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| Name | Class |
|---|---|
| Addis Ababa University | OTHER |
| The Research Council of Norway | OTHER |
| University of Agder | OTHER |
| South-Eastern Norway Regional Health Authority |
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Viral hepatitis kills nearly one million people each year, even though effective treatment exists. The aim of this study is to establish a treatment protocol for hepatitis B, which is simple and cheap enough to be implemented in resource-limited settings.
Chronic viral hepatitis is a major health problem globally. Each year nearly one million deaths are attributable to either hepatitis B or C. In Ethiopia 5-10% of the general population are infected with hepatitis B. Oral antiviral treatment of hepatitis B exists, but high costs and advanced laboratory requirements have been barriers to offer such treatment in resource-limited settings, resembling the situation in treatment of HIV/AIDS a decade ago.
The present study will investigate a simplified approach to hepatitis B treatment in resource-limited settings, inspired by the recent success of HIV treatment in such settings. The critical research question is how to identify patients with expected benefit of treatment in the absence of advanced laboratory support. A WHO expert panel recently suggested treatment criteria for use in settings without advanced laboratory facilities, but these criteria have not yet been tested out in real life. The present study will build on and develop the WHO approach to treatment of hepatitis B, aiming to develop a treatment protocol that can be feasible in other resource-limited countries. The potential public health benefit for poor people in low- and middle-income countries is substantial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urban | HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD. |
| |
| Rural | HBV patients in Adama, Afar, Jigjiga and Jimma. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir disoproxil | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death, HCC or decompensated cirrhosis | Patients will be reviewed every 3-6 months with liver function tests and/or ultrasound to detect the proportion of participants who develop liver decompensation or hepatocellular carcinoma. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Viral suppression and genotypic resistance | Proportion of patients with viral load suppression and absence of resistance after >1 year of antiviral treatment. | 3 years |
| Regression of liver inflammation/fibrosis |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of HBsAg rapid tests | Sensitivity and specificity of commonly used HBsAg rapid tests compared to a gold standard ELISA method | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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All adults with a positive HBsAg rapid test are eligible for inclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Asgeir Johannessen, MD PhD | Oslo University Hospital | Principal Investigator |
| Nega Berhe, MD PhD | Addis Abeba University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Paul Hospital Millennium Medical College | Addis Ababa | Addis Ababa | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41109262 | Derived | Rossvoll L, Desalegn H, Gudissa FG, Birhanu D, Hussen A, Cheneke W, Jeylan A, Debela EA, Yusuf M, Sugule A, Berhanu N, Gudina EK, Orlien SM, Stockdale AJ, Berhe N, Johannessen A. Treatment of chronic hepatitis B in Ethiopia: 1-year results from a real-life, multicentre, prospective cohort study. Lancet Glob Health. 2025 Nov;13(11):e1914-e1923. doi: 10.1016/S2214-109X(25)00309-2. | |
| 39774109 |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D008103 | Liver Cirrhosis |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| OTHER |
| St. Paul's Hospital Millennium Medical College, Ethiopia | OTHER |
| Haramaya University,Ethiopia | UNKNOWN |
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Proportion of patients with normalization of ALT and improvement of liver stiffness (by transient elastography)
| 3 years |
| Adherence to therapy | Proportion of patients with >95% adherence measured by pill count and visual analogue scale | 3 years |
| Derived |
| Desalegn H, Yang X, Yen YS, Berhe N, Kenney B, Siwo GH, Tang W, Zhu J, Waljee AK, Johannessen A. Machine-learning methodologies to predict disease progression in chronic hepatitis B in Africa. Hepatol Commun. 2024 Nov 15;8(12):e0584. doi: 10.1097/HC9.0000000000000584. eCollection 2024 Dec 1. |
| 37775742 | Derived | Desalegn H, Orlien SMS, Aberra H, Mamo E, Grude S, Hommersand K, Berhe N, Gundersen SG, Johannessen A. Five-year results of a treatment program for chronic hepatitis B in Ethiopia. BMC Med. 2023 Sep 29;21(1):373. doi: 10.1186/s12916-023-03082-4. |
| 31092203 | Derived | Desalegn H, Aberra H, Berhe N, Medhin G, Mekasha B, Gundersen SG, Johannessen A. Predictors of mortality in patients under treatment for chronic hepatitis B in Ethiopia: a prospective cohort study. BMC Gastroenterol. 2019 May 15;19(1):74. doi: 10.1186/s12876-019-0993-1. |
| 30929749 | Derived | Aberra H, Desalegn H, Berhe N, Mekasha B, Medhin G, Gundersen SG, Johannessen A. The WHO guidelines for chronic hepatitis B fail to detect half of the patients in need of treatment in Ethiopia. J Hepatol. 2019 Jun;70(6):1065-1071. doi: 10.1016/j.jhep.2019.01.037. Epub 2019 Mar 28. |
| 30554571 | Derived | Desalegn H, Aberra H, Berhe N, Mekasha B, Stene-Johansen K, Krarup H, Pereira AP, Gundersen SG, Johannessen A. Treatment of chronic hepatitis B in sub-Saharan Africa: 1-year results of a pilot program in Ethiopia. BMC Med. 2018 Dec 17;16(1):234. doi: 10.1186/s12916-018-1229-x. |
| 28980394 | Derived | Aberra H, Gordien E, Desalegn H, Berhe N, Medhin G, Mekasha B, Gundersen SG, Gerber A, Stene-Johansen K, Overbo J, Johannessen A. Hepatitis delta virus infection in a large cohort of chronic hepatitis B patients in Ethiopia. Liver Int. 2018 Jun;38(6):1000-1009. doi: 10.1111/liv.13607. Epub 2017 Oct 20. |
| 28629395 | Derived | Aberra H, Desalegn H, Berhe N, Medhin G, Stene-Johansen K, Gundersen SG, Johannessen A. Early experiences from one of the first treatment programs for chronic hepatitis B in sub-Saharan Africa. BMC Infect Dis. 2017 Jun 19;17(1):438. doi: 10.1186/s12879-017-2549-8. |
| 28222249 | Derived | Desalegn H, Aberra H, Berhe N, Gundersen SG, Johannessen A. Are non-invasive fibrosis markers for chronic hepatitis B reliable in sub-Saharan Africa? Liver Int. 2017 Oct;37(10):1461-1467. doi: 10.1111/liv.13393. Epub 2017 Mar 23. |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |