The hepatitis C medication Harvoni has now been approved by the FDA to be used in liver transplant patients.
The FDA approved Harvoni (ledipasvir/sofosbuvir) for two new indications that will expand its use in liver transplant patients with HCV as well as those with decompensated cirrhosis, who generally have a poor prognosis and often go on to require a liver transplant.
Previously treatment options in these patients have been limited and often involved injectable and hard-to-tolerate interferon alpha therapy. Now they will be able to receive a 12-week, oral course of Harvoni, expanding the target patient population for a drug that brought in nearly $14bn in sales last year.
Specifically, the US regulator has approved Harvoni in combination with ribavirin chronic HCV genotype (GT) 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis, as well as for GT 1-infected patients with decompensated cirrhosis, including those who have received a liver transplant.
Gilead has been expanding the use of Harvoni as the drug starts to face competition from rival oral HCV therapies, including AbbVie’s Viekirax/Viekira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) and Merck & Co’s recently-approved Zepatier (elbasvir/grazoprevir), which has undercut Harvoni on price.
Last November, the FDA approved Harvoni for expanded use in patients with genotype 4, 5, and 6 chronic HCV infections and in patients co-infected with HIV. It also cleared a 12-week Harvoni and ribavirin regimen as an alternate therapy to 24 weeks of Harvoni for treatment-experienced genotype 1 patients with cirrhosis.
Read Full Article: Harvoni cleared for broader use in hepatitis C – PMLiVE