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’sViekirax/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.
All told, Harvoni and Sovaldi (sofosbuvir) have been used to treat more than 750,000 patients with HCV around the world and the success of the new oral HCV therapies have raised the real prospect of eradicating HCV.
Despite the number of patients treated to date, there are still millions of HCV-infected individuals who have yet to be treated and many that have yet to be diagnosed, according to Gilead, which believes HCV will remain a sustainable market for the foreseeable future.
The company is also hoping to launch a follow-up to Harvoni, which covers a broader range of HCV genotypes and should extend the franchise.