Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Harvoni, Sovaldi Granted Pediatric Hepatitis C Indications

By Ryan Bushey | April 10, 2017

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.


Filed Under: Drug Discovery

 

Related Articles Read More >

EVEREST lead investigator on why Dupixent sets a new bar for treating coexisting CRSwNP and asthma
Sanders, King target DTC pharma ads but the industry worries more about threats to its $2B R&D model
Zoliflodacin wins FDA nod for treatment of gonorrhea
FDA approved ENFLONSIA for the prevention of RSV in Infants
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE