Generic Name: sofosbuvir/velpatasvir

Pronunciation: N/A

Abbreviation: SOF/VEL

Other Market Name: N/A

Drug Class: Multi-Class Combination Drugs

Company: Gilead Sciences

Approval Status: Approved

Generic Version Available: Yes

Experimental Code: GS-7977 + GS-5816


Drug Indication

FDA-approved for the treatment of chronic hepatitis C genotypes 1 through 6 infection in adults, with or without cirrhosis, including decompensated cirrhosis.


General Info

  • Epclusa contains a nucleotide analog NS5B polymerase inhibitor (sofosbuvir) and an NS5A inhibitor (velpatasvir).
  • Epclusa was approved by the U.S. Food and Drug Administration on June 28, 2016 for the treatment of chronic hepatitis C infection in adults for genotypes 1 through 6.
  • In clinical studies, approximately 98 percent of participants without decompensated cirrhosis were cured with 12 weeks of treatment; 94 percent of those with decompensated cirrhosis who took Epclusa with ribavirin were cured with 12 weeks of treatment. 
  • Epclusa has a high barrier to drug resistance. 
  • In 2019, Gilead authorized it’s subsidiary, Asegua Therapeutics to sell a generic version of Epclusa (sofosbuvir/velpatasvir).


Dosage

Adult Dose: Epclusa combines two drugs into a single tablet taken orally once daily with or without food. If ribavirin is prescribed, follow additional dosing instructions for that drug.

Pediatric Dose: N/A

Dosing Info: Treatment is for 12 weeks. The addition of ribavirin is recommended for those with decompensated cirrhosis.


Side Effects

  • Side effects associated with Epclusa are considered mild. The most common are fatigue and headache.
  • Taking Epclusa with ribavirin increases the type, frequency and intensity of side effects. When Epclusa was used with ribavirin in decompensated cirrhotics, the most common adverse events were fatigue, anemia, nausea, headache, insomnia and diarrhea.


Drug Interactions

  • Before taking this medication, tell your medical provider and pharmacist about any drugs, supplements and herbs you take, whether prescribed, over-the-counter or illicit.
  • Other drugs that may interact with Epclusa are topotecan (a chemotherapy agent), amiodarone, antacids and other acid-reducing drugs, certain anti-seizure medications and some HIV and TB drugs.
  • Epclusa may interact with drugs and herbs that are metabolized in the liver and intestines, such as St. John’s wort and rifampin. Additional drug-drug interactions may occur, and these are listed in Epclusa’s full prescribing information. Potential interactions are listed at hep-druginteractions.org.


Other Info

  • Warning: Patients who are coinfected with hepatitis B and C who take this medication may be at risk of hepatitis B virus (HBV) reactivation. Before taking this medication, be sure your doctor has tested you for evidence of current or prior hepatitis B virus infection.  HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in serious hepatitis flares, liver failure, and death. 
  • Pregnant women or those who are trying to become pregnant should not take Epclusa if it is prescribed with ribavirin. Women of childbearing age and their male sexual partners must use two forms of birth control throughout treatment and for six months after treatment if ribavirin is prescribed.
  • There are no adequate, well-controlled studies in pregnant women who have taken Epclusa without ribavirin. Epclusa should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • The safety of breast feeding while taking Epclusa has not been established.


For More Info: http://www.mysupportpath.com

Co-Pay Program Info: http://www.hepmag.com/basics/hepatitis-c-basics/paying-hepatitis-c-treatment

Patient Assistance Program Info: http://www.hepmag.com/basics/hepatitis-c-basics/paying-hepatitis-c-treatment

Last Reviewed: March 7, 2019