Sovaldi and Harvoni Approved for Pediatric Hepatitis C
April 7, 2017 – The U.S. FDA approved the use of Gilead’s Sovaldi® (sofosbuvir) and Harvoni® (ledipasvir/sofosbuvir) for treating hepatitis C virus (HCV) infections in patients as young as 12 years of age, or at least 77 pounds (35kg). Both are oral direct-acting antiviral drug regimens for treating HCV infections. Harvoni can be used in children who have genotype 1, 4, 5 or 6 chronic HCV infections. Sovaldi is indicated for use, in combination with ribavirin, in pediatric patients with genotype 2 or 3 chronic HCV infection. According to the Centers for Disease Control and Prevention (CDC), an estimated 23,000 to 46,000 children in the U.S. are infected with HCV, usually infected at birth.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.