NCT00863109

Quality of Life During Treatment of Chronic Hepatitis C (P05278/MK-4031-336)

Evaluation of the Health-Related Quality of Life During Combined Treatment of Chronic Hepatitis Due to Hepatitis C Virus Under Habitual Clinical Practise Conditions.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 133 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic
• Genotype 1
• HCV-1

Interventions

Type	Name	Description
BIOLOGICAL	Peginterferon alfa-2b (PEG)	Pegylated interferon alfa-2b was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).
DRUG	Ribavirin (RBV)	Ribavirin was administered in accordance with the dosage and pattern prescribed by each participant's physician (standard clinical practice).

Timeline

• Start date: 2009-04-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2009-03-17
• Last updated: 2017-04-07
• Results posted: 2014-06-12