Ethnicity, genomic ancestry, and HBV genotype in off-treatment outcomes following nucleos(t)ide analogue cessation: a prospective multicentre trial (COIN-B)
Year: 2026
Type: article
Abstract: Nucleos(t)ide analogue (NUC) cessation can induce functional cure, but outcomes vary. Ethnicity has been suggested as a determinant, but definitions are subjective and inconsistent. In this prospective, multicentre trial (NCT04779970, EudraCT 2021-001003-32), 91 long-term NUC-treated, start-of-treatment HBeAg-negative patients without advanced fibrosis discontinued treatment; 84 completed the 72-week protocol. In the prespecified analysis, off-treatment viral control at week 72 (primary endpoint) did not differ between Caucasians (n = 41) and non-Caucasians (n = 43) (41.5% vs 30.2%, p = 0.28). In exploratory analyses, HBsAg loss (7.1%, secondary endpoint) occurred exclusively in European or North African/Middle Eastern genomic ancestries, and ≥1 log IU/mL HBsAg decline was less frequent in Asian or Sub-Saharan African ancestries (p = 0.01). Lower end-of-treatment HBsAg independently predicted viral control, HBsAg loss and decline. Adjusted for end-of-treatment HBsAg, genotypes C and D achieved less viral control and required more retreatment than genotype A. Here, we show that genomic ancestry and HBV genotype capture clinically relevant heterogeneity, calling for more granular characterization of eligible populations. Clinical trial information EudraCT: 2021-001003-32 . Date of registration: 7 June 2021 CTIS: 2024-511016-25-00 . Date of transition from EudraCT: 15 January 2025 Clinicaltrials.gov: NCT04779970 . Date of registration: 28 July 2021.
Source: Nature Communications
Authors: Arno Furquim d’Almeida, Axelle Vanderlinden, Arwin Ralf, Stefan Bourgeois, Jean-Pierre Mulkay, Thomas Sersté, Mathieu Struyve, Baro Deressa, Dirk Sprengers, Marie de Vos, Jos Callens, Bao Shihao, Silke François, Pierre Deltenre, Filip Janssens, Sergio Negrin Dastis, Peter Stärkel, Hans Orlent, Guy Van Roey, Xavier Verhelst, Christophe Moreno, Jean Delwaide, Christophe Van Steenkiste, Wim Verlinden, Isabelle Colle, Manfred Kayser, Benoît Kabamba Mukadi, Veerle Matheeussen, Thomas Vanwolleghem
Institutions: University of Antwerp, Antwerp University Hospital, Erasmus MC, Ziekenhuis aan de Stroom, Centre Hospitalier Universitaire de Saint-Pierre, Université Libre de Bruxelles, Erasmus Hospital, Ziekenhuis Oost-Limburg, Centre Hospitalier Universitaire Brugmann, Hôpital de Jolimont, AZ Klina, Universitair Ziekenhuis Brussel, Jessa Hospital, Grand Charleroi Hospital, Cliniques Universitaires Saint-Luc, AZ Sint-Jan, AZ Turnhout, Ghent University Hospital, University of Liège, AZ Maria Middelares, Onze Lieve Vrouwziekenhuis Hospital
Language: English
Topic: Hepatitis B Virus Studies
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $6,990
OpenAlex ID: W7221030943