FDA extends approval in Daklinza (daclatasvir) plus Sovaldi (sofosbuvir) to genotypes 1 and 3 chronic hepatitis C- BMS

Bristol-Myers Squibb announced that the FDA has expanded approval of Daklinza (daclatasvir, 60 mg), in combination with Sovaldi (sofosbuvir) with or without ribavirin, to patients with genotypes 1 and 3 chronic hepatitis C. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response (SVR) rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ribavirin. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir with or without ribavirin for 12 weeks.

The efficacy and safety of the Daklinza regimens were evaluated in the Phase III ALLY-1 and ALLY-2 clinical trials. In ALLY-2, SVR12 rates were high regardless of baseline subgroup, including Black/African-American (98%, n=50 in all genotypes studied), and high baseline viral load (97%, n=62 in all genotypes studied). Rates of SVR12 were also similar among the concomitant HAART (highly active antiretroviral therapy) regimens used, which included protease inhibitors (97%, n=70 in all genotypes), non-nucleoside reverse transcriptase inhibitors (100%, n=40 in all genotypes), and integrase inhibitors (95%, n=39 in all genotypes). Among the 153 patients in ALLY-2, there were no treatment-related serious adverse events (SAEs) and no discontinuations due to adverse events (AEs).

In ALLY-1, SVR12 rates were comparable between genotype 3 (5/6 with Child-Pugh B or C cirrhosis and 10/11 post-liver transplant) and genotype 1 subjects with or without decompensated cirrhosis. Among all patients in ALLY-1, there were no treatment-related SAEs. Of the 15 (13%) patients who discontinued study drug for adverse events, 13 (12%) patients discontinued ribavirin only and 2 (2%) patients discontinued all study drugs.