The FDA has approved supplemental applications for Gilead’s Harvoni and Sovaldi – both treatments for chronic hepatitis C infection – for pediatric patients age 12 and over. Adolescents may, or may not, have compensated cirrhosis, and must weigh at least 35kg to be eligible for treatment with the drugs.
According to the FDA, there are 23,000 to 46,000 US pediatric patients suffering from a chronic hepatitis C virus infection, the majority of whom likely contracting the virus at birth. The FDA approved Harvoni to treat patients with genotype 1, 4, 5 or 6 hepatitis C infection, while Sovaldi was approved for patients with genotype 2 or 3.
“The approvals of Sovaldi and Harvoni for pediatric patients will enable adolescents to finally benefit from interferon-free treatment for HCV infection,” said Dr. Karen Murray, professor of pediatrics at the University of Washington School of Medicine and Seattle Children’s. “These therapies address a significant unmet medical need and represent an important advance for HCV-infected adolescents.”
Harvoni and Sovaldi were both previously approved to treat adult patients with chronic hepatitis C infection. These drugs belong to a class of direct-acting antivirals, which act to reduce the viral load by inhibiting its ability to replicate. Because of this mode of action, these drugs are effective cures for hepatitis C infections in most cases.
“Gilead’s goal is to develop and deliver treatments that provide all patients with hepatitis C virus the potential to be cured,” said Dr. Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “For the first time, children 12 and older in the United States with genotypes 1 through 6 chronic hepatitis C virus infection now have options of two direct-acting antiviral regimens that offer high cure rates while eliminating the need for interferon injections.”
An open-label clinical trial involving 100 pediatric patients with hepatitis C virus genotype 1 infection, was used to establish the safety and efficacy of Harvoni in this patient population. Twelve weeks after completing treatment with the antiviral, 98 percent of patients in the study showed no detectable virus in the blood. This response to treatment indicated that Harvoni was able to cure infection in these patients, which was a similar result to that observed in clinical trials of adult patients.
Similarly, Solvaldi was tested alongside ribavirin in an open-label trial of 50 pediatric patients. One hundred percent of patients with hepatitis C genotype 2, and 97 percent of patients with genotype 3 had no virus detected in the blood three months after the study.
“These approvals will help change the landscape for hepatitis C virus treatment by addressing an unmet need in children and adolescents,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. Both Harvoni and Sovaldi carry boxed warnings for their risk of reactivating hepatitis B infection in patients concurrently infected with it and hepatitis C.