FDA approves two indications for Harvoni use in patients with HCV and advanced liver disease

Gilead Sciences announced the FDA has approved two additional indications for Harvoni for the treatment of adults with chronic hepatitis C virus infection with advanced liver disease. The indications allow for the treatment of liver transplant recipients with genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis, and for genotype 1-infected patients with decompensated cirrhosis.

“Hepatitis C-infected patients who have decompensated cirrhosis and those who have previously received a liver transplant have an urgent need for treatment, but historically their options have been limited,” Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead Sciences, said in a press release. “We are pleased that health care providers now have the information needed to offer these patients an all-oral, 12-week duration therapy with high cure rates and a tolerable side effect profile.”

The new indications for Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) are supported by data from the phase 2 SOLAR-1 and SOLAR-2 clinical trials, in which treatment-naive and treatment-experienced patients with genotype 1 and 4 infection were treated with Harvoni, plus ribavirin, for 12 and 24 weeks, according the release.

In the SOLAR-2 trial, SVR12 rates in the non-cirrhotic or compensated arm for genotype 1 patients were 96% after 12 weeks of treatment and 98% after 24 weeks of therapy. SVR12 rates for genotype 1 patients in the more severe group were 88% after 12 weeks of treatment and 89% after 24 weeks of treatment, according to data presented at the International Liver Meeting 2015.

The treatment regimen is now approved for the treatment of HCV in various patient populations including genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, liver transplant recipients with genotype 1 or 4 infection and patients with genotype 1 infection with decompensated cirrhosis.

Disclosure: Bischofberger is employed by Gilead Sciences.