FDA approves the first pill to treat all major forms of hepatitis C

WASHINGTON — Federal health officials on Tuesday approved the first pill to treat all major forms of hepatitis C, the latest in a series of drug approvals that have reshaped treatment of the liver-destroying virus.

The Food and Drug Administration approved the combination pill, Epclusa, from Gilead Sciences for patients with and without liver damage. The new drug’s broad indication could make it easier to use than five other hepatitis drugs recently approved by the FDA, which are each tailored to different strains or stages of liver disease.

Gilead’s previous two hepatitis drugs have raked in billions of dollars by replacing an older, less effective treatment that involved a grueling pilland-injection cocktail. But the company’s aggressive approach to pricing has drawn scorn from patient groups, insurers and politicians worldwide.

The company said Epclusa will cost $74,760 for a 12-week course of treatment, or roughly $890 per pill. That’s less than the initial price for company’s previous drug, Harvoni, which cost $1,125 per pill. Gilead’s first hepatitis C drug, Sovaldi, cost roughly $1,000 per pill, touching off a national debate about escalating drug costs.

Since 2014, the FDA has approved rival medications from AbbVie Inc., Merck & Co., and BristolMyers Squibb Co. that have helped curb prices.

Hepatitis C affects at least 2.7 million people in U.S. and caused more than 19,000 deaths in 2014, according to the Centers for Disease Control and Prevention. The virus develops slowly over decades and many people don’t realize they are infected until signs of liver damage emerge, including yellowish skin, dark urine and fatigue. Some develop liver cancer or cirrhosis and require a liver transplant, but many die before a match is available. Baby boomers are five times more likely to have the virus than people in other age groups.

Gilead’s new pill combines Sovaldi with a new drug that attacks the virus using a different mechanism. The daily pill cures 95 percent of patients in three months, according to clinical trial data.