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

Journal

The lancet. Gastroenterology & hepatology
ISSN: 2468-1253
Titre abrégé: Lancet Gastroenterol Hepatol
Pays: Netherlands
ID NLM: 101690683

Informations de publication

Date de publication:
14 Feb 2024
Historique:
received: 18 07 2023
revised: 31 08 2023
accepted: 11 09 2023
medline: 18 2 2024
pubmed: 18 2 2024
entrez: 17 2 2024
Statut: aheadofprint

Résumé

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.

Identifiants

DOI: 10.1016/S2468-1253(23)00315-1 PMID: 38367632
pubmed: 38367632
pii: S2468-1253(23)00315-1
doi: 10.1016/S2468-1253(23)00315-1
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

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.

Auteurs

Marion Delphin (M)

The Francis Crick Institute, London, UK.

Khadija Said Mohammed (KS)

The Francis Crick Institute, London, UK; Division of Biosciences, Faculty of Life Sciences, University College London, London, UK.

Louise O Downs (LO)

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.

Sheila F Lumley (SF)

Nuffield Department of Medicine, University of Oxford, Oxford, UK; Department of Infectious Diseases and Microbiology, John Radcliffe Hospital, Oxford, UK.

Elizabeth Waddilove (E)

The Francis Crick Institute, London, UK.

Dorcas Okanda (D)

Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.

Nadia Aliyan (N)

Kilifi County Hospital, Kilifi, Kenya.

Marije Van Schalkwyk (M)

Division of Infectious Diseases, Department of Medicine, Stellenbosch University-Tygerberg Academic Hospital, Cape Town, South Africa.

Motswedi Anderson (M)

The Francis Crick Institute, London, UK; Botswana Harvard AIDS Institute Partnership, Princess Marina Hospital, Gaborone, Botswana; Africa Health Research Institute, Durban, South Africa.

Ponsiano Ocama (P)

College of Health Sciences, Makerere University, Kampala, Uganda.

Tongai Maponga (T)

Division of Medical Virology, Stellenbosch University-National Health Laboratory Service Tygerberg Business Unit, Cape Town, South Africa.

Judith Torimiro (J)

Molecular Biology Laboratory, Chantal Biya International Reference Centre for AIDS Research, Yaounde, Cameroon.

Collins Iwuji (C)

Africa Health Research Institute, Durban, South Africa; Department of Global Health and Infection, Brighton and Sussex Medical School, University of Sussex, Brighton, UK.

Thumbi Ndung'u (T)

Division of Infection and Immunity, University College London, London, UK; Africa Health Research Institute, Durban, South Africa.

Philippa C Matthews (PC)

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: philippa.matthews@crick.ac.uk.

Jantjie Taljaard (J)

Division of Infectious Diseases, Department of Medicine, Stellenbosch University-Tygerberg Academic Hospital, Cape Town, South Africa.

Classifications MeSH