Clinical and patient-reported outcome profile of patients with hepatitis B viral infection from the Global Liver Registry™
Recommended Citation
Younossi ZM, Yu ML, Yilmaz Y, Alswat KA, Buti M, Fernandez MIC, Papatheodoridis G, Hamid SS, El-Kassas M, Chan WK, Duseja AK, Gordon SC, Eguchi Y, Isakov VA, Roberts SK, Fan JG, Singal AK, Romero-Gómez M, Ahmed A, Ong J, Lam BP, Younossi I, Nader F, Racila A, Stepanova M, and Alqahtani S. Clinical and patient-reported outcome profile of patients with hepatitis B viral infection from the Global Liver Registry™. J Viral Hepat 2023.
Document Type
Article
Publication Date
1-4-2023
Publication Title
Journal of viral hepatitis
Abstract
Chronic hepatitis B (CHB) infection is one of the most common causes of cirrhosis and liver cancer worldwide. Our aim was to assess clinical and patient-reported outcome (PRO) profile of CHB patients from different regions of the world using the Global Liver Registry. The CHB patients seen in real-world practices are being enrolled in the Global Liver Registry. Clinical and PRO (FACIT-F, CLDQ, WPAI) data were collected and compared to baseline data from CHB controls from clinical trials. The study included 1818 HBV subjects (48 ± 13 years, 58% male, 14% advanced fibrosis, 7% cirrhosis) from 15 countries in 6/7 Global Burden of Disease super-regions. The rates of advanced fibrosis varied (3-24%). The lowest PRO scores across multiple domains were in HBV subjects from the Middle East/North Africa (MENA), the highest - Southeast/East and South Asia. Subjects with advanced fibrosis had PRO impairment in 3 CLDQ domains, Activity of WPAI (p < 0.05). HBV subjects with superimposed fatty liver had more PRO impairments. In multivariate analysis adjusted for location, predictors of PRO impairment in CHB included female sex, advanced fibrosis, and non-hepatic comorbidities (p < 0.05). In comparison to Global Liver Registry patients, 242 controls from clinical trials had better PRO scores (Abdominal, Emotional, and Systemic scores of CLDQ, all domains of WPAI) (p < 0.05). In multivariate analysis with adjustment for location and clinicodemographic parameters, the associations of PROs with the enrollment setting (real-life Global Liver Registry vs. clinical trials) were no longer significant (all p > 0.10). The clinico-demographic portrait of CHB patients varies across regions of the world and enrollment settings. Advanced fibrosis and non-hepatic comorbidities are independently associated with PRO impairment in CHB patients.
PubMed ID
36601668
ePublication
ePub ahead of print
