FDA approves breakthrough treatment for hepatitis C

By Sarah Mayberry, M.P.H., Local 4 Health Producer, @4goodhealth
Published On: Dec 06 2013 05:18:46 PM EST
Updated On: Dec 06 2013 06:16:00 PM EST

The FDA has approved a new drug for treatment of hepatitis C patients.

The U.S. Food and Drug Administration has approved a new drug called Sovaldi (sofosbuvir) to treat chronic hepatitis C infections.

It's the first drug approved to treat certain types of hepatitis C without the need for interferon too, a drug which can cause severe side effects.

"Today's approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C," said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

The hepatitis C virus can lie silently in the body for decades, then suddenly cause life threatening liver failure.

Several years ago, professor Onaiwu Ogbomo found out he had hepatitis C during a routine screening. He developed liver failure and was saved by a liver transplant, but when the hepatitis C recurred with a vengeance, his doctors broke some hard news.

"There's every likelihood I might die, and in fact, they clearly informed me that I should get go home and get my things in order," said Ogbomo.

Because he was dying, Ogbomo's doctors were working behind the scenes to try and get him the then investigational drug sofosbuvir on a "compassionate use" basis.

"We were able to get the drug," said Dr. Dilip Moonka, a liver specialist at Henry Ford Hospital in Detroit. "We honestly feel if we had waited two or three more days that would have been too long."

Moonka said the drug sofosbuvir will revolutionize the treatment of hepatitis C.

"We expect to have cure rates of over 95 percent. We expect the treatments to be shorter, and we expect there to be fewer side effects," said Moonka.

Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. Sovaldi is intended to be used as a component of a combination antiviral treatment regimen for chronic hepatitis C infection. Depending on the type of infection a patient has, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin and peginterferon-alfa.

The most common side effects in the various treatments regimens were fatigue, headache, nausea, insomnia and anemia.

While anyone can get hepatitis C, according to the CDC, more than 75 percent of adults infected are Baby Boomers, people born from 1945 through 1965. Baby Boomers are encouraged to be tested, since most people with hepatitis C don’t know they are infected.

Currently there are between 3 and 4 million cases of hepatitis C in the United States, but that number could increase as more people get screened.

Experts said knowing there is what amounts to a cure for some patients will come as a relief to those battling the virus and those to come.

"They literally pulled me out of the grave," said Ogbomo.

To read the FDA approval of Sovaldi (sofosbuvir), click here.

To learn more about hepatitis C, click here.

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