M15-684 AbbVie 3DAA Regimen in HCV GT1b (GARNET)
Research type
Research Study
Full title
An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)
IRAS ID
189741
Contact name
Stephen Ryder
Contact email
Sponsor organisation
AbbVie Deutschland Gmbh & Co KG
Eudract number
2015-003370-33
Duration of Study in the UK
0 years, 10 months, 11 days
Research summary
Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer, and patients may then need a liver transplant.
Treatment options for HCV infection are limited for patients. Drug companies are developing drugs called ‘Direct Acting Antiviral Agents’ (DAAs) which work by targeting the different stages of the virus lifecycle. DAAs provide an alternative option to injectable therapies for patients with HCV and are generally well tolerated.
The 3-DAA regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir has already been approved for the treatment of genotype 1 chronic HCV infection over a 12 week treatment period. Patients with HCV genotype 1b infection in particular have consistently shown a high response rate to the 3-DAA regimen. As a result, further research will be conducted to explore whether the 3-DAA treatment duration can be shortened in this group to 8 weeks, which might reduce the drug exposure and overall healthcare costs.
This study will test the safety and effectiveness of ombitasvir/paritaprevir/ritonavir and dasabuvir over an 8 week treatment course in treatment naïve (those who have received no previous treatment for their HCV) adults with HCV genotype 1b infection, without cirrhosis.
Approximately 160 subjects will be included from approximately 20 sites in 8 participating countries. Subjects will attend regular study visits at clinics during the course of the study. Participation in this study will last approximately 37 weeks including a screening period of up to 35 days. Subjects will receive study medication for 8 weeks then follow up for 24 weeks. Safety and efficacy evaluations will occur throughout the study.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/1692
Date of REC Opinion
30 Nov 2015
REC opinion
Further Information Favourable Opinion