US indication for ledipasvir/sofosbuvir expanded

Gilead press release

On 12 November 2015 the US FDA approved an expanded indication for the fixed combination of ledipasvir/sofosbuvir.

The expanded indication now includes treatment for genotype 4, 5 and 6 and for HIV/HCV coinfection

In addition, ledipasvir/sofosbuvir plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of ledipasvir/sofosbuvir for treatment-experienced, genotype 1 patients with cirrhosis.

The dual formulation is manufactured by Gilead and marketed under the brand name Harvoni.


Gilead press statement. U.S. FDA approves new indications for Harvoni, Gilead’s once-daily single tablet regimen for chronic hepatitis C. (12 November 2015).

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