Hepatitis C, Chronic Clinical Trial
Official title:
Evaluation of the Health-Related Quality of Life During Combined Treatment of Chronic Hepatitis Due to Hepatitis C Virus Under Habitual Clinical Practise Conditions.
The primary objective of this study is to evaluate the impact of chronic hepatitis C (CHC), and the treatment thereof with peginterferon alpha-2b (PEG) and ribavirin (RBV) according to standard clinical practice, on the health-related quality of life (HRQL) of a cohort of participants throughout 72 weeks of follow-up. HRQL was assessed using the 36-Item Short-Form Health Survey (SF-36) and the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV).
As widely shown in previous reports Hepatitis C Virus (HCV) patients commonly experience
fatigue, anxiety, and depression. These symptoms negatively affect patients' functional
health, ability to work, self-perceived health, HRQL and well-being. Psychosocial issues and
reduced HRQL are frequently experienced by HCV patients. HCV patients have more HRQL
impairment than the general population. There is some evidence that HCV patients who
experience greater fatigue, greater psychiatric symptoms, and poorer HRQL are more likely to
discontinue treatment prematurely, with a negative impact on virological response. In
addition to well-known side effects of interferon, one important determinant of HRQL during
anti-viral therapy for HCV is development of RBV-induced anemia. Treatment of anemia
improves HRQL, potentially impacting adherence to antiviral regimen and improving virologic
response. These issues emphasize the importance of investigating the physical and
psychosocial experiences and HRQL of HCV patients.
The sample size of the study must allow evaluating HRQL of HCV patients based on the SF-36
before PEG treatment and at each of the following study visits.
To be able to detect differences of or over 4.2 points in the vitality dimension between the
basal visit and following visits, estimating a standard deviation of 22 points, a
statistical power of 80%, and a level of significance of 0.05, 216 patients will be needed.
Considering a loss of follow up of 15%, a total of 238 patients are planned for this study.
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Observational Model: Cohort, Time Perspective: Prospective
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