Phase 2 - Sofosbuvir/Velpatasvir for Chronic HCV Infection
Research type
Research Study
Full title
A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children with Chronic HCV Infection
IRAS ID
215506
Contact name
Sanjay Bansal
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2016-002446-23
Duration of Study in the UK
3 years, 0 months, 1 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 (genetic variants) of HCV. Chronic infection in adults causes liver cirrhosis (scarring) 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 (Peg-IFN) and Ribavirin (RBV) tablets however treatment is over a long period and results in very significant side effects thus are not very well tolerated.
Studies of Sofosbuvir/Velpatasvir (SOF/VEL) 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/VEL would provide a shorter, all oral and more tolerable treatment option than those treatments involving RBV.
This study evaluates the pharmacokinetics (what happens to the medicine in the body?), safety, and antiviral activity of SOF/VEL in children with chronic HCV-infections. The adult clinical doses (400 mg /100 mg) will be evaluated in adolescents (12 to <18 years old). Age-appropriate formulations of SOF/VEL FDC (a smaller tablet and a non-tablet formulation currently under development) that offer an important option in the treatment of HCV-infection in the paediatric population are planned for evaluation in children below 12 years of age or children who are unable to swallow the adult dose tablet formulation.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/2026
Date of REC Opinion
19 Jan 2017
REC opinion
Further Information Favourable Opinion