Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents

Corporacion Parc Tauli80 enrolled

Overview

Study about the improvement of cognitive, psychopathological and functional abilities in Hepatitis C Virus (HCV) infected patients after eradication of the virus with direct antiviral agents.

The aim of this study is to investigate the effect that the eradication of the HCV has on cognition, quality of life and psychopathology. At the same time, investigators intend to study the association between cognitive changes and some clinical variables. The sample consists of 80 subjects (40 HCV patients and 40 HCV patients coinfected with the Human Immunodeficiency Virus, HIV). Exclusion criteria: Cirrhosis, presence of minimal hepatic encephalopathy or active drug consumption. A neuropsychological assessment is made before the treatment with direct antiviral agents to evaluate memory, executive functions, processing speed, anxiety, depression and quality of life. Additionally, the following clinical variables are collected: Viral charge, immunosuppression (measured with T Cells CD4 (CD4), CD4 nadir and T Cells CD8 (CD8)) and fibrosis level, HCV genotype and plasma biomarkers: Brain-Derived Neurotrophic Factor (BDNF), Interleukine 6 (IL6), Tumor Necrosis Factor (TNF-a),Glial fibrillary acidic protein (GFAP), Soluble CD14 (SCD14), Neuro-specific enolase (NSE). The second neuropsychological assessment and clinical data collection is carried out after treatment, concretely 6 months after HCV is undetectable in plasma.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HCV Infection HCV Coinfection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients over 18 years old with indication to receive antiviral treatment * Diagnosis of chronic infection by hepatitis C virus in the fibrous phase F3 or F4 that have not presented any clinical decompensation of their liver disease, with or without HIV co-infection Exclusion Criteria: * Active alcohol consumption\> 40g daily or history of chronic alcoholism * Active consumption of other toxics (heroin, cocaine, cannabis) * Patients with minimum hepatic encephalopathy * Background of cerebral neurological disease, chronic renal insufficiency and / or psychiatric illnesses assessed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, which can affect cognitive functions. * Active use of psychotropics or benzodiazepines

Outcomes

Primary Outcomes

Memory tests

Rey Auditory Verbal Learning Test (RVLT, Spreen \& Strauss 1998) assesses verbal learning, recall and recognition memory; Wechsler Adults Intelligence Scale III backward digits subtest (WAIS, Wechsler 1997) assesses working memory. All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single memory component.

Time frame: baseline, change at 6 months after treatment

Attention tests

Continous Performance Test (CPT, Conners 2000) assesses sustained attention, inattentiveness and impulsivity; WAIS forward digits subtest (WAIS III, Wechsler 1997) assesses attention. All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single attention component.

Time frame: baseline, change at 6 months after treatment

Executive function tests

Stroop Test (Stroop, 1935) assesses flexibility and inhibition of automatic responses; Trail Making Test (TMTA-B Reitan, 1993) assesses visual tracking and flexibility, phonetic and semantic fluency tests (Lezak, 1995) assess verbal fluency; Tower of London (Culbertson \& Zillmer, 2005) assesses visual reasoning and planification. All direct scores have been transformed into T-scores (mean=50; SD=10), which allows to obtain a single executive function component.

Time frame: baseline, change at 6 months after treatment

Speed processing test

Digit symbol test (WAIS III, Wechsler 1997) assesses visuomotor speed. The direct scores have been transformed into T-scores (mean=50; SD=10).

Time frame: baseline, change at 6 months after treatment

Secondary Outcomes

Hospital Anxiety and Depression Scale (HADS)

It is a self-registering scale of 14 items: 7 items evaluating anxiety and 7 items evaluating depression (Zigmond \& Snaith, 1983). Scoring range: 0-21 for each subscale. Scores \>10 in each subscale imply a significant anxious/depressive symptomatology.

Data from ClinicalTrials.gov

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