Clinical and patient-reported outcome profile of patients with hepatitis B viral infection from the Global Liver Registry™

Zobair M Younossi; Ming-Lung Yu; Yusuf Yilmaz; Khalid Aida Alswat; Maria Buti; Marlen Ivon Castellanos Fernandez; Georgios Papatheodoridis; Saeed S Hamid; Mohamed El-Kassas; Wah Kheong Chan; Ajay K Duseja; Stuart C Gordon; Yuichiro Eguchi; Vasily A Isakov; Stuart K Roberts; Jian-Gao Fan; Ashwani K Singal; Manuel Romero-Gómez; Aijaz Ahmed; Janus Ong; Brian P Lam; Issah Younossi; Fatema Nader; Andrei Racila; Maria Stepanova; Saleh Alqahtani

doi:10.1111/jvh.13800

Clinical and patient-reported outcome profile of patients with hepatitis B viral infection from the Global Liver Registry™

J Viral Hepat. 2023 Apr;30(4):335-344. doi: 10.1111/jvh.13800. Epub 2023 Jan 11.

Authors

Zobair M Younossi^{1

2

3}, Ming-Lung Yu^{4

5}, Yusuf Yilmaz^{6

7}, Khalid Aida Alswat⁸, Maria Buti⁹, Marlen Ivon Castellanos Fernandez¹⁰, Georgios Papatheodoridis¹¹, Saeed S Hamid¹², Mohamed El-Kassas¹³, Wah Kheong Chan¹⁴, Ajay K Duseja¹⁵, Stuart C Gordon¹⁶, Yuichiro Eguchi¹⁷, Vasily A Isakov¹⁸, Stuart K Roberts^{19

20}, Jian-Gao Fan²¹, Ashwani K Singal²², Manuel Romero-Gómez²³, Aijaz Ahmed²⁴, Janus Ong²⁵, Brian P Lam^{1

2

3}, Issah Younossi²⁶, Fatema Nader²⁶, Andrei Racila²⁶, Maria Stepanova^{1

2

3

26}, Saleh Alqahtani^{26

27}

Affiliations

¹ Center for Liver Diseases, Department of Medicine, Inova Fairfax Medical Campus, Falls Church, Virginia, USA.
² Inova Medicine Service Line, Inova Health System, Falls Church, Virginia, USA.
³ Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia, USA.
⁴ School of Medicine, College of Medicine, National Sun Yat-sen University, Kaohsiung, Taiwan.
⁵ Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
⁶ Liver Research Unit, Institute of Gastroenterology, Marmara University, İstanbul, Turkey.
⁷ Department of Gastroenterology, School of Medicine, Recep Tayyip Erdoğan University, Rize, Turkey.
⁸ Liver Disease Research Center, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
⁹ Liver Unit, Universitario Vall d'Hebron and CIBEREHD del Instituto Carlos III, Barcelona, Spain.
¹⁰ Institute of Gastroenterology, University of Medical Science, Havana, Cuba.
¹¹ Academic Department of Gastroenterology, General Hospital of Athens "Laiko", Medical School of the National and Kapodistrian University of Athens, Athens, Greece.
¹² Department of Medicine, Aga Khan University, Karachi, Pakistan.
¹³ Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.
¹⁴ Department of Gastroenterology and Hepatology, University of Malaya, Kuala Lumpur, Malaysia.
¹⁵ Department of Hepatology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
¹⁶ Department of Hepatology and Gastroenterology, Henry Ford Hospital System, Wayne State University School of Medicine, Detroit, Michigan, USA.
¹⁷ Loco Medical General Institute, Saga, Japan.
¹⁸ Division of Gastroenterology and Hepatology, Federal Research Center of Nutrition and Biotechnology, Moscow, Russia.
¹⁹ Department of Medicine, Monash University, Melbourne, Australia.
²⁰ Department of Gastroenterology and Hepatology, Alfred Health, Melbourne, Australia.
²¹ Department of Gastroenterology, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
²² University of South Dakota and Avera Transplant Institute, Sioux Falls, South Dakota, USA.
²³ Digestive Diseases Department, Virgen del Rocío University Hospital, Institute of Biomedicine of Seville, University of Seville, Seville, Spain.
²⁴ Division of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford, California, USA.
²⁵ College of Medicine, University of the Philippines, Manila, Philippines.
²⁶ Center for Outcomes Research in Liver Diseases, Washington, DC, USA.
²⁷ King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia.

PMID: 36601668
DOI: 10.1111/jvh.13800

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.

Keywords: emotional well-being; fatigue; fatty liver; physical functioning; viral hepatitis; work productivity.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antiviral Agents / therapeutic use
Drug Therapy, Combination
Female
Hepatitis B virus
Hepatitis B* / drug therapy
Hepatitis B, Chronic* / drug therapy
Humans
Liver Cirrhosis / drug therapy
Male
Patient Reported Outcome Measures
Sofosbuvir / therapeutic use
Surveys and Questionnaires
Virus Diseases*

Substances

Antiviral Agents
Sofosbuvir