M14-730 DAA treatment for HCV/HIV Co-infection
Research type
Research Study
Full title
A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 – 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2)
IRAS ID
202362
Contact name
Chloe Orkin
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2015-005577-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 12 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.
Patients who have both HCV and Human Immunodeficiency Virus (HIV) are faced with a bigger chance of developing progressive liver disease and death.
AbbVie is currently developing 2 "next generation" direct acting antiviral agents (DAAs) which work by targeting the different stages of the Hepatitis C virus lifecycle.
According to data from different clinical trials, the effectiveness of DAA therapy appears to be similar between patients with HCV infection on its own, and patients with both HCV and HIV (co-infection).
This study will test the safety and effectiveness of ABT-493 and ABT-530 over an 8 or 12 week treatment course, in subjects without or with cirrhosis, who have both HIV and HCV infection.
Approximately 150 subjects will be included across approximately 39 sites worldwide. Subjects will attend regular study visits at clinics during the course of the study. Participation in this study will last up to approximately 41 weeks. Subjects will receive study medication for 8 or 12 weeks (depending on their treatment arm) then follow up for 24 weeks. Safety and efficacy evaluations will occur throughout the study.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1060
Date of REC Opinion
12 Jul 2016
REC opinion
Further Information Favourable Opinion