Harvoni in Adolescents and Children with HCV
Research type
Research Study
Full title
A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/ Sofosbuvir Fixed Dose Combination ± RBV in Adolescents and Children with Chronic HCV-Infection
IRAS ID
165854
Contact name
Sanjay Bansal
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2014-003578-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 6 days
Research summary
Hepatitis C is an infectious disease, caused by the hepatitis C virus (HCV) that primarily affects the liver. There are 6 main genotypes of HCV. Chronic infection in adults causes liver cirrhosis which leads onto liver failure or liver cancer. Liver transplant is then required. Only 20% of children show symptoms of HCV and the need for liver transplant is rare, however they may go on to develop liver disease 10 years after onset of infection. Because of the lack of symptoms in children, the European Society for Paediatric Gastroenterology, Hepatology and Nutrition guidelines suggest that the primary goal of treating children with HCV should be to eradicate the infection completely. The current standard of care for children over the age of 3 is weekly injections of Pegylated Interferon and Ribavirin (RBV) tablets however treatment is over a long period and results in very significant side effects thus not very well tolerated.
Studies of Ledipasvir/Sofosbuvir Fixed Dose Combination (LDV/SOF FDC) in adults have demonstrated high cure rates (sustained viral response) with excellent tolerability and efficacy in patients with HCV genotypes 1, 3 and 4. Data is not yet available for other genotypes.
Adult studies have also shown that the use of LDV/SOF FDC would provide a shorter, all oral and more tolerable treatment option than those treatments involving RBV.
This study addresses the question of whether a SOF/LDV fixed dose tablet (with or without ribavirin) will allow paediatric patients with genotype 1, 3 and 4 HCV infection to be treated successfully with an all oral therapy. If emerging LDV/SOF FDC data in genotypes 2, 5, and 6 support treatment in these genotypes in adults, paediatric subjects with genotype 2, 5 and 6 will be enrolled in the current study.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/0278
Date of REC Opinion
17 Feb 2015
REC opinion
Favourable Opinion