Abstract
BackgroundChronic hepatitis C (CHC) and its treatment are associated with a variety of patient-reported symptoms and impacts. Some CHC symptoms and impacts may be difficult to evaluate through objective clinical testing, and more easily measured through patient self-report. This literature review identified concepts raised by CHC patients related to symptoms, impacts, and treatment effects, and evaluated integration of these concepts within patient-reported outcome (PRO) measures. The goal of this work was to provide recommendations for incorporation of PRO measurement of concepts that are relevant to the CHC experience into CHC clinical trial design.MethodsA three-tiered literature search was conducted. This included searches on concepts of importance, PRO measures used in clinical trials, and existing PRO measures. The PRO Concept Search focused on reviewing issues raised by CHC patients about CHC symptoms, disease impact, and treatment effects. The CHC Trials with PRO Endpoints Search reviewed clinical trials with PRO endpoints to assess differences between treatments over time. The PRO Measure Search reviewed existing PRO measures associated with the concepts of interest.ResultsThis multi-tiered approach identified five key concepts of interest: depression/anxiety, fatigue, flu-like symptoms, cognitive function, insomnia. Comparing these five concepts of interest to the PRO measures in published CHC clinical trials showed that, while treatment of CHC may decrease health-related quality of life in a number of mental and physical domains, the PRO measures that were utilized in published clinical trials inadequately covered the concepts of interest. Further review of 18 existing PRO measures of the concepts of interest showed only four of the 18 were validated in CHC populations.ConclusionsThis review identified several gaps in the literature regarding assessment of symptoms and outcomes reported as important by CHC patients. Further research is needed to ensure that CHC clinical trials evaluate concepts that are important to patients and include measures that have evidence supporting content validity, reliability, construct validity, and responsiveness.
Highlights
Chronic hepatitis C (CHC) and its treatment are associated with a variety of patient-reported symptoms and impacts
Results from the CHC patient-reported outcome (PRO) Concept Search and the CHC Trials with PRO Endpoints Search guided the PRO Measure Search, supplemented by findings from PubMed, EMBASE, PROQOLID, and previous research completed in CHC by the authors
PRO data must have been reported in a manner that allowed for determination of differentiation between treatments over time
Summary
Chronic hepatitis C (CHC) and its treatment are associated with a variety of patient-reported symptoms and impacts. Individuals with CHC may experience symptoms including nausea, fatigue, musculoskeletal and abdominal pain, and headaches [3] Neuropsychiatric symptoms such as depression, fatigue, irritability, and malaise are reported by patients with both acute and chronic hepatitis infection, with depression being the most frequently reported [4]. The current standard of care (SOC) for treating CHC patients with chronic infection is a regimen of interferon alpha (IFN-α) and ribavirin (RBV) This combination has been found to result in the highest sustained response rates in clinical trials [7,8,9]. Treatment with IFN-α and RBV can cause many severe symptoms including physical fatigue, flu-like symptoms, hair loss, gastrointestinal (GI) symptoms, headache, and neuropsychological symptoms including mental fatigue, concentration difficulties, depression, and irritability [1] These symptoms in turn impact HRQL and patients’ ability to perform everyday activities [3]
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