Under-representation of the WHO African region in clinical trials of interventions against hepatitis B virus infection.

The WHO African region bears a disproportionate burden of morbidity and mortality related to chronic hepatitis B virus (HBV) infection and accounts for an estimated 70% of new HBV infections worldwide. We investigated the extent to which HBV clinical trials represented populations in this region by searching the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov for interventional clinical trials published in English between database inception and May 29, 2023, using the search term "Hepatitis B". We identified 1804 unique clinical trials, of which 18 (1·0%) recorded involvement of the WHO African region. There is no evidence that the number of HBV clinical trials in this region has improved over time. The diversity of new interventions and industry sponsorship in the WHO African region were low, with trials of HBV comparing poorly with those of other endemic infectious diseases (eg, malaria, HIV, and SARS-CoV-2). HBV research and clinical trial investigations have neglected the WHO African region, leading to profound health inequities. HBV clinical trials are urgently needed to evaluate the efficacy of newly discovered therapeutics and to ensure that interventions can be equitably distributed and deployed as they become available.
Competing Interests: Declaration of interests MD, EW, and PCM receive funding from The Francis Crick Institute. PCM is funded by a Wellcome fellowship (ref 110110/Z/15/Z) and the University College London National Institute for Health and Care Research Biomedical Research Centre and receives funding from GlaxoSmithKline to support a doctoral student in her team. LOD and SFL receive doctoral funding from the Wellcome Trust. CI has received research grant funding from Gilead Sciences. All other authors declare no competing interests. Editorial note: The Lancet Group takes a neutral position with respect to territorial claims in published maps, text, and institutional affiliations.
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