Bloomberg news service reported that Gilead Sciences Inc.’s hepatitis C drug was approved by U.S. regulators for all forms of the viral disease, making it the first treatment with a comprehensive label.

Hepatitis C is a viral infection of the liver that causes inflammation. According to the Centers of Disease Control (CDC), approximately 75-80% of hepatitis C infections become chronic, which can, over time, lead to liver damage, liver cancer, and even death. A reduction in the volume of the hepatitis C virus in the body can decrease progression of liver damage and its effects, including liver cancer; therefore, anti-viral therapy is an important approach to treatment.

According to the FDA, Epclusa can be used by patients with any of the six genotypes of hepatitis C, which affects 130 million to 150 million people globally.

This is a significant advancement, particularly for patients with genotype 3, the hardest-to-treat form of the disease, and genotype 2, which currently often requires the addition of another treatment. Genotype 1 is the most prevalent worldwide, accounting for about 46 percent of cases globally, followed by genotype 3, affecting about 30 percent. ¹

Epclusa combines Sovaldi with a new treatment called velpatasvir. The tablet can be used in combination with ribavirin and carries a warning about serious slowing of the heart rate and cases requiring pacemaker intervention when used with amiodarone, a drug for heart rhythm problems, the FDA said in its statement.

Patients with genotype 3 are typically treated with a combination of Sovaldi and Daklinza with a list price of ~$147,000 for a 12-week regimen. Gilead has set a list price of $74,760 for a 12-week course of treatment, which is lower than the list prices of its best-selling treatments Sovaldi, at $84,000, and Harvoni, $94,500. ²

Even though Epclusa is approved for patients with all genotypes of the drug, Harvoni will continue to be the standard of care for patients with genotype 1, Milligan said, particularly because Harvoni has an 8-week treatment course for some patients, while Epclusa has only been approved for 12 weeks.

References:

1. Messina J, Humphreys I, Flaxman A, et al. Global Distribution and Prevalence of Hepatitis C Virus Genotypes. Hepatology. 2015 Jan; 61(1): 77–87. Abstract. doi:  10.1002/hep.27259
2. http://www.bloomberg.com/news/articles/2016-06-28/gilead-wins-fda-approval-of-hepatitis-c-drug-for-all-genotypes

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