WASHINGTON: Doctors may soon have two new drug options for patients with hepatitis C, just as the liver-destroying virus becomes a major public health concern for millions of baby boomers.
The Food and Drug Administration holds 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 reported that J&J’s drug simeprevir has a slightly higher cure rate 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 hepatitis C, and people born between 1945 and 1965 are five times more likely to have it than people of other age groups, according to the Centers for Disease Control and Prevention.
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 after liver damage has occurred, causing abdominal pain, fatigue, itching and dark urine.
For most of the last 20 years, the standard treatment involved a grueling one-year regimen of pills and injections that caused flu-like symptoms and cured less than half of patients. Many patients failed to complete the full treatment cycle. Others delayed starting treatment at all in the hopes that more effective treatments would come along.
Two drugs approved in 2011 when added to the older drug cocktail can boost cure rates to between 65 and 75 percent. The drugs the FDA is reviewing this week have the potential to push cure rates higher.
J&J’s simeprevir cured 80 percent of patients not previously treated for hepatitis C, the FDA’s review says. Sofosbuvir, the drug from Gilead Sciences, could become the first choice in treatment, some analysts say. It has been shown to cure up to 90 percent of patients after 12 weeks, according to a company study.