Epclusa

Epclusa is an oral tablet containing two drugs used for the treatment of chronic infection with the hepatitis C virus (HCV), genotype 1,2,3,4, 5, or 6 in adults without cirrhosis or with compensated cirrhosis. It also may be combined with ribavirin (Rebetol) for treatment of adults with decompensated cirrhosis.

The components belong to a class of drugs called direct-acting antiviral agents. Similar drugs include

• boceprevir (Victrelis),
• sofosbuvir (Sovaldi),
• simeprevir (Olysio),
• telaprevir (Incivek),
• Viekira Pak (ombitasvir, paritaprevir, ritonavir, dasabuvir), and
• Harvoni (ledipasvir and sofosbuvir).

Epclusa contains velpatasvir and sofosbuvir. Sofosbuvir is converted to an active form in the body before it is effective. The active form of sofosbuvir directly blocks replication of the HVC by interfering with a hepatitis C virus enzyme called NS5B. Velpatasvir is an inhibitor of another hepatitis C virus enzyme called NS5A, which also is needed for viral replication. Both drugs in Epclusa interfere with enzymes needed by hepatitis C virus to multiply and make new viruses, thus reducing the overall viral load.

Epclusa does not require administration with interferons or ribavirin (Rebetol) except when used to treat patients with decompensated cirrhosis. In some clinical studies, 98%-100% of patients were cured after 12 weeks of Epclusa treatment. Cure was defined as undetectable levels of hepatitis C virus in the blood when measured three months after the completion of treatment.

Epclusa was approved by the FDA in June, 2016.

Common side effects of Epclusa include:

• Tiredness
• Headache
• Nausea
• Diarrhea
• Insomnia
• Anemia

Other side effects of Epclusa include:

• Weakness
• Irritability
• Rash
• Depressed mood

Other less common side effects of Epclusa include:

• Increased blood levels of lipase
• Increased blood levels of creatinine kinase
• Increased blood levels of indirect bilirubin

Possible serious side effects include:

• There is an increased risk of low heart rate (bradycardia) when Epclusa is combined with amiodarone (Cordarone).

• The recommended dose of Epclusa is one tablet taken once daily with or without food.
• Patients without cirrhosis and patients with compensated cirrhosis are treated with Epclusa alone for 12 weeks.
• Patients with decompensated cirrhosis are treated with Epclusa plus ribavirin for 12 weeks.

• Acid reducing agents that are commonly used to treat heartburn, indigestion, and GERD may decrease the effectiveness of Epclusa treatment by decreasing blood levels of velpatasvir. Examples of acid reducing agents include antacids, histamine 2 receptor antagonists, for example, famotidine (Pepcid), and proton pump inhibitors (PPIs), for example, omeprazole (Prilosec).
• Antacid and Epclusa administration should be separated by 4 hours. Doses of histamine 2 receptor antagonists equivalent to famotidine 40 mg twice daily or less and doses of proton pump inhibitors equivalent to 20 mg of omeprazole or lower may be given at the same time as Epclusa.
• Co-administration of Epclusa and amiodarone is not recommended because the combination may cause serious heart-related side effects including symptomatic bradycardia (slow heart rate).
• Anti-seizure medications including carbamazepine (Tegretol), phenytoin (Dilantin), phenobarbital (Luminal), and oxcarbazepine (Trileptal) may increase the breakdown of Epclusa, leading to reduced therapeutic effectiveness.
• Taking St. John's Wort or rifampin with Epclusa may also reduce the effectiveness of treatment and is not recommended.
• Certain medication used to treat tuberculosis (TB) infection may decrease the effectiveness of Epclusa treatment. Patients taking rifampin, rifabutin, or rifapentine should consult with their doctor or pharmacist before starting Epclusa.
• Co-administration of Epclusa with rosuvastatin (Crestor) or atorvastatin (Lipitor) cholesterol lowering medications may significantly increase the blood concentration of rosuvastatin or atorvastatin and increase the risk of side effects such as serious muscle injury.
• Drug interactions between Epclusa and certain HIV antiretroviral therapies such as efavirenz (Sustiva), tenofovir (Viread), tipranavir (Aptivus), and ritonavir (Norvir) have also been reported. Patients receiving HIV treatment are advised to consult with their doctor or pharmacist before starting Epclusa.

• Although no fetal adverse events were reported in animal studies, adequate studies of Epclusa treatment in pregnant women are lacking. Therefore, Epclusa should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. However, ribavirin which may be combined with Epclusa should not be used by pregnant women or their male partners.
• It is not known whether Epclusa is excreted into human milk. Due to the lack of conclusive safety data, Epclusa should be used cautiously while breastfeeding.

What preparations of Epclusa sofosbuvir and velpatasvir are available?

Fixed dose oral tablets containing 400 mg sofosbuvir and 100 mg velpatasvir.

How should I keep Epclusa sofosbuvir and velpatasvir stored?

Epclusa should be stored below 30 C (86 F) and in its original container.