Five-year results of a treatment program for chronic hepatitis B in Ethiopia.

In sub-Saharan Africa, less than 1% of treatment-eligible chronic hepatitis B (CHB) patients receive antiviral therapy. Experiences from local CHB programs are needed to inform treatment guidelines and policies on the continent. Here, we present 5-year results from one of the first large-scale CHB treatment programs in sub-Saharan Africa. Adults with CHB were enrolled in a pilot treatment program in Addis Ababa, Ethiopia, in 2015. Liver enzymes, viral markers, and transient elastography were assessed at baseline and thereafter at 6-month intervals. Tenofovir disoproxil fumarate was initiated based on the European Association for the Study of the Liver (EASL) criteria, with some modifications. Survival analysis was performed using the Kaplan-Meier method. In total, 1303 patients were included in the program, of whom 291 (22.3%) started antiviral therapy within the initial 5 years of follow-up. Among patients on treatment, estimated 5-year hepatocellular carcinoma-free survival was 99.0% in patients without cirrhosis at baseline, compared to 88.8% in patients with compensated cirrhosis, and 54.2% in patients with decompensated cirrhosis (p < 0.001). The risk of death was significantly higher in patients with decompensated cirrhosis at baseline (adjusted hazard ratio 44.6, 95% confidence interval 6.1-328.1) and in patients older than 40 years (adjusted hazard ratio 3.7, 95% confidence interval 1.6-8.5). Liver stiffness declined significantly after treatment initiation; the median change from baseline after 1, 3, and 5 years of treatment was - 4.0 kPa, - 5.2 kPa, and - 5.6 kPa, respectively. This pilot program demonstrates the long-term benefits of CHB therapy in a resource-limited setting. The high mortality in patients with cirrhosis underscores the need for earlier detection of CHB and timely initiation of antiviral treatment in sub-Saharan Africa. The study was registered at ClinicalTrials.gov (NCT02344498) on January 26, 2015.

Desalegn H ，Orlien SMS ，Aberra H ，Mamo E ，Grude S ，Hommersand K ，Berhe N ，Gundersen SG ，Johannessen A ... -  《BMC Medicine》

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

Desalegn H ，Aberra H ，Berhe N ，Mekasha B ，Stene-Johansen K ，Krarup H ，Pereira AP ，Gundersen SG ，Johannessen A ... -  《BMC Medicine》

Early experiences from one of the first treatment programs for chronic hepatitis B in sub-Saharan Africa.

Aberra H ，Desalegn H ，Berhe N ，Medhin G ，Stene-Johansen K ，Gundersen SG ，Johannessen A ... -  《BMC INFECTIOUS DISEASES》

Predictors of mortality in patients under treatment for chronic hepatitis B in Ethiopia: a prospective cohort study.

Desalegn H ，Aberra H ，Berhe N ，Medhin G ，Mekasha B ，Gundersen SG ，Johannessen A ... -  《BMC GASTROENTEROLOGY》

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

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. 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'. 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. 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. 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. NCT02344498 (ClinicalTrials.gov identifier). Registered 16 January 2015.

Aberra H ，Desalegn H ，Berhe N ，Mekasha B ，Medhin G ，Gundersen SG ，Johannessen A ... -  《-》