Long-Term Evaluation Follow-up of Neurocognitive Performance and Emotional State in Patients With Chronic Hepatitis C Infection and a Former (Peg)Interferon Alfa-2b-Based Therapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatitis C, Chronic
- Sponsor
- University of Wuerzburg
- Enrollment
- 197
- Locations
- 1
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy.
M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen
Questions:
- Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment?
- At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication?
- At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life?
- In the absence of clinically significant liver damage in patients with chronic hepatitis C - does the mere presence of the hepatitis C virus have any significant influence on neurocognitive or attentional performance?
- Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, emotional state and - above all - is neurocognitive performance significantly improved even in the absence of severe liver damage?
Detailed Description
This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy. M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen Questions: * Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment? * At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication? * At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life? * Can the results of the current and previous studies be confirmed by alternative / additional psychometric instruments in specified subsample? (Fatigue Impact Scale; FIS-D, SF-36) * In the absence of clinically significant liver damage in patients with chronic hepatitis C - does the mere presence of the hepatitis C virus have any significant influence on neurocognitive or attentional performance? * Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, is emotional state and - above all - neurocognitive performance significantly improved even in the absence of severe liver damage? Methods: * Multifactorial analysis of test results: pre- vs. post-therapy; sustained virological response vs. nonresponse/relapse. * Psychometric evaluation instruments / psychometric questionnaires (HADS-D, SCL-90-R, Subsample : SF-36, FIS-D) * Evaluation of neurocognitive performance by the Test battery of Attentional Performance (TAP) * Evaluation in a prospective, longitudinal study design. Planned sample size / sample size considerations * N = 150 patients (hepatitis C patients in a longitudinal study design: t1\[before onset of interferon therapy\] ... t5\[at least 12 months after the end of antiviral treatment\] Power calculations / power considerations: * Given: 2-factorial design (time course x SVR); type I error = 0.050; type II error = 0.20 (power = 0.80) - as usually assumed in clinical trials. * With respect to the independent factor SVR ("sustained virological response", 2 factor levels), optimum / optimal sample sizes range from 42 (large effect size d = 0.8) to 102 (medium effect size d = 0.5). Smaller effect sizes - according to previous work in this field - do not appear to bear any clinical relevance. * (Pairwise comparisons of dependent samples \[e.g. pre- vs. post-therapy or pre-therapy vs. long-term follow-up\] require even smaller optimal sample sizes ranging from 16 to 43 for large or medium effect sizes.) Patient recruitment: * Patients with chronic hepatitis C infection and therapy with (peg)interferon alfa-2b. * Patients with informed written consent (with respect) to a long-term follow-up of psychiatric side effects and neurocognitive performance. * Patients with baseline monitoring of neuropsychiatric symptoms and neurocognitive performance.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with chronic hepatitis C and indication for interferon-based antiviral therapy.
- •Written informed consent to study participation, especially to long-term follow-up monitoring of psychiatric and neurocognitive side effects of combination therapy with (peg)interferon alfa-2b and ribavirin.
- •Age of study participants: between 18 and 65 years.
- •All patients need to have documented antibodies to hepatitis C virus (HCV) and circulating HCV-RNA as measured by reverse-transcription polymerase chain reaction (Cobas Amplicor HCV Monitor™ test, Roche Diagnostics)
Exclusion Criteria
- •Insufficient knowledge of the German language or cognitive impairment (due to the indispensable application of questionnaires and the TAP, test battery of attentional performance).
- •Further Exclusion Criteria:
- •Age under 18 years or over 65 years
- •Coinfections such as hepatitis B virus or human immunodeficiency virus
- •Severe internal diseases (e.g., cancer, ischemic heart disease, autoimmune disease)
- •Major depressive disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition \[DSM-IV\] criteria), psychosis, active intravenous drug use or alcohol abuse.
- •These additional exclusion criteria are important in order to avoid interfering or confounding effects by other variables that are not linked to the hepatitis C infection.
Outcomes
Primary Outcomes
Not specified