The US Food and Drug Administration has expanded the approved uses for Bristol-Myers Squibb’s Daklinza to include three new subsets of difficult-to-treat patients with hepatitis C (HCV).
The regulator has cleared the drug’s use, in combination with sofosbuvir (Gilead’s Sovaldi, with or without ribavirin) in HCV patients with decompensated cirrhosis, HIV-1 co-infection, and post-liver transplant recurrence.
The Daklinza (daclatasvir) regimen is already available in the US for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients in the country.
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 expanded indication was also recently approved by regulators in Europe.