe kidney problems or are on dialysis
  • Have any other medical conditions
  • Are taking any other medications, supplements, or vitamins
  • Are pregnant or are planning to become pregnant. It is not known if Epclusa will affect an unborn baby.
  • Are breastfeeding or planning to breastfeed. It is not known if Epclusa can pass through breast milk.

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Written by: Casey Hribar | Last reviewed: March 2021