Sofosbuvir/Ribavirin in Adolescents and Children
Research type
Research Study
Full title
A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children with Genotype 2 or 3 Chronic HCV Infection
IRAS ID
163112
Contact name
Deirdre Kelly
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2014-002283-32
Duration of Study in the UK
3 years, 2 months, 30 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 to 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 Sofosbuvir (SOF) in adults have demonstrated high cure rates (sustained viral response) with excellent tolerability and efficacy. Adult studies have also shown that the use of SOF with RBV would provide a shorter, all oral and more tolerable treatment option.
This study addresses the question of whether sofosbuvir plus ribavirin will allow paediatric patients with genotypes 2 and 3 HCV infection to be treated successfully with an all oral therapy.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1185
Date of REC Opinion
27 Nov 2014
REC opinion
Further Information Favourable Opinion