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June 29, 2016

Gilead’s Epclusa receives FDA approval to treat genotype I-VI chronic HCV

American biopharmaceutical company Gilead Sciences has received the US Food and Drug Administration (FDA) approval for Epclusa (sofosbuvir 400mg / velpatasvir 100mg) to treat adults affected with genotype I-VI chronic hepatitis C virus (HCV) infection.

By Lopamudra Roy

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American biopharmaceutical company Gilead Sciences has received the US Food and Drug Administration (FDA) approval for Epclusa (sofosbuvir 400mg / velpatasvir 100mg) to treat adults affected with genotype I-VI chronic hepatitis C virus (HCV) infection.

Epclusa is the first all-oral, pan-genotypic, single tablet regimen, which is also used to treat patients with HCV genotype II and III, without the need for ribavirin.

Use of the tablet for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C).

As a pan-genotypic therapeutic option, Epclusa not only removes the need for costly and unreliable genotype testing but also has the ability to accelerate access for the treatment of patients worldwide.

Gilead President and CEO Dr John Milligan said: "Today’s approval represents a significant advance for patients with HCV genotypes II and III, who previously required more complex and costly regimens.

"We look forward to making Epclusa available to patients around the world as quickly as possible."

"As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings.

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"We look forward to making Epclusa available to patients around the world as quickly as possible."

The FDA has given Gilead Sciences’ Epclusa a Priority Review and Breakthrough Therapy designation, which is given to investigational medicines that provides better advances in treatment over existing options.

However, the Epclusa tablet should not be administered in combination with ribavirin in patients for whom ribavirin is contraindicated.


Image: Epclusa is the first and only all-oral, pan-genotypic single tablet regimen for HCV. Photo: courtesy of Gilead.

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