Clinical trial NCT00863109: Quality of Life During Treatment of Chronic Hepatitis C (P05278/MK-4031-336)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Genotype 1
HCV-1
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Chronic Hepatitis C, Genotype 1, no other co-infection and compensated liver disease who receive PEG and RBV in combination therapy according to standard clinical practice.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with chronic hepatitis C (CHC)
* Participants with HCV genotype 1
* Participants who, at the time of the study, are referred to the Hospital Pharmacy Service to begin treatment with PEG and RBV for 48 weeks
* Available to understand and to give Informed Consent

Exclusion Criteria:

- Participants co-infected with Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)

Primary outcomes:
measure: Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores
timeFrame: Baseline, Week 72
measure: Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)
timeFrame: Baseline, Week 72
Secondary outcomes:
measure: Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)
timeFrame: Baseline, Week 72
measure: Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)
timeFrame: Baseline, Week 72
measure: Minimal Clinically Important Difference (MCID) in SF-36 Scores
timeFrame: From Baseline Visit to Final Visit (up to 72 weeks)
measure: MCID in CLDQ-HCV Scores
timeFrame: From Baseline Visit to Final Visit (up to 72 weeks)
measure: Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)
timeFrame: From Baseline Visit to Final Visit (up to 72 weeks)
Other outcomes:
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