Clinical trial NCT03508115: Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents
Official title: Changes in Cognition in HCV Patients After Virus Eradication With Direct Antiviral Agents. Relationship With Clinical and Sociodemographic Variables
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCV Infection
HCV Coinfection
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCV patients who are candidates to direct antiviral treatment

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Memory tests
timeFrame: baseline, change at 6 months after treatment
measure: Attention tests
timeFrame: baseline, change at 6 months after treatment
measure: Executive function tests
timeFrame: baseline, change at 6 months after treatment
measure: Speed processing test
timeFrame: baseline, change at 6 months after treatment
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline, change at 6 months after treatment
measure: 36-Item Short Form Health Survey (SF-36 )
timeFrame: baseline, change at 6 months after treatment
measure: Fibroscan
timeFrame: Baseline, change at 6 months after treatment
measure: HCV RNA
timeFrame: Baseline, change at 3 months after treatment, change at 6 months after treatment.
measure: Immunosuppression state
timeFrame: Baseline
Other outcomes:
measure: Blood Biomarkers measures
timeFrame: 1 day pretreatment and change at 6 months post treatment
Locations:
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