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

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.