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

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 nonhepatic comorbidities are independently associated with PRO impairment in CHB patients.

Clinical and patient‐reported outcomes in patients with chronic hepatitis B and C and non‐alcoholic fatty liver disease from real‐world practices in Saudi Arabia, Turkey and Egypt

“…In contrast, patients with NAFLD/NASH reported the lowest HRQoL scores and had the most work and activity impairment. This is consistent with previous reports that patients with early liver disease due to hepatitis B virus (HBV) infection can be minimally symptomatic and usually not accompanied by multiple non‐hepatic comorbidities; as a result, these patients suffer the least impairment of HRQoL 17,18 …”

“…This is consistent with previous reports that patients with early liver disease due to hepatitis B virus (HBV) infection can be minimally symptomatic and usually not accompanied by multiple non-hepatic comorbidities; as a result, these patients suffer the least impairment of HRQoL. 17,18 In contrast, patients with NAFLD/NASH had the most impairment of HRQoL. In fact, predictors for impairment of HRQoL, after adjusting for the country of enrolment and CLD aetiology, were parameters more prevalent among those with NAFLD and NASH, such as having non-hepatic comorbidities of obesity, T2D, hyperlipidaemia, anxiety, depression, fatigue and sleep apnoea as well as not engaging in regular exercise; the latter is also consistent with prior reports.…”

“…The study expands on recent findings that provided PROs by global region. Investigators found that the Middle East had lower PROs compared to other regions of the world, such as high‐income countries and Eastern Asia 8,9,17 . Herein, we have provided results demonstrating three countries may be impacted more by one CLD than another.…”

Effect of interferon therapy on quality of life in patients with chronic hepatitis B

“…Therefore, the psychosocial aspects of patients undergoing interferon therapy for CHB needs attention. Quality of life is a concept that integrates biomedical, sociological, and psychological aspects to provide a more comprehensive picture of health, and to assess the effectiveness of treatments 8 , 9 . Previous studies have shown that quality of life decreases in patients with chronic hepatitis C during interferon therapy 10 , 11 .…”