Five-year results of a treatment program for chronic hepatitis B in Ethiopia.
Antiviral treatment
Hepatitis B virus
Longitudinal cohort study
Resource-limited settings
Survival analysis
Journal
BMC medicine
ISSN: 1741-7015
Titre abrégé: BMC Med
Pays: England
ID NLM: 101190723
Informations de publication
Date de publication:
29 09 2023
29 09 2023
Historique:
received:
15
03
2023
accepted:
15
09
2023
medline:
2
10
2023
pubmed:
30
9
2023
entrez:
29
9
2023
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
TRIAL REGISTRATION
The study was registered at ClinicalTrials.gov (NCT02344498) on January 26, 2015.
Identifiants
pubmed: 37775742
doi: 10.1186/s12916-023-03082-4
pii: 10.1186/s12916-023-03082-4
pmc: PMC10543851
doi:
Substances chimiques
Tenofovir
99YXE507IL
Antiviral Agents
0
Banques de données
ClinicalTrials.gov
['NCT02344498']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
373Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
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