Treatment of chronic hepatitis B in Ethiopia: 1-year results from a real-life, multicentre, prospective cohort study.

Abstract

BACKGROUND In the global efforts to combat chronic hepatitis B virus (HBV) infection, the African continent is falling behind. Simplified treatment guidelines are recommended by WHO in low-income and middle-income countries, but it is unclear how this approach works in real life. We aimed to address this knowledge gap using a simplified treatment programme in Ethiopia. METHODS We did a prospective cohort study in four public hospitals in Ethiopia. We enrolled HIV-negative adults (age ≥18 years) with chronic HBV infection and applied simplified treatment criteria on the basis of clinical assessment, aspartate aminotransferase-to-platelet ratio index (APRI), alanine aminotransferase, and point-of-care HBV DNA. The primary endpoint was 1-year treatment outcome (active in care, dead, or lost to follow-up), and secondary endpoints were virological and biochemical treatment response. We used Cox proportional hazards regression models to identify predictors of death and logistic regression models to explore associating factors with decompensated cirrhosis. This study is registered with ClinicalTrials.gov, NCT02344498. FINDINGS Between Dec 8, 2021, and Dec 31, 2023, we enrolled 6010 participants (2953 [49·1%] female and 3057 [50·9%] male; median age 30 years [IQR 25-38]), of whom 1672 (27·8%) were eligible for treatment. 1138 (18·9%) started tenofovir disoproxil fumarate treatment before July 1, 2023, and were included in the 1-year analysis. 532 (46·7%) participants were active in care after 1 year, 58 (5·1%) died, and 508 (44·6%) were lost to follow-up. Of the participants active in care after 1 year, 321 (78·3%) of 410 had virological suppression (HBV DNA ≤10 IU/mL) and 289 (67·5%) of 428 had normal ALT (≤40 U/L). Independent predictors of death were decompensated cirrhosis (adjusted hazard ratio [HR] 8·74 [95% CI 5·01-15·27]) and age (per 1-year increment; adjusted HR 1·03 [1·01-1·05]). Decompensated cirrhosis was associated with male sex (adjusted odds ratio [OR] 1·68 [95% CI 1·17-2·40]), increasing age (per 1-year increment; adjusted OR 1·02 [1·01-1·03]), regular khat use (adjusted OR 1·54 [1·11-2·12]), and HBV DNA concentration greater than 200 000 IU/mL (adjusted OR 1·52 [1·10-2·11]). INTERPRETATION About half of the participants who initiated HBV treatment were still active in care after 1 year, and most of whom had virological and biochemical response to treatment. However, the high proportion lost to follow-up underscores the need for better strategies and tools to improve retention in HBV care. FUNDING The South-Eastern Norway Regional Health Authority and the John C Martin Foundation.