CATIE News

20 July 2016 

Hepatitis C treatment Epclusa approved in Canada—key information

On July 11, 2016, Health Canada licensed the sale and use of a new fixed-dose combination of two anti-hepatitis C virus (HCV) drugs sold under the brand name Epclusa and made by the pharmaceutical company Gilead Sciences. Epclusa contains the following medicines:

  • sofosbuvir – 400 mg
  • velpatasvir – 100 mg

Clinical trials

In clinical trials, Epclusa was taken once daily with or without food for 12 consecutive weeks. In those trials it was found to be highly effective in people with chronic HCV infection. Epclusa is effective against all major strains, or genotypes, of HCV—specifically, genotypes 1 through 6. Epclusa was generally safe in clinical trials. Side effects were usually temporary and of mild to moderate intensity. Common general side effects included the following:

  • tiredness and/or lack of energy
  • headache
  • nausea

As with other treatments for HCV, side effects and complications may be more likely in patients who have symptoms of severe liver injury (decompensated cirrhosis).

Here is how Epclusa is meant to be used for different types of HCV-associated liver disease:

  • people who have chronic HCV infection without cirrhosis (severe scarring of the liver) or who have compensated (symptom-free) cirrhosis – one tablet taken once daily with or without food for 12 consecutive weeks
  • people who have chronic HCV infection and symptoms (decompensated) of cirrhosis – one tablet taken once daily with or without food for 12 consecutive weeks. The antiviral drug ribavirin must also be taken. Ribavirin is taken twice daily with food, also for 12 consecutive weeks.

Summary of important safety information

Before starting a new medication, always speak to your doctor, nurse and pharmacist about its potential interactions with other drugs (such as prescribed and over-the-counter medicines, supplements and herbs). These healthcare providers can tell you how to take Epclusa safely.

Here is some limited safety information:

  • The drug amiodarone is used to treat abnormal heart rhythm. Gilead does not recommend that people who are taking amiodarone also take Epclusa, as this can result in reduced heart rhythm (slower rate of heart beats; bradycardia). This can be dangerous. If patients taking amiodarone have no alternative to using Epclusa, Gilead recommends that doctors order cardiac monitoring in people who take these medicines together.
  • Epclusa contains velpatasvir. The HIV drug efavirenz (Sustiva, Stocrin and in Atripla) reduces the amount of velpatasvir in the blood. Therefore, efavirenz users should not take Epclusa.
  • The herb St. John’s wort (or its active ingredients hypericin and hyperforin) should not be used with Epclusa, as it can lower levels of both sofosbuvir and velpatasvir.

Access to Epclusa

After Health Canada licenses a drug, physicians can prescribe it but patients must pay for it themselves unless they have a private insurance plan that covers it. It may take weeks or months for such coverage to take effect after licensure.

If left untreated, HCV infection eventually leads to catastrophic disease that can affect one’s ability to work. HCV treatment is also expensive. Therefore, in Canada, provincial and territorial ministries of health heavily subsidize the cost of anti-HCV medications. Each ministry has a listing of drugs for which it is prepared to pay. These listings are called formularies. Formularies can also place restrictions on who can access the drugs they are covering.

In the months ahead, Gilead Sciences and provincial and territorial formularies will be negotiating the price of Epclusa. Your pharmacist, nurse or doctor can tell you when Epclusa is listed on your region’s formulary.

The wholesale cost of Epclusa in Canada is about $60,000 for a 12-week course of therapy. Pharmacies in Canada can anticipate being able to order Epclusa from wholesalers by mid-August 2016.

The pharmaceutical company has stated: “To assist eligible HCV patients in Canada with access to Epclusa, Gilead Canada has added Epclusa to the Gilead Momentum Support Program, which provides information to patients and healthcare providers to help ensure patient access to medication.” Patients who may be interested in the use of Epclusa should first speak to their healthcare provider. For more information regarding the Momentum Support Program in Canada, call 1.855.447.7977.

Further information about Epclusa clinical trials will appear in TreatmentUpdate 216, which will be released later in July 2016.  A CATIE fact sheet on Epclusa is in development. Until then, additional information about some clinical trials of Epclusa and other HCV-related issues appears below.

Resources

—Sean R. Hosein

REFERENCE:

Gilead Sciences Canada. Epclusa (sofosbuvir/velpatasvir) tablets 400 mg/100 mg antiviral agent. Product Monograph. 8 July 2016.