Harvoni, Sovaldi Granted Pediatric Hepatitis C Indications

The Food and Drug Administration (FDA) on Friday approved new supplemental indications for Gilead Sciences’s notable hepatitis C (HCV) drugs.

Harvoni and Sovaldi gained approval for chronic HCV infections in pediatric patients 12 years of age or older, according to the announcement. The former is approved for patients with the 1,4,5, or 6 chronic HCV genotype whereas the latter is approved for patients with either 2 or 3 genotype in combination with ribavirin.

“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, M.D., the professor of pediatrics at the University of Washington School of Medicine and Seattle Children’s, in a statement. “These therapies address a significant unmet medical need and represent an important advance for HCV-infected adolescents.”

The Foster City, California-based biotech’s announcement said there are an estimated 23,000-46,000 pediatric HCV patients in the United States where most of whom were infected with the virus at birth.

The FDA made the decision based on the results from two open label-clinical trials.

A study with Harvoni evaluated 12 weeks of once-daily treatment with genotype 1 treatment naïve and treatment experienced HCV-infected adolescents who were 12 years of age and older with cirrhosis or without cirrhosis. The treatment regimen produced a sustained viral response rate of 98 percent where none of the subjects experienced a virologic failure or relapse.

The other analysis evaluated 12 to 24 weeks of treatment with Sovaldi in combination with weight-based ribavirin in HCV genotype 2 or 3 patients in a similar age group. It was able to produce sustained viral response rate of 100 percent for genotype 2 group while it reached 97 percent for genotype 3.

“Gilead’s goal is to develop and deliver treatments that provide all patients with HCV the potential to be cured,” said Gilead’s Vice President of Research and Development and Chief Scientific Officer Norbert Bischofberger, Ph.D., in a statement. “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.”

These drugs gaining the ability to serve another patient population could help Gilead’s sales prospects as competition from rival firms like AbbVie and Merck chip away at its control over the lucrative hepatitis C market.