The WHO guidelines for chronic hepatitis B fail to detect half of the patients in need of treatment in Ethiopia

Abstract

Background & aims: In 2015, the World Health Organization (WHO) issued guidelines for the management of chronic hepatitis B (CHB) in low- and middle-income countries, but little is known about the applicability of the WHO treatment criteria in sub-Saharan Africa. The aim of this study was to evaluate the diagnostic performance of the WHO guidelines in a large CHB cohort in Ethiopia.

Methods: Treatment-naïve adults who attended a public CHB clinic in Addis Ababa were included in this analysis. All patients underwent a standardized evaluation at recruitment, including blood tests and transient elastography (Fibroscan®). A Fibroscan result >7.9 kPa was used to define significant fibrosis and >9.9 kPa to define cirrhosis. Treatment eligibility was assessed using the most recent guidelines from the European Association for the Study of the Liver (EASL) as the 'gold standard'.

Results: Out of 1,190 patients with CHB, 300 (25.2%) were eligible for treatment based on the EASL 2017 guidelines and 182 (15.3%) based on the WHO 2015 guidelines. The sensitivity and specificity of the WHO criteria were 49.0 and 96.1%, respectively. Most patients (94 of 182; 51.6%) who fulfilled the WHO criteria had decompensated cirrhosis and might have a dismal prognosis even with therapy. Only 41 of 115 patients (35.7%) with compensated cirrhosis, who are likely to benefit the most from therapy, were eligible for treatment based on the WHO criteria.

Conclusions: The WHO guidelines for CHB failed to detect half of the patients in need of treatment in Ethiopia, implying the need for a revision of the WHO treatment criteria.

Lay summary: Antiviral therapy prevents disease progression and death in patients with chronic hepatitis B (CHB), but the identification of patients in need of treatment is a challenge in low- and middle-income countries. The World Health Organization (WHO) has suggested treatment eligibility criteria for use in such settings, but in our study the WHO criteria detected less than half of those in need of therapy in a large Ethiopian cohort of 1,190 patients with CHB. Our findings suggest that the WHO criteria might be unsuitable in sub-Saharan Africa.

Trial registration number: NCT02344498 (ClinicalTrials.gov identifier). Registered 16 January 2015.

Keywords: Antiviral therapy; Resource-limited settings; Treatment guidelines; Validation; Viral hepatitis.