转载姜皓文第二弹:U.S. FDA approves first new hepatitis C drug ...

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U.S. FDA approves first new hepatitis C drug in 20 years

14:51, May 14, 2011      

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The U.S. Food and Drug Administration (FDA) on Friday approved Victrelis to treat certain adults with chronic hepatitis C, which is the first new treatment approved for the disease in the United States in 20 years.

Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. It is approved for use in combination with peginterferon alfa and ribavirin.

The safety and effectiveness of Victrelis was evaluated in two phase three clinical trials with 1,500 adult patients. In both trials, two-thirds of patients receiving Victrelis in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response, compared to pegylated interferon and ribavirin alone, the current standard of care.

When a person sustains a virologic response after completing treatment, this suggests that hepatitis C virus infection has been cured. Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer, and decreased mortality.

"Victrelis is an important new advance for patients with hepatitis C," said Edward Cox, director of Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' hepatitis C infection compared to currently available therapy."

The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin include fatigue, low red blood cell count, nausea, headache and taste distortion. The drug is marketed by Merck.

According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.

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