WASHINGTON - The Food and Drug Administration on Friday approved a highly anticipated hepatitis C drug from Merck that is the first new treatment for the virus in 20 years.
The first-of-its-kind pill, Victrelis, has been shown to cure more patients in less time than the older drugs now used.
About 3.2 million people in the United States have hepatitis C, a blood-borne disease linked to 12,000 deaths a year. The current two-drug treatment for the virus cures only about 40 percent of people and causes side effects like nausea, fatigue and vomiting.
The FDA said it approved the new drug based on two trials in which more than 65 percent of patients were cured when combining Victrelis with the two older drugs. Some patients were also able to eliminate the virus in seven months on the drug, nearly half the time needed with the current treatments alone.
The drug, known generically as boceprevir, is designed to be taken three times a day with meals. Side effects include fatigue, nausea, headache and low blood cell count.
Hepatitis C is the primary cause of liver transplants in the United States. Most people with hepatitis C don't know they have the virus until after liver damage has occurred, which can cause abdominal pain, fatigue, itching and dark urine.