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Harvoni shows safety, efficacy in younger pediatric population
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AMSTERDAM — A fixed, half-dose combination of Harvoni was associated with sustained virologic response rates of 99% or greater in a cohort of children aged 6 to 11 years, according to data presented at the International Liver Congress.
“This regimen represents a highly effective and well-tolerated treatment option for children aged 6 to 11,” Karen F. Murray, MD, of the departments of gastroenterology, hepatology, and transplantation at Seattle Children’s Hospital, said during a press conference.
Murray and colleagues assigned 90 children to receive a modified dose of Harvoni (ledipasvir/sofosbuvir, Gilead Sciences). “The half-strength tablet was formulated as a combination for this study. Ledipasvir/sofosbuvir for children under the age of 12 is not yet approved,” she said. “This is entirely investigational.”
Eighty-seven of the children were treated for 12 weeks. One patient with cirrhosis and treatment experience and two patients with genotype 3 disease and treatment experience were treated for 24 weeks. The first 12 patients in the study were analyzed for pharmacokinetics.
Treatment for 12 weeks yielded an SVR12 rate of 99%, while the rate for 24 weeks of therapy was 100%. The rate was 100% for two patients treated with ledipasvir/sofosbuvir plus ribavirin.
While there were no grade 3 or 4 adverse events, 70% of patients in the 12-week group experienced some adverse event as did 100% of the patients treated for 24 weeks.
Laboratory abnormalities occurred in 5% of patients treated for 12 weeks.
The open-label study was conducted at 31 sites in Australia, New Zealand, the U.K. and the U.S. Murray said that the rate of HCV in children may be as high as 0.4% in Europe and the U.S. and as high as 6% in some resource-limited countries. – by Rob Volansky
Reference:
Murray KS, et al. Abstract #PS-101. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam.
Disclosure: Murray reports receiving grant support from Gilead and being a stockholder with Merck.