Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved Daklinza (daclatasvir) for use in combination with sofosbuvir with or without ribavirin, for the treatment of chronic hepatitis C genotypes 1 and 3. 

The updated label now includes data from 3 challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 co-infection, advanced cirrhosis, or post-liver transplant recurrence of HCV. 

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The expanded approval was based on efficacy and safety data from the Phase 3 ALLY-1 and ALLY-2 trials. ALLY-1 evaluated patients with chronic HCV infection and Child-Pugh A, B, or C advanced cirrhosis or HCV recurrence after liver transplant treated with Daklinza plus sofosbuvir with ribavirin for 12 weeks. The primary endpoint was SVR12, and rates were comparable between genotype 3 and genotype 1 subjects with or without decompensated cirrhosis.

ALLY-2 evaluated treatment-naïve and treatment-experienced HCV/HIV co-infected patients treated with Daklinza plus sofosbuvir for 12 weeks. SVR was the primary endpoint and was defined as HCV RNA below the LLOQ at post-treatment Week 12 (SVR12) in genotype 1 treatment-naïve patients. SVR12 rates were high regardless of baseline subgroup and high baseline viral load (≥6,000,000 IU/mL). In addition, SVR12 were also similar among the concomitant HAART (highly active antiretroviral therapy) regimens used, 

The Daklinza (HCV NS5A inhibitor) plus sofosbuvir (HCV NS5B polymerase inhibitor) regimen is already indicated for the treatment of chronic HCV genotype 3. Daklinza is available as 30mg and 60mg strength tablets in 28-count bottles.

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