Background To eliminate hepatitis B virus (HBV) infection in resource-limited settings, expanding and decentralizing HBV care services is essential. However, peripheral health facilities often lack access to diagnostic tools necessary for assessing eligibility for antiviral therapy (AVT). Through a multi-regional collaboration in sub-Saharan Africa, we developed and evaluated a simplified algorithm using tests generally available at lower-level health facilities, to evaluate AVT eligibility for people with HBV-infection. Methods We first surveyed biomarker availability across different healthcare levels through HEPSANET (Hepatitis B in Africa Collaborative Network). We then divided the largest cross-sectional HBV dataset in sub-Saharan Africa into derivation and validation sets. In the derivation set, we selected a combination of locally-available tests that can best identify individuals meeting the 2017 European Association for the Study of the Liver (EASL) criteria using stepwise logistic regression. In the validation set, we estimated sensitivity and specificity of the simplified algorithms for AVT eligibility. Findings Across sites, transaminases (AST, ALT) and platelet counts were generally available at district hospital levels, while hepatitis B e antigen (HBeAg) and point-of-care HBV DNA tests (Xpert) were available at regional/provincial hospital levels or above. Among 2928 treatment-naïve HBV-infected individuals from seven countries, 398 (13·6%) met AVT eligibility per EASL guidelines. The following district-level score was developed: platelet counts (10^{9}/L), <100 (+2), 100–149 (+1), ≥150 (±0); AST (IU/L), <40 (±0), 40–79 (+1), ≥80 (+2); and ALT (IU/L), <40 (±0), 40–79 (+1), ≥80 (+2). Using a cut-off of ≥2, the algorithm had a sensitivity of 79% and specificity of 87% to identify treatment-eligible individuals in the validation dataset. Interpretation By using platelet counts, AST, and ALT, we can identify the majority of HBV-infected individuals in need of AVT. This implies that clinical staging for HBV can be decentralized to district hospital levels in sub-Saharan Africa. Funding None
【저자키워드】 sub-Saharan Africa, resource-limited settings, Hepatitis B virus, Treatment eligibility,