Patient‐reported outcomes in a large North American cohort living with chronic hepatitis B virus: a cross‐sectional analysis. Issue 4 (14th January 2020)

• Record Type: Journal Article
• Authors: Evon, Donna M.; Lin, Hsing‐Hua S.; Khalili, Mandana; Fontana, Robert J.; Yim, Colina; Wahed, Abdus S.; Fried, Michael W.; Hoofnagle, Jay H.
• Other Names: Niu Jianghe investigator.; Javaid Asad investigator.; Nasir Bilal investigator.; Susheela Ammu investigator.; Nasser Imad investigator.; Donovan Arley investigator.; Rusibamayila Nifasha investigator.; Foley Cara investigator.; Stahler Alisha C. investigator.; Stadheim Linda investigator.; Lake John investigator.; Lacher Philip investigator.; Rushing Kathryn investigator.; DeMarco Shaw Debra investigator.; Kessels Lisa investigator.; Klebert Michael K. investigator.; Noureldin Seham investigator.; La Danie investigator.; Liu Lucie investigator.; Kaznowski Diana investigator.; Chen Jiayun investigator.; Huang Fengfei investigator.; Vladutu Doinita investigator.; Cerocchi Orlando investigator.; Rowan Debra investigator.; Bass Sheila investigator.; Lilly Barbara investigator.; French Samuel investigator.; Peacock Velma investigator.; Geffen David investigator.; Peters Marion investigator.; Shobe Ashley investigator.; Davis Rayshawnda investigator.; Kuras Romuald investigator.; Ayala Claudia investigator.; Lau Ivy investigator.; Podolskaya Veronika investigator.; von Bakonyi Anna investigator.; DeVole Nata investigator.; McKenna Barbara investigator.; Choi Karen investigator.; Oberhelman Kelly investigator.; Kaza Sravanthi investigator.; Moran Isabel investigator.; Huddleston Leslie investigator.; Wong Richmond investigator.; Barritt A. Sidney investigator.; Marsh Tiffany investigator.; Metheny Vikki investigator.; Cardona Danielle investigator.; Smith Paula G. investigator.; Hofmann Charlotte investigator.; Wolfstone Alycia investigator.; Mooney Jody investigator.; Cardona‐Gonzalez Lupita investigator.; Fryzek Nancy investigator.; Rivera Elenita investigator.; Morris Nevitt investigator.; Haynes‐Williams Vanessa investigator.; Huang Amy investigator.; Nadal Catherine investigator.; Norman‐Wheeler Jaha investigator.; Sherker Averell H. investigator.; Torrance Rebecca J. investigator.; Hall Sherry R. investigator.; Valiga Mary E. investigator.; Torrey Keith investigator.; Levine Danielle investigator.; Keith James investigator.; Betts Michael investigator.; Montaner Luis J. investigator.; Averbach Frani investigator.; Haller Tamara investigator.; Hardison Regina investigator.; Kelley Stephanie investigator.; Lalama Christina investigator.; Lawlor Sharon investigator.; Lombardero Manuel investigator.; Pelesko Andrew investigator.; Stoliker Donna investigator.; Weiner Melissa investigator.; Zadorozny Ella investigator.; Zhao Qian investigator.;
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 51:Issue 4(2020)
• Page Start: 457
• Page End: 468
• Publication Date: 2020-01-14
• Subjects: fatigue -- functioning -- liver -- quality of life -- SF‐36 -- symptom; Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.15618
• Languages: English
• ISSNs: 0269-2813

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).