Comparing health-related quality of life for chronic hepatitis B patients with and without treatment cessation: findings from the prospective multicentre COIN-B trial

Abstract

Background and aims: Nucleos(t)ide analogues (NUC) are the current first line treatment for chronic hepatitis B (CHB). The drugs efficiently suppress viral replication, but HBV seroclearance often requires decades of continuous therapy. While NUC cessation is increasingly explored as a strategy to induce functional cure, its impact on health-related quality of life (HRQoL) is unknown. We evaluated HRQoL in patients who discontinued NUC therapy with those continuing treatment within the COIN-B trial (NCT04779970, EudraCT 2021-001003-32). Method: This prospective multicentre study was conducted across 26 Belgian hospitals. HRQoL was assessed at baseline and at weeks 4, 12, 24, and 72, using the EQ-5D-5L with EQ-Visual Analogue Scale (VAS), and were valued using the Belgian value set. Descriptive statistics were calculated for each time point and study arm. Determinants of EQ-5D-5L utility values were explored using linear mixed-effects models with random intercepts for patients to account for within-subject correlation. Results: A total of 146 patients were included (91 stop treatment arm; 55 control arm). Patients who discontinued NUC treatment consistently reported high mean EQ-5D-5L utility (>0.9) at all time points. Mean utilities in the control arm were slightly lower but remained