Development of a simple score based on HBeAg and ALT for selecting patients for HBV treatment in Africa

Abstract

Background & Aims To eliminate hepatitis B virus (HBV) infection, it is essential to scale up antiviral treatment through decentralized services. However, access to the conventional tools to assess treatment eligibility (liver biopsy/Fibroscan/HBV DNA) is limited and non-affordable in resource-limited countries. We developed and validated a simple score to easily identify patients in need of HBV treatment in Africa. Methods As a reference, we used treatment eligibility determined by the European Association for the Study of the Liver (EASL) based on alanine transaminase (ALT), liver histology and/or Fibroscan and HBV DNA. We derived a score indicating treatment eligibility by a stepwise logistic regression using a cohort of chronic HBV infection in The Gambia (n=804). We subsequently validated the score in an external cohort of HBV-infected Africans from Senegal, Burkina Faso, and Europe (n=327). Results Out of several parameters, two remained in the final model, namely HBV e antigen (HBeAg) and ALT level, and constituted a simple score (TREAT-B). The score demonstrated a high area under the receiver operating characteristic (0.85, 95% CI: 0.79-0.91) in the validation set. The score of 2 and above (HBeAg-positive and ALT≥20 U/L or HBeAg-negative and ALT≥40 U/L) had a sensitivity and specificity for treatment eligibility of 85% and 77%, respectively. The sensitivity and specificity of the WHO criteria based on APRI and ALT were 90% and 40%, respectively. Conclusions The diagnostic accuracy of a simple score based on HBeAg and ALT for selecting patients for HBV treatment is high and could be useful in African settings.