Neurocognitive Performance and Emotional State in HCV Patients With IFN-free Antiviral Therapy

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The present study evaluates neurocognitive performance as well as measures of mood, quality of life, and fatigue in patients with chronic hepatitis C infection. In a prospective longitudinal study design, included patients are monitored before, during, and in the long-term follow-up of interferon-free antiviral treatment (Sofosbuvir +/-Daclatasvir +/- Ribavirin or Sofosbuvir/Ledipasvir +/- Ribavirin). Main study goals are to compare post therapy results of sustained virologic responders to corresponding pretreatment values as well as to historic interferon-treatment patients without virological response. It is expected that HCV-associated neuropsychiatric symptoms and neurocognitive impairment is - at least in part - reversible by the successful application of modern IFN-free antiviral medication.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wuerzburg
• Treatments: Antiviral Agents; Ledipasvir; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Patients with chronic hepatitis C and indication for interferon-free antiviral therapy.

• Written informed consent to study participation, especially to long-term follow-up monitoring of quality of life, emotional state, fatigue, and neurocognitive performance after antiviral treatment.

• Age of study participants: between 18 and 75 years.

• At study entry, all participating patients need to have documented antibodies to HCV and circulating HCV-RNA as measured by reverse-transcription polymerase chain reaction (Cobas Amplicor HCV MonitorTM 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).

• Age under 18 years or over 75 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 DSM-IV criteria), psychosis, active intravenous drug use or alcohol abuse.