Bristol-Myers Squibb’s Daklinza has been cleared in Europe for the treatment of chronic hepatitis C in three new difficult-to-treat patient populations.
The drug’s expanded label now includes use of the drug in combination with sofosbuvir (Gilead’s Sovaldi, with or without ribavirin) in hepatitis C (HCV) patients with decompensated cirrhosis, HIV-1 co-infection, and post-liver transplant recurrence.
Daklinza (daclatasvir) is already approved in Europe for use in combination with other therapies across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults, and the Daklinza/sofosbuvir regimen is the only approved 12-week, all-oral treatment for genotype 3 HCV patients without cirrhosis.
The new indications are based on data from the Phase III ALLY clinical trials, which showed high sustained virologic response (SVR) rates across the patient subsets.
In ALLY-2, the Daklinza/sofosbuvir regimen demonstrated overall SVR12 in 97% of patients co-infected with HIV, including 100% in genotype 3, and SVR12 rates were found to be greater than 94% across all combination antiretroviral therapy regimens, BMS said.
In ALLY-1, 94% of post liver-transplant patients and 83% of patients in the cirrhosis cohort achieved SVR12.
The drug’s expanded approval “is an important step forward for a significant group of patients with chronic hepatitis C who are still in need of treatment options that can deliver high cure rates,” noted Douglas Manion, head of Specialty Development, BMS.
“The complex clinical considerations for physicians treating HCV/HIV coinfected patients and patients with cirrhosis, decompensated cirrhosis or post-transplant recurrence of HCV reinforces the vast diversity of this disease, and we have worked hard to continue to identify and address those patients who require additional solutions for cure.”