FDA Approves Supplemental Indications for Gilead Science Hepatitis Drugs Harvoni and Sovaldi To Treat Pediatric Patients

Earlier today, Gilead Sciences, Inc announced that the United States Food and Drug Administration (US FDA) has approved supplemental indications for the Hepatitis drugs Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi (sofosbuvir 400 mg) tablets. These drugs are aimed at treating chronic hepatitis C (HCV) infection in adolescents who do not have cirrhosis or who have compensated cirrhosis and are at least 12 years of age or weigh at least 35kg.

Hepatitis literally means “swollen liver,” so the HCV (virus) is a condition that causes inflammation and eventually liver failure.

More specifically, Harvonio has been approved for pediatric patietns who have genotype 1, 4, 5 or 6 chronic HCV infection; Sovaldi has been approved to treat pediatric patients who have genotype 2 or 3 chronic HCV infection, to be used in combination with another drug, ribavirin. It is estimated there are between 23,000 and 46,000 pediatric HCV patients at any given time in the United States, and many of these adolescent patients were infected with HCV at birth.

Of course, both of these drugs—Harvoni and Sovaldi—have already been approved to treat adult HCV patients.

University of Washington School of Medicine professor of pediatrics, Karen Murray, MD, comments, “The approvals of Sovaldi and Harvoni for pediatric patients will enable adolescents to finally benefit from interferon-free treatment for HCV infection.” Also with Seattle Children’s Hospital, Dr. Murray continues, “These therapies address a significant unmet medical need and represent an important advance for HCV-infected adolescents.”

Furthermore, Gilead Sciences Chief Scientific Officer and Executive Vice President of Research and Development, Norbert Bischofberger, PhD comments, “Gilead’s goal is to develop and deliver treatments that provide all patients with HCV the potential to be cured. For the first time, children 12 and older in the United States with genotypes 1 through 6 chronic HCV infection now have options of two direct-acting antiviral regimens that offer high cure rates while eliminating the need for interferon injections.”

Notably, children who are born to infected mothers are at an increased risk of contracting the infection, too. As such, the FDA estimates between 23,000 and 46,000 children in the United States could have hepatitis C. Overall, the United States Centers for Disease Control and Prevention estimates that somewhere between 3 and 4 million people, in the US, have the virus.