The Food and Drug Administration (FDA) has approved Harvoni (ledipasvir and sofosbuvir; Gilead) and Sovaldi (sofosbuvir; Gilead) for use in younger patients with chronic hepatitis C virus (HCV).
Specifically, Harvoni is now indicated for use in patients 3 years of age and older with: HCV genotypes 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis; genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin; and genotype 1 or 4 infection in liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin.
In pediatric patients, Sovaldi is now approved for the treatment of chronic HCV genotype 2 or 3 infection in patients 3 years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. In adults, Sovaldi is also indicated for use in patients with HCV genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin.
Data from pediatric trials evaluating Harvoni and Sovaldi for their approved pediatric populations showed that the safety, pharmacokinetics, and efficacy of both treatments were comparable to that observed in adult patients.
In addition to the pediatric indications, a new oral pellet dosage formulation has been approved for both Harvoni and Sovaldi. The pellets may be sprinkled on food that is non-acidic (ie, pudding, chocolate syrup, mashed potato, ice cream) and at or below room temperature. Harvoni pellets will be available in 45mg/200mg and 33.75mg/150mg strength packets. Sovaldi pellets are supplied in 150mg and 200mg strength unit-dose packets.
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