Treatment of chronic hepatitis B in sub-Saharan Africa: 1-year results of a pilot program in Ethiopia

Hailemichael Desalegn,Nega Berhe,Kathrine Stene-Johansen,Hanna Aberra,Andre Puntervold Pereira,Svein Gunnar Gundersen,Henrik Krarup,Bitsatab Mekasha,Asgeir Johannessen

doi:10.1186/s12916-018-1229-x

Abstract

BackgroundThe World Health Organization has set an ambitious goal of eliminating viral hepatitis as a major public health threat by 2030. However, in sub-Saharan Africa, antiviral treatment of chronic hepatitis B (CHB) is virtually unavailable. Herein, we present the 1-year results of a pilot CHB treatment program in Ethiopia.MethodsAt a public hospital in Addis Ababa, CHB patients were treated with tenofovir disoproxil fumarate based on simplified eligibility criteria. Baseline assessment included liver function tests, viral markers, and transient elastography (Fibroscan). Changes in laboratory markers were analyzed using Wilcoxon signed-rank tests. Adherence to therapy was measured by pharmacy refill data.ResultsOut of 1303 patients, 328 (25.2%) fulfilled the treatment criteria and 254 (19.5%) had started tenofovir disoproxil fumarate therapy prior to September 1, 2016. Of the patients who started therapy, 30 (11.8%) died within the first year of follow-up (28 of whom had decompensated cirrhosis), 9 (3.5%) self-stopped treatment, 7 (2.8%) were lost to follow-up, and 4 (1.6%) were transferred out. In patients who completed 12 months of treatment, the median Fibroscan value declined from 12.8 to 10.4 kPa (p < 0.001), 172 of 202 (85.1%) patients with available pharmacy refill data had taken ≥ 95% of their tablets, and 161 of 189 (85.2%) patients with viral load results had suppressed viremia. Virologic failure (≥ 69 IU/mL) at 12 months was associated with high baseline HBV viral load (> 1,000,000 IU/mL; adjusted OR 2.41; 95% CI 1.04–5.55) and suboptimal adherence (< 95%; adjusted OR 3.43, 95% CI 1.33–8.88).ConclusionsThis pilot program demonstrated that antiviral therapy of CHB can be realized in Ethiopia with good clinical and virologic response. Early mortality was high in patients with decompensated cirrhosis, underscoring the need for earlier detection of hepatitis B virus infection and timely initiation of treatment, prior to the development of irreversible complications, in sub-Saharan Africa.Trial registrationNCT02344498 (ClinicalTrials.gov identifier). Registered 16 January 2015.

Highlights

The World Health Organization has set an ambitious goal of eliminating viral hepatitis as a major public health threat by 2030
This pilot program demonstrated that antiviral therapy of chronic hepatitis B (CHB) can be realized in Ethiopia with good clinical and virologic response
Mortality was high in patients with decompensated cirrhosis, underscoring the need for earlier detection of hepatitis B virus infection and timely initiation of treatment, prior to the development of irreversible complications, in sub-Saharan Africa

Summary

Introduction

The World Health Organization has set an ambitious goal of eliminating viral hepatitis as a major public health threat by 2030. In sub-Saharan Africa, antiviral treatment of chronic hepatitis B (CHB) is virtually unavailable. Chronic infection with hepatitis B virus (HBV) is a leading cause of cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC). 257 million people worldwide are living with chronic hepatitis B (CHB), and an estimated 887,000 deaths per year are attributable to HBV infection [1]. In 2015, viral hepatitis claimed more lives than human immunodeficiency virus (HIV) [3]. Long-term antiviral treatment has been shown to stop and even reverse liver fibrosis and prevent development of HCC [5, 6]. Hepatitis B surface antigen (HBsAg) loss is the optimal treatment endpoint, but is rarely achieved; most patients need long-term treatment to suppress viral replication and prevent hepatic complications [7]

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Results

Conclusion