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

Marion Delphin; Khadija Said Mohammed; Louise O Downs; Sheila F Lumley; Elizabeth Waddilove; Dorcas Okanda; Nadia Aliyan; Marije Van Schalkwyk; Motswedi Anderson; Ponsiano Ocama; Tongai Maponga; Judith Torimiro; Collins Iwuji; Thumbi Ndung'u; Philippa C Matthews; Jantjie Taljaard

doi:10.1016/S2468-1253(23)00315-1

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

Lancet Gastroenterol Hepatol. 2024 Apr;9(4):383-392. doi: 10.1016/S2468-1253(23)00315-1. Epub 2024 Feb 15.

Authors

Marion Delphin¹, Khadija Said Mohammed², Louise O Downs³, Sheila F Lumley⁴, Elizabeth Waddilove¹, Dorcas Okanda⁵, Nadia Aliyan⁶, Marije Van Schalkwyk⁷, Motswedi Anderson⁸, Ponsiano Ocama⁹, Tongai Maponga¹⁰, Judith Torimiro¹¹, Collins Iwuji¹², Thumbi Ndung'u¹³, Philippa C Matthews¹⁴, Jantjie Taljaard⁷

Affiliations

¹ The Francis Crick Institute, London, UK.
² The Francis Crick Institute, London, UK; Division of Biosciences, Faculty of Life Sciences, University College London, London, UK.
³ Nuffield Department of Medicine, University of Oxford, Oxford, UK; Department of Infectious Diseases and Microbiology, John Radcliffe Hospital, Oxford, UK; Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
⁴ Nuffield Department of Medicine, University of Oxford, Oxford, UK; Department of Infectious Diseases and Microbiology, John Radcliffe Hospital, Oxford, UK.
⁵ Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
⁶ Kilifi County Hospital, Kilifi, Kenya.
⁷ Division of Infectious Diseases, Department of Medicine, Stellenbosch University-Tygerberg Academic Hospital, Cape Town, South Africa.
⁸ The Francis Crick Institute, London, UK; Botswana Harvard AIDS Institute Partnership, Princess Marina Hospital, Gaborone, Botswana; Africa Health Research Institute, Durban, South Africa.
⁹ College of Health Sciences, Makerere University, Kampala, Uganda.
¹⁰ Division of Medical Virology, Stellenbosch University-National Health Laboratory Service Tygerberg Business Unit, Cape Town, South Africa.
¹¹ Molecular Biology Laboratory, Chantal Biya International Reference Centre for AIDS Research, Yaounde, Cameroon.
¹² Africa Health Research Institute, Durban, South Africa; Department of Global Health and Infection, Brighton and Sussex Medical School, University of Sussex, Brighton, UK.
¹³ Division of Infection and Immunity, University College London, London, UK; Africa Health Research Institute, Durban, South Africa.
¹⁴ The Francis Crick Institute, London, UK; Division of Infection and Immunity, University College London, London, UK; Nuffield Department of Medicine, University of Oxford, Oxford, UK; Department of Infectious Diseases, University College London Hospital, London, London, UK. Electronic address: [email protected].

Abstract

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.

Publication types

Review

MeSH terms

Hepatitis B virus
Hepatitis B* / drug therapy
Hepatitis B* / epidemiology
Hepatitis B* / prevention & control
Hepatitis B, Chronic* / drug therapy
Hepatitis B, Chronic* / epidemiology
Humans
World Health Organization

Abstract

Publication types

MeSH terms

Grants and funding