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Hepatitis C Update: FDA Approves Gilead's New Drug to Treat All Form of Hepatitis C

Jun 29, 2016 09:03 AM EDT
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The United States Food and Drug Administration have recently approved a combination drug developed by Gilead to treat all the six major forms of Hepatitis C.

The new drug, dubbed as Epclusa, is fixed-dose combination tablet containing sofosbuvir and velpatasvir. It has been approved by the FDA to be used as treatment for adult patients with chronic hepatitis C virus with or without advanced liver disease.

"This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C," said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a press release.

According to the report from Reuters, Epclusa recorded 95 to 99 percent cure rates in patients with or without mild damage in the liver after 12 weeks of treatment during the clinical trial period. In a separate trial involving different set of patients with moderate to severe liver damage, Epclusa in combination with the drug ribavirin led to 94 percent cure rates.

FDA reported that the most common side-effects of Epclusa include headache and fatigue.FDA has also recommended against co-administration of amiodarone with Epclusa. There have been previous reports that using amiodarone in combination with sofosbuvir together with another HCV direct-acting antiviral may cause serious slowing of heart rate, which may lead to peacemaker intervention. Epclusa are also not be used with other drugs that may reduce the amount of Epclusa in the blood that could result in reduced efficacy of Epclusa.

Although the efficacy of Epclusa has been proven and approved by FDA, many patients with hepatitis C may not get their hands on the new life-saving drug due to its immense pricing. Gilead announced that Epclusa will cost around $74,760 for a 12-week course of treatment, which is roughly $890 for each pill.

However, Epclusa is definitely cheaper than its predecessors Harvoni and Sovaldi, which costs $1,125 and $1000 respectively.

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