N/A
N=46
HCV and Co-morbid Alcohol Use Disorders: A Translational Investigation of Antiviral Therapy Outcomes on CNS Function
Hepatitis C · Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03902366 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Changes in Neuropsychological Assessment Battery (NAB) Attention Module Scores — 10.99; 0.31; 6.35 Units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Neuropsychological assessment (Diagnostic_test); Neuroimaging (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Neuropsychological Assessment Battery (NAB) Attention Module Scores |
10.99; 0.31; 6.35 | — |
| PRIMARY Changes in Neuropsychological Assessment Battery (NAB) Memory Module Scores |
9.07; 1.95; 3.50 | — |
| PRIMARY Changes in Neuropsychological Assessment Battery (NAB) Executive Functions Module Scores |
10.65; 5.46; 18.00 | — |
| PRIMARY Changes in Alcohol Use Measured Using the Timeline Follow Back (TLFB) |
3.78; 44.00; -6.25 | — |
| PRIMARY Change in Behavior as Assessed by the Balloon Analogue Risk Task (BART) |
-0.018; -0.005; -0.014 | — |
| PRIMARY Change in Behavior as Assessed by the Monetary Incentive Delay (MID) Task |
-0.39; 12.77; 3.63 | — |
| PRIMARY Change in Fatigue Severity Scale (FSS) Score |
4.87; 2.46; 4.80 | — |
| PRIMARY Change in Beck Depression Inventory Second Edition (BDI-II) Score |
2.48; 1.92; -0.60 | — |
| PRIMARY Change in Fractional Anisotropy (FA) in White Matter Tracts |
0.416; -0.612; -1.953; 0.297; -0.768; -1.189 | — |
| PRIMARY Change in Mean Diffusivity (MD) in White Matter Tracts |
-0.740; 0.490; 0.159; -0.827; 0.358; 0.393 | — |
| PRIMARY Changes in Inflammatory Profile Markers: Neutrophil to Lymphocyte Ratio (NLR) and Monocyte to Lymphocyte Ratio (MLR) |
-0.36; 0.17; -0.50; -0.03; 0.03; 0.45 | — |
Summary
The primary objective of this research project is to compare neuropsychiatric functioning, cortical activity, white matter integrity, and immune response among Veterans with and without alcohol use disorder (AUD), before and after direct-acting antiviral (DAA) therapy [a new treatment for chronic infection with the hepatitis C virus (HCV)]. Demographically-matched comparison groups of Veterans without HCV (HCV-, with and without AUD) will similarly be evaluated to determine the relative contribution of HCV and an HCV "cure" to outcomes putatively affected by alcohol abuse.
Two specific aims are proposed.
Aim 1: Determine the impact of DAA therapy and a sustained viral response on central nervous system (CNS) function.
Aim 2: Evaluate the effects of AUD and unhealthy alcohol drinking on DAA therapy outcomes and CNS function.
The information learned will address a critical gap in knowledge concerning the effects of alcohol use on DAA therapy outcomes and will help inform treatment guidelines that could be translated to clinical practice, such as targeted interventions to treat AUD in conjunction with HCV infection and follow-up strategies for patients who successfully complete DAA therapy but then need care for other potential CNS-related outcomes.
Eligibility Criteria
Inclusion Criteria
- Adult Veteran (>21 years)
- Able to provide informed consent.
Exclusion Criteria
- Current substance use disorder other than alcohol (except nicotine or caffeine)
- Medical conditions likely to impact immunological function or central nervous system function (such as HIV, cancer, lupus, stroke, neurodegenerative disease, hepatic encephalopathy, multiple sclerosis, or a traumatic brain injury)
- Visible intoxication or impaired capacity to understand study risks and benefits or otherwise provide informed consent
- Past or present schizophrenia, schizoaffective disorder, or current psychosis or mania
- Visual or auditory impairments that would prevent valid neuropsychiatric testing
- Contraindications to MRI (such as surgical aneurysm clips, pacemaker, prosthetic heart valve, neuro-stimulator, implanted pumps, cochlear implants, metal rods, plates or screws, previous surgery, hearing aids, history of welding, metal shrapnel)
Data sourced from ClinicalTrials.gov (NCT03902366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.