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

for the Hepatitis B Research Network (HBRN)

    Research output: Contribution to journalArticlepeer-review

    8 Scopus citations


    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. ( identifier: NCT01263587).

    Original languageEnglish
    Pages (from-to)457-468
    Number of pages12
    JournalAlimentary Pharmacology and Therapeutics
    Issue number4
    StatePublished - 1 Feb 2020


    • SF-36
    • fatigue
    • functioning
    • liver
    • quality of life
    • symptom

    ASJC Scopus subject areas

    • Hepatology
    • Gastroenterology
    • Pharmacology (medical)


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