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J Hepatol. 2018 Oct;69(4):776-784. doi: 10.1016/j.jhep.2018.05.024. Epub 2018 Jul 1.

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

Author information

1
Unité d'Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, France. Electronic address: yusuke.shimakawa@gmail.com.
2
The Gambia Hepatitis Intervention Study, IARC, c/o MRC Unit, Fajara, The Gambia.
3
Medical Research Council (MRC) Unit, The Gambia at the London School of Hygiene and Tropical Medicine, The Gambia; Department of Surgery and Cancer, Liver Unit, Imperial College London, UK.
4
Unité d'Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, France; Unité d'Épidémiologie des Maladies Infectieuses, Institut Pasteur de Dakar, Dakar, Senegal.
5
Département d'Hépato-gastroentérologie, Hôpital Principal, Dakar, Senegal.
6
Hôpital Tenon, Paris, France.
7
Département d'Hépato-gastroentérologie, Centre Hospitalier Universitaire Yalgado Ouédraogo, Ouagadougou, Burkina Faso.
8
Université Grenoble Alpes, Grenoble, France.
9
Infectious Disease Department, St Antoine Hospital, AP-HP, Paris, France.
10
Center for Infectiology, Berlin, Germany.
11
Center for Infectiology, Berlin, Germany; Charité - Universitätsmedizin Berlin, Berlin, Germany.
12
National Public Health Laboratory, Banjul, The Gambia.
13
Medical Research Council (MRC) Unit, The Gambia at the London School of Hygiene and Tropical Medicine, The Gambia.
14
Department of Surgery and Cancer, Liver Unit, Imperial College London, UK.
15
INSERM U1052, CNRS UMR5286, Centre de Recherche en Cancérologie, Université Claude Bernard, Lyon, France.
16
International Agency for Research on Cancer (IARC), Lyon, France.
17
Department of Surgery and Cancer, Liver Unit, Imperial College London, UK. Electronic address: m.lemoine@imperial.ac.uk.

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 not 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 based on alanine aminotransferase (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, constituting a simple score (treatment eligibility in Africa for the hepatitis B virus: TREAT-B). The score demonstrated a high area under the receiver operating characteristic curve (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 World Health Organization criteria based on the aspartate aminotransferase-to-platelet ratio index (APRI) and ALT were 90% and 40%, respectively.

CONCLUSIONS:

A simple score based on HBeAg and ALT had a high diagnostic accuracy for the selection of patients for HBV treatment. This score could be useful in African settings.

LAY SUMMARY:

Limited access to the diagnostic tools used to assess treatment eligibility (liver biopsy/Fibroscan/hepatitis B virus DNA) has been an obstacle to the scale up of hepatitis B treatment programs in low- and middle-income countries. Using the data from African patients with chronic HBV infection, we developed and validated a new simple diagnostic score for treatment eligibility, which only consists of hepatitis B virus e antigen and alanine aminotransferase level. The diagnostic accuracy of the score for selecting patients for HBV treatment was high and could be useful in African settings.

KEYWORDS:

Africa; Diagnostic score; Elimination; Hepatitis B; Patient care management; Sensitivity and specificity; Validation studies

PMID:
30104154
DOI:
10.1016/j.jhep.2018.05.024
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