FDA Approves Pill for all Hepatitis C Forms

04.07.2016 -

The US Food and Drug Administration has approved Gilead Sciences’ combination pill Epclusa, the first to treat all major forms of hepatitis C. This is the latest in a series of drug approvals expected to revolutionize treatment of the disease. As Gilead’s pill can be taken by all hepatitis C sufferers, with and without liver damage, it is expected to be easier to use than five other hepatitis drugs recently approved by the FDA, each of which is tailored to different viral strains or stages of liver disease.

The US company’s two earlier drugs already have successfully replaced an older, less effective treatment that involved a mixture of tablets and injections; however, insurers have balked at the high price. 

At $74,760 for a 12-week course of treatment, or about $890 per pill, Epclusa will cost less than the initial cost of $1,125 per pill for Gilead’s second drug, Harvoni. The company’s first hepatitis C drug, Sovaldi, cost roughly $1,000 per pill.

Since 2014, the FDA has approved hepatitis drugs made by AbbVie, Merck & Co and Bristol-Myers Squibb. In January, the European Medicines Agency (EMA) gave the green light for AbbVie's hepatitis C treatment Viekira Pak to be prescribed for patients with the genotype 1 form of hepatitis C. The drug was approved by the US Food and Drug Administration FDA in December 2014.

Gilead and AbbeVie have recently engaged in price wars as they fought for market share. This, observers said, has help made the hepatitis treatment more affordable. Merck & Co earlier this year won a patent dispute against Gilead over sofosbuir, the active ingredient in Gilead’s Solvadi and Harvoni.

Epclusa combines Sovaldi with a new drug that attacks the virus using a different mechanism. It is designed to be used in combination with ribavirin, an older antiviral drug. The new drug is capable of treating all six genetic subtypes of the virus and curing 95% of patients in three months, according to clinical trial data reviewed by the FDA.

IMS Health calculates that Harvoni was the world’s top-selling prescription drug last year, with Sovaldi ranked eighth.