New option approved for liver transplant patients and individuals with decompensated cirrhosis.
The FDA has approved additional indications for ledipasvir/sofosbuvir (Harvoni), to treat patients with chronic hepatitis C virus (HCV) and advanced liver disease.
Harvoni, which is used in combination with ribavirin (RBV) for 12 weeks, is now approved to include patients with HCV genotypes 1, 4, 5, and 6; HCV/HIV-1 coinfection; patients with HCV genotypes 1 and 4 who received a liver transplant; and HCV genotype 1 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,” said Norbert Bischofberger, PhD, of Gilead. “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 approval followed the Phase 2 SOLAR-1 and SOLAR-2 trials. The clinical trials included patients with HCV genotypes 1 and 4 who were treatment naïve and treatment experienced and who received a liver transplant and/or had decompensated liver disease. These patients were administered the combination of Harvoni and RBV for 12 and 24 weeks.
The SVR12 rates for genotype 4 post-transplant patients without cirrhosis or compensated cirrhosis (n=12) were similar to rates of SVR12 in genotype 1 patients. The results for genotype 4 with decompensated cirrhosis either pre or post liver transplantation were insufficient.
There were 7 patients total who had fibrosing cholestatic hepatitis in the SOLAR-1 and SOLAR-2 trials.
For adverse events, 1% and 2% of patients with liver transplants and decompensated liver disease, respectively, discontinued the regimen. The most common adverse reactions (≥10%, all grades) were asthenia, headache, and cough.