Successful Amendment of an Existing Hepatitis B Screening Programme by a Guideline Recommended Hepatitis D Screening in the Primary Care Setting

Toni Herta; Anna Joachim-Richter; David Petroff; Benno Wölk; Ingmar Wolffram; Thomas Berg; Jan Kramer; Olaf Bätz; Johannes Wiegand

doi:10.1111/apt.18424

Successful Amendment of an Existing Hepatitis B Screening Programme by a Guideline Recommended Hepatitis D Screening in the Primary Care Setting

Aliment Pharmacol Ther. 2024 Dec 4. doi: 10.1111/apt.18424. Online ahead of print.

Authors

Toni Herta^{1

2

3}, Anna Joachim-Richter⁴, David Petroff⁵, Benno Wölk⁴, Ingmar Wolffram⁶, Thomas Berg¹, Jan Kramer⁴, Olaf Bätz⁴, Johannes Wiegand¹

Affiliations

¹ Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, Leipzig, Germany.
² Department of Hepatology and Gastroenterology, Campus Virchow-Klinikum and Campus Charité Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany.
³ Berlin Institute of Health at Charité-Universitätsmedizin Berlin, BIH Biomedical Innovation Academy, BIH Charité Clinician Scientist Program, Berlin, Germany.
⁴ LADR Laboratory Group Dr. Kramer & Colleagues, Geesthacht, Germany.
⁵ Clinical Trial Centre Leipzig, University of Leipzig, Leipzig, Germany.
⁶ General Practitioner, Paderborn, Germany.

PMID: 39628411
DOI: 10.1111/apt.18424

Abstract

Background: Despite European guidelines recommending anti-hepatitis D virus (HDV) screening for all hepatitis B surface antigen (HBsAg)-positive cases, screening rates remain insufficient.

Aims: We analysed anti-HDV screening rates in primary care and implemented prospective HDV screening in HBsAg-positive cases identified in the preventive medical examination from the age of 35 ("Check-Up 35+").

Methods: From 2012 to 2021, we reviewed anti-HDV and HDV RNA test rates in HBsAg-positive patients at 11 sites of a large German laboratory group. From 2022 to 2023, we prospectively screened HBsAg-positive samples from the "Check-Up 35+" for anti-HDV. Anti-HDV positive patients were then contacted again for HDV RNA testing.

Results: Retrospectively, 2792/13,905 (20%) HBsAg-positive cases were tested for anti-HDV, with 142/2792 (5.1%) being positive. HDV RNA was tested in 57/142 (40%) anti-HDV-positive cases, with 26/57 (46%) being positive. In the prospective screening, 1159/225,901 (0.51%) individuals were HBsAg-positive. Of these, 700 (60%) were tested for anti-HDV, with 18/700 (2.6%) positive test results. 4/18 (22%) were successfully contacted again for HDV RNA analysis, with one case testing positive. Neither the HBsAg nor the anti-HDV positive result was known prior to screening in these cases. Anti-HDV testing could not be performed in 459/1159 (40%) HBsAg-positive cases, primarily due to insufficient blood sample volume (310/459 cases, 68%), with others missed due to logistical errors.

Conclusions: Retrospective data show insufficient anti-HDV screening in clinical routine. The prospective anti-HDV screening provides a blueprint for using existing hepatitis B virus screening programms for population-based HDV double reflex testing, provided that adequate logistical prerequisites are established.

Trial registration: German Clinical Trial Register: DRKS00029180.

Keywords: HDV prevalence; HDV reflex testing; HDV screening; check‐up 35+; primary care.

Grants and funding

IN-DE-980-6534/Gilead Sciences