Development and evaluation of a simple treatment eligibility score (HEPSANET) to decentralise hepatitis B care in Africa: a cross-sectional study.

BACKGROUND

Hepatitis B virus (HBV) elimination requires expanding and decentralising HBV care services. However, peripheral health facilities lack access to diagnostic tools to assess eligibility for antiviral therapy. Through the Hepatitis B in Africa Collaborative Network (HEPSANET), we aimed to develop and evaluate a score using tests generally available at lower-level facilities, to simplify the evaluation of antiviral therapy eligibility in people living with HBV.

METHODS

We surveyed the availability of clinical and laboratory parameters across different health-care levels in sub-Saharan Africa. We used data from the HEPSANET dataset, the largest cross-sectional dataset of treatment-naive people living with HBV in sub-Saharan Africa, to derive and validate the score. Participants from this dataset were included in the analysis if they were aged 18 years or older and had liver fibrosis stages determined by a liver stiffness measurement or liver histopathology. Participants with co-infections or metabolic disorders were excluded. We allocated participants to the derivation and validation sets by geographical site. In the derivation set, we used stepwise logistic regression to identify the best performing parameters for identifying participants that met the 2017 European Association for the Study of the Liver (EASL) criteria. Regression coefficients were converted into integer points to construct simplified algorithms for different health-care levels. In the validation set, we estimated the area under the receiver operating characteristic, sensitivity, and specificity of the simplified algorithm for identifying antiviral therapy eligibility defined by the 2017 EASL criteria.

FINDINGS

At 11 sites from eight countries that returned surveys, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count were generally available at district hospital levels, and hepatitis B e antigen and point-of-care HBV DNA tests were available only at regional and provincial hospital levels or above. Among 2895 participants included from the HEPSANET database (1740 [60·1%] male, 1155 [39·9%] female), 409 (14·1%) met EASL antiviral therapy eligibility criteria. In the derivation set, the optimal district-level hospital score was: ALT (IU/L), less than 40 (0 points), 40-79 (+1), 80 or greater (+2); AST (IU/L), less than 40 (0), 40-79 (+1), 80 or greater (+2); and platelet counts (10

INTERPRETATION

Using a score incorporating platelet counts, AST, and ALT, the majority of people living with HBV requiring antiviral therapy can be identified. Our findings suggest that clinical staging can be decentralised down to district hospital level in sub-Saharan Africa.

FUNDING

European Association for the Study of the Liver Foundation, John C Martin Foundation.

TRANSLATION

For the French translation of the abstract see Supplementary Materials section.

Informations de copyright

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Déclaration de conflit d'intérêts

Declaration of interests CWS has received speaker bureau honoraria from Gilead Sciences and Abbott, as well as travel support from Gilead Sciences. ES has received a research grant from Gilead Sciences. GW has received a research grant from Roche Diagnostics, Roche Molecular, and Gilead Sciences, and consulting fees from Gilead Sciences, Merck Sharp and Dohme, and ViiV. MA has received research grants from Prenetics, Pfizer, and Johnson & Johnson; consulting fees from Prenetics; honoraria from Pfizer; travel support from WHO; reports planned patents for Ramanomics and LAMP GC/CT/HSV/HBV; and is an unpaid board member of the Charity E3 initiative. MSo has received speaker bureau honoraria from Roche and Gilead Sciences, and travel support from Gilead Sciences. MV has received funding from the US National Institutes of Health (R01AI147727), and travel support from Africa Centres for Disease Control and Prevention. PCM has received funding from the Wellcome Trust (110110) and the Francis Crick Institute, and also reports sponsorship from GSK for a doctoral student, outside the scope of the current work. YS has received a research grant and honoraria for lectures from Gilead Sciences and research materials from Abbott Laboratories and Fujirebio. All other authors declare no competing interests.