Gilead announced that the Food and Drug Administration (FDA) has expanded the use of Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, aged ≥12 years or weighing ≥35kg.
Harvoni has been approved for pediatric patients with HCV genotype 1, 4, 5 or 6 infection. Sovaldi has been approved for pediatric patients with HCV genotype 2 or 3 infection, in combination with ribavirin.
“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
The expanded approval of Harvoni was based on data from Study 1116, an open-label trial that evaluated 12 weeks of Harvoni once-daily in genotype 1 treatment-naive and treatment-experienced HCV-infected adolescents without cirrhosis or with compensated cirrhosis. The rate of SVR12 was 98% overall with no patients experiencing on-treatment virologic failure or relapse.
The expanded approval of Sovaldi was based on data from Study 1112, an open-label trial that evaluated 12 or 24 weeks of Sovaldi and weight-based ribavirin in adolescents with HCV genotypes 2 or 3. The rate of SVR12 was 100% in genotype 2 patients and 97% in genotype 3 patients with no patients experiencing on-treatment virologic failure or relapse.
The most common adverse reactions observed with treatment were fatigue and headache. Both Harvoni and Sovaldi carry a boxed warning regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV co-infected patients.
Harvoni is available as 90mg/400mg strength tablets in 28-count bottles. Sovaldi is available as 400mg strength tablets in 28-count bottles.