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. 2020 Feb;51(4):457-468.
doi: 10.1111/apt.15618. Epub 2020 Jan 14.

Patient-reported outcomes in a large North American cohort living with chronic hepatitis B virus: a cross-sectional analysis

Donna M Evon  1 , Hsing-Hua S Lin  2 , Mandana Khalili  3 , Robert J Fontana  4 , Colina Yim  5 , Abdus S Wahed  2 , Michael W Fried  1 , Jay H Hoofnagle  6 ; Hepatitis B Research Network (HBRN)
Collaborators, Affiliations

Patient-reported outcomes in a large North American cohort living with chronic hepatitis B virus: a cross-sectional analysis

Donna M Evon et al. Aliment Pharmacol Ther. 2020 Feb.

Abstract

Background: Patient-reported outcomes (PROs) such as health-related quality of life (HRQoL) and symptoms associated with chronic hepatitis B viral (HBV) infection have not been well-described in North American cohorts.

Aims: To evaluate several PROs and associations with HBV disease activity markers.

Methods: Cross-sectional analysis including 876 adults who completed PRO measures during the Hepatitis B Research Network Adult Cohort Study. Participants on HBV treatment were excluded. Outcomes included: HRQoL using the SF-36 mental component summary and physical component summary scores; symptom burden using a 10-item Total Symptom Checklist and fatigue using an instrument from the Patient-Reported Outcomes Measurement Information System®. Covariates included laboratory markers of disease severity, virological status, comorbidities and medications.

Results: Median age was 42 (range: 19-79), 51% were female, 73% Asian, 19% HBeAg (+), 2% had AST-platelet ratio index (APRI) ≥1.5 and 74% without comorbidities. Mean mental component summary T-score = 52, physical component summary T-score = 54 and PROMIS Fatigue T-score = 47. On a scale from 0 (none) to 40 (extreme), the mean Symptom Checklist score = 3 and 25% reported no symptoms. The most frequent symptoms were fatigue (60%), irritability (32%) and itching (32%). Most symptoms were 'a little bit' bothersome. In multivariable regressions, APRI ≥1.50 and more comorbidities were associated with worse patient-reported outcomes; virological markers were not. Adding the Total Symptom Checklist score to original regression models increased explanation of variation in the mental component summary score from 4% to 44% and the Physical Component Summary Score from 17% to 34%.

Conclusions: Untreated North American HBV patients with mild liver disease report favourable health-related quality of life and minimal symptoms. HBV does not impact health-related quality of life unless advanced liver disease or comorbidities are present. High symptom burden explains substantial variation in health-related quality of life. (CT.gov identifier: NCT01263587).

Keywords: SF-36; fatigue; functioning; liver; quality of life; symptom.

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Conflict of interest statement

Financial Support

Statement of Interest: Donna Evon receives research grant funding (to UNC) from Gilead Sciences Inc and Merck Sharp and Dohme. Michael Fried has received research funding from and served as a consultant for AbbVie, BMS, Gilead, and Merck, and TARGET PharmaSolutions. Stock in TARGET PharmaSolutions is held in an independently managed trust. Mandana Khalili received research grant funding (to her institution) from Gilead Sciences Inc and Intercept Pharmaceutical and has served as a scientific consultant for Gilead Science. Robert Fontana has received research support from Gilead, BMS, and Abbvie and provides consulting to Alynam. Colina Yim has received speakers honorarium from Abbvie Canada, and consulting fees from Abbvie Canada and Lupin Pharma Canada. Hsing-Hua S. Lin, Abdus S. Wahed, and Jay H. Hoofnagle have no conflict of interests to disclose.

Declaration of Funding Interest: The HBRN was funded as a Cooperative Agreement between the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the following investigators: Lewis R. Roberts, MB, ChB, PhD (U01-DK082843), Anna Suk-Fong Lok, MD (U01-DK082863), Steven H. Belle, PhD, MScHyg (U01-DK082864), Kyong-Mi Chang, MD (U01-DK082866), Michael W. Fried, MD (U01-DK082867), Adrian M. Di Bisceglie, MD (U01-DK082871), William M. Lee, MD (U01-DK082872), Harry L. A. Janssen, MD, PhD (U01-DK082874), Daryl T-Y Lau, MD, MPH (U01-DK082919), Richard K. Sterling, MD, MSc (U01-DK082923), Steven-Huy B. Han, MD (U01-DK082927), Robert C. Carithers, MD (U01-DK082943), Mandana Khalili, MD (U01-DK082944), an interagency agreement with NIDDK: Lilia M. Ganova-Raeva, PhD (A-DK-3002–001) and support from the intramural program, NIDDK, NIH: Marc G. Ghany, MD. Additional funding to support this study was provided to Kyong-Mi Chang, MD, the Immunology Center, (NIH/NIDDK Center of Molecular Studies in Digestive and Liver Diseases P30DK50306, NIH Public Health Service Research Grant M01-RR00040), Richard K. Sterling, MD, MSc (UL1TR000058, NCATS (National Center for Advancing Translational Sciences, NIH), Norah A. Terrault, MD, MPH (CTSA Grant Number UL1TR000004), Michael W. Fried, MD (CTSA Grant Number UL1TR001111), and Anna Suk-Fong Lok (CTSA Grant Number UL1RR024986, U54TR001959.) Additional support was provided by Gilead Sciences, Inc. and Roche Molecular Systems via a CRADA through the NIDDK.

Figures

Figure 1:
Figure 1:
Study flow chart
Figure 2:
Figure 2:. Distribution of each patient-reported outcome measure.
Note: Higher scores in the physical component summary score (PCS) and mental component summary score (MCS) indicate better physical and mental health. Higher scores in Fatigue indicate more fatigue. Higher Total Symptom Checklist scores (T-SCL) indicate higher numbers of symptoms or more severe symptoms.
Figure 3:
Figure 3:. Composition of symptoms ranging from “None” to “Extremely”
Note: Subcategories with less than 1% are not labeled in the figure.
See this image and copyright information in PMC

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