On June 28, 2016, FDA approved Gilead’s new drug, Epclusa, to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus. Knowing the genotype helps inform treatment recommendations and the duration of treatment. According to the Centers for Disease Control and Prevention, HCV infection becomes chronic in approximately 75 to 85 percent of cases. Patients who suffer from chronic HCV infection over many years may have complications, such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, liver cancer and death.

Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013 as Sovaldi, and velpatasvir, a new drug, that is the first one on the market to treat all six HCV genotypes.

The prevalence of HCV genotypes varies regionally throughout the world. In resource-limited settings, genotype testing can often be costly or unreliable, posing yet another barrier to treatment. As a pan-genotypic therapeutic option, Epclusa eliminates the need for genotype testing and has the potential to accelerate access to treatment for patients worldwide.

Approval of Epclusa is a breakthrough for patients with genotype 2 and 3, who previously required more complex and costly regiments and now can be treated with one tablet formulation.

Epclusa has been priced around $75,000 for a full course 12-week therapy. This price is about $10,000 less than Sovaldi and $20,000 less than Harvoni. Since Epclusa treats all genotypes of hepatitis C it is most likely to become the preferred drug for treatment.

Gilead hopes to continue to dominate the Hepatitis C market despite competition. Merck’s Zepatier, which was released earlier this year and priced at $54,000 per 12 week course of therapy, may be a competitor for Epclusa when it comes to genotype 1. However, it has a good potential of becoming a primary treatment option for genotypes 2-6.

The most common side effects of Epclusa include headache and fatigue. Epclusa and ribavirin combination regimens are contraindicated for patients for whom ribavirin is contraindicated.

Epclusa carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral. Co-administration of amiodarone with Epclusa is not recommended. Epclusa also carries a warning not to use with certain drugs that may reduce the amount of Epclusa in the blood which could lead to reduced efficacy of Epclusa.

 


Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

Drug News: FDA Approvals & Generic Launches March 2016 – June 2016
FDA has approved Zepatier - New treatment for chronic hepatitis C