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U.S. Food and Drug Administration to Review Two New Drugs for Hepatitis C as Virus Becomes Health Concern for Baby Boomers

October 23, 2013

This article was recently reported by the Washington Post.

The US Food and Drug Administration (FDA) this week planned to review two new drugs to treat hepatitis C. If approved, the drugs would offer a faster and more effective method to curing the blood-borne liver disease, which has become a major health concern for millions of baby boomers. Hepatitis C was responsible for approximately 15,000 US deaths this year.

Johnson & Johnson (J&J) and Gilead Sciences submitted their latest experimental drugs that had the potential to treat the 3-4 million infected Americans. Health officials encouraged baby boomers to get tested because the virus could lie dormant for decades before causing health problems or symptoms. Health officials believed baby boomers contracted the disease through sex or sharing needles in their youth, or by having blood transfusions before 1992, which was when medical facilities began testing all donated blood for hepatitis.

"If something is not done soon, all these people who were infected in the 60s and 70s are going to start experiencing the long-term consequences of liver disease," said Gaston Picchio, head of hepatitis drug development for J&J's Janssen Therapeutics unit.

Hepatitis C treatments throughout the past 20 years have involved a difficult one-year regimen of both pills and injections that have unpleasant side effects and only cure approximately half of the patients. Two drugs, introduced in 2011 and taken concurrently with the previous regimen, boosted the cure rate to up to 75 percent. J&J's drug, simeprevir, had a somewhat better cure rate than current treatments, as well as cut the treatment cycle in half, but side effects included rashes and sunburns. FDA planned to ask a panel of experts if the drug should carry a warning label. Gilead Sciences Inc.'s drug, sofosbuvir, had a 90-percent cure rate with only 12 weeks of therapy, which led analysts to believe this drug might become the therapy of choice to treat the disease.

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Excerpted from:
Washington Post
10.22.2013; Associated Press

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