Posted from: Thursday, May 04, 2017 - 04:26 PM - Present

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.

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.

Last Updated Wednesday, July 26, 2017 - 11:02 PM.