Effects of Direct-acting Antiviral Agents on HCV Cognitive Function, and Depression in HCV Related Cirrhosis: A Prospective Clinical Trial

Investigations will be performed according to the Declaration of Helsinki and approval of the enrolment as well as the usage of patient blood samples for research purpose will be obtained from the institutional ethics committee, and written informed consent will be obtained from all patients.The primary analysis upon which the sample size consideration was based involved the comparison of the SVR subgroup and the subgroup of patients without SVR. For the sample size calculation, we a two-factorial design (time course × SVR) with the use of a two-way analysis of variance (ANOVA) analysis, a significance level of 5% and a statistical power of at least 80% to detect a medium effect size (d = 0.5) and thus to show a significant group difference. Based on this background, the optimal sample size is calculated to be a total of 102 subjects. To consider asymmetric subgroups and to allow for a moderate dropout rate and additional calculations (secondary study objectives), we aim to include a total of at least 150 study participants in each group with 25 healthy volunteers as controls.

Inclusion criteria

• Age 18-65 years and chronic HCV infection.
• Group A: Patients with hepatitis C (Non-cirrhotic) [n= 150]
• Group B: Patients with hepatitis C related compensated-cirrhosis [n= 150]
• Group C: Healthy volunteers [n= 25]

Exclusion criteria

• Current overt hepatic encephalopathy or during the last 1 month
• TIPS (transjugular intra- hepatic porto-systemic shunt)
• elective surgery planned within the next 8 weeks
• unable to give informed consent
• HIV infection
• chronic respiratory insufficiency
• current infection and receiving antibiotics
• renal failure (serum creatinine ≥ 1.5 mg/l)
• hepatocellular carcinoma,
• patient with other neurological disease
• intake of sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil, neuromuscular blocking agents)