FDA Approves Sovaldi and Harvoni for Pediatric Hepatitis C Patients

FDA Approves Sovaldi and Harvoni for Pediatric Hepatitis C Patients

Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) were recently added to the list of approved medications for the treatment of hepatitis C virus (HCV) in pediatric patients ages 12 to 17 by the U.S. Food and Drug Administration (FDA).

Sovaldi and Harvoni are the first direct-acting antiviral treatments approved for pediatric HCV patients. Direct-acting antiviral drugs are designed to reduce the amount of HCV in the body by preventing the virus from multiplying.

Both drugs are produced and commercialized by Gilead, and are already approved for the treatment of HCV in adult patients.

The two drugs are now also indicated for children ages 12 and older who weigh at least 77 pounds (35 kg).

Sovaldi can be administered with or without ribavirin, and it is indicated for the treatment of HCV genotypes 2 and 3. The effectiveness of the therapeutic combination of Sovaldi plus ribavirin was evaluated in a clinical trial enrolling 50 pediatric patients with results comparable to those found in adults. In a follow-up 12 weeks after finishing treatment, 100 percent of patients with HCV genotype 2 and 97 percent of patients with HCV genotype 3 had no virus detected in their blood.

Harvoni is indicated for pediatric patients with the HCV genotypes 1, 4, 5 or 6 who have no cirrhosis or mild cirrhosis.

The safety, pharmacokinetics and effectiveness of Harvoni for the treatment of HCV genotype 1 were established in a trial enrolling 100 pediatric patients. Results were comparable to those observed in adults – 98 percent of patients had no signs of HCV in their blood 12 weeks after treatment.

For the assessment in the HCV genotypes 4, 5 and 6, safety and effectiveness were measured based on data showing similar results in adults and teens with HVC genotypes 1, 4, 5 and 6.

The most common adverse events observed with the combination treatment Sovaldi plus ribavirin, as well as with Harvoni, were fatigue and headache.

“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” Edward Cox, MD, director of the FDA’s Office of Antimicrobial Products, said in a press release.

In other related news, the European Public Health Alliance (EPHA) plus 30 other civil society organizations from 17 European countries recently filed a coordinated patent opposition on Sovaldi and Harvoni contesting the high prices of the drugs. Results of this initiative might translate into more accessible treatments for European patients.

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