FDA expands use of hep C drug

February 10, 2016

FDA has approved expanded use of daclatasvir (Daklinza, Bristol-Myers Squibb) in combination with Gilead Sciences' Sovaldi (sofosbuvir), for the treatment of patients with chronic hepatitis C (HCV) genotype 1 or 3.

FDA has approved expanded use of daclatasvir (Daklinza, Bristol-Myers Squibb) in combination with Gilead Sciences' Sovaldi (sofosbuvir), for the treatment of patients with chronic hepatitis C (HCV) genotype 1 or 3.

The news comes 2 weeks after FDA approved Zepatier (elbasvir and grazoprevir, Merck) as a less-costly treatment in the fight against hepatitis C. Gilead’s Sovaldi and Harvoni, along with other hepatitis C medications, have come under fire by US legislators, patients and organizations for their high cost.

Related: Hepatitis C pricing heats up with new drug

The newly approved Daklinza-Sovaldi combination can be used with or without ribavirin to treat 3 new patient populations-chronic HCV patients with HIV-1 (human immunodeficiency virus) coinfection, advanced cirrhosis and post-liver transplant recurrence of HCV.

Daklinza plus sofosbuvir was previously approved for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients.

"Daklinza advances the treatment of chronic hepatitis C by providing new treatment options for challenging patient populations with remaining unmet needs, including HIV coinfected patients, patients with advanced cirrhosis, and post-liver transplant patients with HCV recurrence," said Douglas Manion, MD, head of specialty development, Bristol-Myers Squibb.

Related: Hepatitis C drugs come under fire again

The expanded FDA approval of Daklinza, in combination with sofosbuvir, is based on efficacy and safety data presented in 2 phase 3 clinical trials, ALLY-1 and ALLY-2. These trials studied Daklinza’s effect on sustained virologic response (SVR) in HCV/HIV-coinfected patients, patients with chronic HCV infection, as well as patients with Child-Pugh A, B, or C advanced cirrhosis.

The recommended dosing regimen for Daklinza is 60 mg in combination with sofosbuvir with or without ribavirin for 12 weeks.

Daklinza is contraindicated in combination with drugs that strongly induce CYP3A, such as phenytoin and carbamazepine, as they can decrease the efficacy of Daklinza. There is also an increased risk of symptomatic bradycardia when Daklinza is co-administered with sofosbuvir and amiodarone.

Read more: FDA approves Harvoni for new uses