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According to the U.S. Department of Health and Human Services, there are 17,000 new cases of hepatitis in the United States each year. Moreover, approximately 3.2 million individuals in the U.S. are living with chronic hepatitis. It is spread primarily by contact with infected blood, as may occur through sharing needles or razors, and it also is transmitted largely through sexual contact.
Hepatitis C is an infectious disease affecting primarily the liver, caused by the Hepatitis C virus (HCV). Chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years. In some cases, those with cirrhosis will go on to develop liver failure, liver cancer or life-threatening esophageal and gastric conditions.
Gilead Sciences makes sofosbuvir, a drug to treat Hepatitis C. The FDA has concluded that Gilead Sciences Inc’s sofosbuvir drug is safe and effective when used in combination with other therapies to treat hepatitis C. The FDA review was posted on the FDA website and a panel of medical experts will now consider and recommend whether or not the agency should approve the drug.
“The currently available data support a favorable benefit-risk assessment for the use of sofosbuvir as part of a combination regimen for the treatment of chronic hepatitis C,” the FDA reviewers said. “No major safety issues associated with sofosbuvir use have been identified to date.”