Sovaldi and Harvoni Approved to Treat Hepatitis C in Pediatric and Adolescent Patients
In early April, the FDA announced that it had approved Gilead Sciences’ two highly effective hepatitis C drugs, Sovaldi and Harvoni, for use in treating patients ages 12 to 17. These direct-acting antiviral treatments are the first to be approved for youth with the hepatitis C virus (HCV).
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Although HCV rates in children are significantly lower than in adults, the American Liver Foundation estimates that as many as 46,000 children in the U.S. could be infected with the virus. The youngest patients are most likely to have been infected at birth, but those who acquire the virus as adolescents are likely to have engaged in behaviors such as IV drug use and high-risk sexual behavior.
As a result of these approvals, pediatric and adolescent care providers now have treatment options for six of the major HCV genotypes. According to the FDA release, Harvoni is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 77 pounds with HCV genotype 1, 4, 5, or 6 infection and no or mild cirrhosis. Sovaldi, in combination with ribavirin, is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 77 pounds with genotype 2 or 3 infection and no or mild cirrhosis.
CareTend, which helps specialty pharmacies manage their high-cost medications and monitor patient adherence, can help you care for your pediatric and adolescent HCV patients. Learn more at www.mediware.com/sprx.