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Clinical and Patient-Reported Outcome Profile of Patients with Hepatitis B Viral Infection from the Global Liver Registry™.

Clinical and Patient-Reported Outcome Profile of Patients with Hepatitis B Viral Infection from the Global Liver Registry™. Journal of viral hepatitis Younossi, Z. M., Yu, M. L., Yilmaz, Y., Alswat, K. A., Buti, M., Fernandez, M. I., Papatheodoridis, G., Hamid, S. S., El-Kassas, M., Chan, W. K., Duseja, A. K., Gordon, S. C., Eguchi, Y., Isakov, V. A., Roberts, S. K., Fan, J. G., Singal, A. K., Romero-Gómez, M., Ahmed, A., Ong, J., Lam, B. P., Younossi, I., Nader, F., Racila, A., Stepanova, M., Alqahtani, S. 2023

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.

View details for DOI 10.1111/jvh.13800

View details for PubMedID 36601668