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

Summary 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).