Evaluation of Quality of Life, Neurocognitive Performance, Fatigue, and Emotional State in HCV Patients Before, During, and in the (Long-term) Follow-up of an IFN-free Antiviral Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Neurocognitive Performance (computerized TAP - Test Battery for Attentional Performance)
研究概览
简要总结
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.
详细描述
Chronic hepatitis C is one of the most frequent infectious diseases worldwide and a major cause of chronic liver disease. At diagnosis, approximately 20 % of patients with chronic hepatitis C already have liver cirrhosis.
Therapy for hepatitis C has meanwhile reached a high level of efficacy and effectiveness: at present, about 90 % of patients treated with a combination of peginterferon alfa, ribavirin and sofosbuvir for up to 12 weeks will reach a sustained loss of hepatitis C virus.
Psychiatric side effects of interferon alfa are well known and may require dose reduction or even premature discontinuation of therapy.
As patients on interferon treatment sometimes report concentration or memory impairment that in some cases interferes considerably with their capacity to manage the requirements of everyday life, the investigators planned and intend to conduct a prospective and longitudinal study evaluating - among other parameters - neurocognitive performance before, during, and after therapy with an antiviral IFN-free therapy.
In previously performed scientific work, the investigators were able to show that interferon-based combination therapy of chronic hepatitis C may cause reversible impairment of neurocognitive performance during treatment period. Moreover, the investigators have recently demonstrated that successful IFN-based antiviral treatment (criterion: SVR, sustained virological response) leads to significant improvement of relevant aspects of attentional and neurocognitive performance. These results indicate that HCV-related neurocognitive impairment is potentially reversible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
IFN-free antiviral treatment
Combination #1 or Combination #2 or Combination #3 or Combination #4 or Combination #5
干预措施: Combination #5 (Drug)
IFN-free antiviral treatment
Combination #1 or Combination #2 or Combination #3 or Combination #4 or Combination #5
干预措施: Combination #1 (Drug)
IFN-free antiviral treatment
Combination #1 or Combination #2 or Combination #3 or Combination #4 or Combination #5
干预措施: Combination #2 (Drug)
IFN-free antiviral treatment
Combination #1 or Combination #2 or Combination #3 or Combination #4 or Combination #5
干预措施: Combination #3 (Drug)
IFN-free antiviral treatment
Combination #1 or Combination #2 or Combination #3 or Combination #4 or Combination #5
干预措施: Combination #4 (Drug)
结局指标
主要结局
Change in Neurocognitive Performance (computerized TAP - Test Battery for Attentional Performance)
时间窗: evaluation time points are at baseline, after 4 weeks and 12 weeks of antiviral IFN-free treatment, four weeks and 12 months after the end of antiviral IFN-free therapy
assessment of changes over treatment time (repeated measures design)
次要结局
- Change in Fatigue (Fatigue Impact Scale - FIS-D, questionnaire)(evaluation time points are at baseline, after 4 weeks and 12 weeks of antiviral IFN-free treatment, four weeks and 12 months after the end of antiviral IFN-free therapy)
- Change in Health-Related Quality of Life (SF-36, questionnaire)(evaluation time points are at baseline, after 4 weeks and 12 weeks of antiviral IFN-free treatment, four weeks and 12 months after the end of antiviral IFN-free therapy)
- Change in Emotional State (Hospital Anxiety and Depression Scale HADS, questionnaire)(evaluation time points are at baseline, after 4 weeks and 12 weeks of antiviral IFN-free treatment, four weeks and 12 months after the end of antiviral IFN-free therapy)
研究者
Arne Schaefer
PD Dr. Arne Schaefer
University of Wuerzburg
