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

Abstract

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).

The Lived Experience of Chronic Hepatitis B: A Broader View of Its Impacts and Why We Need a Cure

“…Fears about personal health can also be exacerbated by the physical symptoms of the disease. In large, multi-national studies of patient-reported CHB outcomes [41,42], poorer health-related quality of life is consistently related to advanced liver disease. Anxiety and other depressive symptoms are common, particularly as physical symptoms manifest due to advancing liver disease [43][44][45][46].…”

“…Anxiety and other depressive symptoms are common, particularly as physical symptoms manifest due to advancing liver disease [43][44][45][46]. In contrast, those without symptoms of liver disease report lower (but still present [47]) impacts on mental well-being in relation to health-related matters [41,42].…”

Liver disease symptoms are associated with higher risk of adverse clinical outcomes: A longitudinal study of North American adults with chronic Hepatitis B

“…The SCL is a 10‐item instrument originally developed by the NIDDK to quantify symptoms associated with chronic liver disease. It has been modified for utilisation in several NIDDK‐funded research networks of various liver disease populations 7,9 . Participants were asked, “ During the last month, how much have you been bothered by the following symptom: fatigue, itching, pain over liver, irritability, depression/sadness, nausea, poor appetite, weight loss, dark urine, jaundice .” For each symptom, the participant marked a box to indicate how bothered they were by the symptom in the last month: None at all (0), A little bit (1), moderately (2), quite a bit (3), or extremely (4).…”

“…Participants were asked, “ During the last month, how much have you been bothered by the following symptom: fatigue, itching, pain over liver, irritability, depression/sadness, nausea, poor appetite, weight loss, dark urine, jaundice .” For each symptom, the participant marked a box to indicate how bothered they were by the symptom in the last month: None at all (0), A little bit (1), moderately (2), quite a bit (3), or extremely (4). If they did not have the symptom, they marked “None at all.” For this analysis, a total CHB symptom score was created at each study visit by summing the 10 symptom scores with a possible range from 0 to 40, with higher scores indicating worse symptoms 7 …”

“…We previously published a cross‐sectional analysis of data from 876 adults living in the United States and Canada who participated in the Hepatitis B Research Network (HBRN) Adult Cohort Study 7 . Overall, this multi‐ethnic North American cohort had mild liver disease and reported favourable HRQoL on the SF‐36 and minimal CHB symptoms on a 10‐item Symptom Checklist developed by the NIDDK.…”