Drug maker Hetero has received approval from DCGI to market generic version of Gilead’s Harvoni, a drug used in the treatment of Hepatitis C in India. Hetero is the first Indian company to receive the approval for the fixed-dose combination Ledipasvir-Sofosbuvir (90mg/400mg) from Drug Controller General of India (DCGI). Following the non-exclusive licensing agreement signed with Gilead Sciences in September last year, to manufacture and market chronic hepatitis C medicines, Hetero is all set to launch the fixed-dose combination therapy Ledipasvir-Sofosbuvir for Indian patients.

The product will be available under the brand name ‘Ledisof’. It is much more effective than the existing Sofosbuvir. This fixed-dose combination is the generic version of Gilead’s brand Harvoni, approved by USFDA. India alone, it is estimated that 12-18 million patients are infected with Hepatitis C which is several fold greater than those with HIV/AIDS Untreated chronic hepatitis C increases the risk of cirrhosis of liver, liver failure and hepatocellular carcinoma.

Hepatitis C 

• Hepatitis C is an infectious disease affecting primarily the liver, caused by the hepatitis C virus (HCV).
• HCV is spread primarily by blood-to-blood contact associated with intravenous drug use, poorly sterilized medical equipment, and transfusions.
• An estimated 150–200 million people worldwide are infected with hepatitis C.
• Hepatitis C is the leading reason for liver transplantation, though the virus usually recurs after transplantation.

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The Hepatitis Day is observed on __________.

The 2015 Theme is “Prevent hepatitis. Act now”