Phase 2 of SOF/VEL/VOX FDC in Children with HCV
Research type
Research Study
Full title
A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed Dose Combination in Adolescents and Children with Chronic HCV Infection
IRAS ID
252591
Contact name
Deirdre Kelly
Contact email
Sponsor organisation
Gilead Sciences Inc.
Eudract number
2018-000480-87
Duration of Study in the UK
3 years, 8 months, 8 days
Research summary
Hepatitis C is an infectious disease, caused by the hepatitis C virus (HCV) that primarily affects the liver. A virus is a small organism that attaches itself to healthy cells and forces them to make more of the virus. 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.
Data on HCV in children is limited, but there is estimated around 5 to 6.6 million infections in children 15 years of age or younger. 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 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 under the age of 12 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/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) tablet in adults for 8 weeks have demonstrated high cure rates (sustained viral response) with excellent tolerability and efficacy.
This study addresses the question of whether SOF/VEL/VOX FDC treatment for 8 weeks will allow adolescent and paediatric patients with HCV infection to be treated successfully with an oral therapy. The study treatment will be for 8 or 12 weeks depending on the participants previous treatment with other direct acting antivirals and cirrhosis status of the patient.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0330
Date of REC Opinion
4 Jan 2019
REC opinion
Further Information Favourable Opinion