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Review
. 2025 Jul;91(1):106514.
doi: 10.1016/j.jinf.2025.106514. Epub 2025 May 22.

Clinical trials for Hepatitis Delta Virus in the WHO African region: A neglected virus among neglected viruses

Marion Delphin  1 , James Campbell  2 , Eloi R Verrier  3 , Motswedi Anderson  4 , Gloria Sukali  5 , Tongai Maponga  6 , Alexander Stockdale  7 , Philippa C Matthews  8
Affiliations
Free article
Review

Clinical trials for Hepatitis Delta Virus in the WHO African region: A neglected virus among neglected viruses

Marion Delphin et al. J Infect. 2025 Jul.
Free article

Abstract

Objectives: We set out to evaluate the extent to which Hepatitis Delta Virus (HDV) Clinical Trials (CT) include populations from the World Health Organisation (WHO) African region, aiming to highlight inequities and advocate for global investment in inclusive HDV research.

Methods: We screened the clinicaltrial.gov and the WHO International Clinical Trials Registry Platform (ICTRP) repositories for 'Hepatitis Delta virus' and 'HDV' related CT. Datasets were merged using R v.4.2.1. We classified studies according to location and associated WHO region.

Results: We identified a total of 47 CT on HDV, mainly conducted in Europe (69.3%), Western Pacific (19.6%) and the Americas (8.5%). Despite the highest estimated anti-HDV seroprevalence in the general population, there were no CT registered in the WHO African region. CT are still predominantly done in the regions of initial drug discovery, as seen with bulevirtide (Europe) and lonafarnib (Americas).

Conclusion: HDV-focused CT are needed in the WHO African region, as the region with the highest disease burden, and unique genotypes (5-8); to evaluate efficacy of novel anti-HDV compounds and to ensure that new treatments can be distributed and deployed as they become available.

Keywords: Clinical trials equity; Health equity; Hepatitis Delta Virus; WHO African region.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships, which may be considered as potential competing interests: PCM has previously received funding from GSK to support a doctoral student in her team, outside the scope of this paper. ERV received funding from Eiger Biopharmaceuticals and EIT PHARMA, INC. in the frame of the D-LIVR Phase III study. ERV acknowledges funding from the interdisciplinary Thematic Institute IMCBio+, as part of the ITI 2021–2028 program of the University of Strasbourg, CNRS and Inserm, supported by IdEx Unistra (ANR-10-IDEX-0002), and by SFRI-STRAT’US project (ANR-20-SFRI-0012) and EUR IMCBio (ANR-17-EURE-0023) under the framework of the French Investments for the Future Program.

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