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Hepatitis C drug called a ‘miraculous advance’

Posted in News, Uncategorized with tags , , on May 4, 2011 by punauni

SILVER SPRING, Md. — A new treatment for hepatitis C could soon be on the market if the Food and Drug Administration takes the advice of an advisory committee.

The committee unanimously approved the first of two new drugs to treat chronic hepatitis C genotype 1 infection. Hepatitis C is a chronic viral disease that causes inflammation and swelling of the liver.

The drug, boceprevir, is a new class of protease inhibitor manufactured by pharmaceutical giant Merck & Co., and would be used in combination with ribavirin and peginterferon — the current standard of care. Boceprevir prevents the virus from replicating, and studies show the three-drug cocktail is more effective than the two-drug regimen.

According to Merck, about 66 percent of study patients that hadn’t been treated or did not respond well to current treatment responded well to boceprevir.

The FDA’s outside panel of experts considered the risks and benefits of the drug and determined the benefits far outweigh the risks.

“The benefit for the people who do achieve sustained virologic response is fantastic,” said Dr. Elizabeth Connick, University of Colorado Denver. “This is a miraculous advance.”

“The risks are not trivial, but we do know how to manage these risks. Still, there is a lot to learn about using these drugs appropriately,” said Dr. Thomas Giordano of Baylor College of Medicine.

“This is going to be a real game changer for our hepatitis C practices, ” said Dr. Barbara McGovern, Tufts University School of Medicine. “I can’t wait to get back and talk to my patients about it.”

Even hard-to-treat patients like African Americans, and people with HIV and diabetes responded extremely well to the boceprevir combination therapy.

Dr. Nizar Zein, section head of hepatology at the Cleveland Clinic says the disease is of epidemic proportions and quite costly. Zein say the new medication will usher in a very important new era for treating the disease.

“We can now say for the first time that we can cure hepatitis C,” Zein said. “We are talking about complete cure, cure for life. Several studies have shown that once you achieve that endpoint, the sustained virological response, you will not get hepatitis C ever again and the risk of getting cirrhosis, needing liver transplant will go down substantially.”

But this is a powerful drug and a major concern is that drug resistance can develop in patients very quickly if the medication is not taken properly. The proposed dosage is 800 mg three times a day with food.

Treatment can be individualized but Zein says both doctors and patients need to be educated and clear about when and how this drug is to be taken. “If used inappropriately, the virus will rapidly develop resistance to these medications — rapidly, I mean 24 to 48 hours.”

Close attention was paid to the drug’s side effects. The most common, according to Merck included anemia, abnormally low white blood cell count, fatigue, nausea, headache, hair loss and an impaired sense of taste.

According to FDA’s Dr. Poonam Mishra, the most notable safety concern is the additional decrease in hemoglobin — the protein in red blood cells that carries oxygen. Hemoglobin levels lower than normal could mean anemia, bleeding or a number of other conditions.

The FDA is not bound by their advisory committee recommendations but often follow their advice