The purpose of this study is to examine whether neurocognitive impairments experienced by patients with chronic hepatitis C virus (HCV) infection can be reversed by treating HCV, with a new combination of direct acting antiviral drugs (daclatasvir (DCV), asunaprevir (ASV) and beclabuvir (BCV)). The study will assess the effect of HCV on the central nervous system (CNS) by assessing neurocognitive function and brain injury prior to treatment, and comparing it to the end of treatment, and 4, 12 and 24 weeks after treatment.
This study will evaluate the effect of DCV/ASV/BCV on neurocognitive functioning and brain metabolite concentrations in the frontal white matter and the basal ganglia in people with chronic HCV genotype 1 infection, through a comparison of baseline and post-treatment parameters. This is an open label single arm multi-centre study. All participants will each receive daclatasvir (30mg), asunaprevir (200mg) and beclabuvir (75mg) in a fixed-dose combination oral tablet for twice daily administration with food. Duration of treatment will be 12 weeks for all subjects followed by 24 weeks of observational follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Each participant will each receive daclatasvir (30mg), asunaprevir (200mg) and beclabuvir (75mg) in a fixed-dose combination oral tablet for twice daily administration with food.
St Vincent's Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Neurocognitive functioning
Mean change in neurocognitive functioning (global z-score representing overall neurocognitive performance across CogState, pegboard and colours trails)
Time frame: 36 weeks
Brain metabolite concentrations
Mean change in five absolute metabolite concentrations (NAA,Cho, Cr, mlo, glx)
Time frame: 36 weeks
Neurocognitive functioning
Mean change in neurocognitive functioning (global z-score representing overall neurocognitive performance across CogState, pegboard and colours trails)
Time frame: 12 and 24 weeks
NAA metabolite concentration in the brain
Time frame: 12 and 24 weeks
Cho metabolite concentration in the brain
Time frame: 12 and 24 weeks
Cr metabolite concentration in the brain
Time frame: 12 and 24 weeks
MLO metabolite concentration in the brain
Time frame: 12 and 24 weeks
Glx metabolite concentration in the brain
Time frame: 12 and 24 weeks
Change in neurocognitive functioning compared between subjects with and without sustained virological response (SVR)
Mean change in neurocognitive functioning (global z-score representing overall neurocognitive performance across CogState, pegboard and colours trails)
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Time frame: 24 weeks
Change in brain metabolite concentrations compared between subjects with and without sustained virological response (SVR)
Mean change in absolute metabolite concentrations (NAA,Cho, Cr, mlo, glx)
Time frame: 24 weeks