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FDA to review hepatitis C drugs

Public meeting for medications to be held this week

– Doctors may soon have two new drug options to treat patients with hepatitis C, just as the liver-destroying virus becomes a major public health issue for millions of baby boomers.

The Food and Drug Administration will hold a public meeting this week to review two experimental medications from Johnson & Johnson and Gilead Sciences. The new drugs, if approved, could offer a quicker, more effective approach to eliminating hepatitis C, a blood-borne disease blamed for 15,000 deaths in the U.S. this year.

In a review posted online Tuesday, the FDA said J&J’s drug simeprevir posted slightly higher cure rates than currently available treatments, though it also caused rashes and sunburn in some patients.

On Thursday the FDA will ask a panel of outside experts whether the drug should carry warnings about rashes and sunburn on its label. The agency is not required to follow the panel’s advice, though it often does.

The meeting comes at a time when federal health officials are urging baby boomers to get tested for the virus, which can go unnoticed for decades before causing symptoms.

Between 3 million and 4 million Americans are infected with the hepatitis C virus, and people born between 1945 and 1965 are five times more likely to have the virus than people of other age groups.

Many baby boomers contracted the virus by sharing needles or having sex with an infected person in their youth. The disease was also spread by blood transfusions before 1992, when blood banks began testing for the virus.

“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.

Most people with hepatitis C do not even know they have the virus until liver damage has occurred, causing abdominal pain, fatigue, itching and dark urine.

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