Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: Tenofovir disoproxil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting adults (≥18 years) residing in Ethiopia who are HBsAg positive Exclusion Criteria: Children <18 years, other terminal disease (cancer etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Urban<br>HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD. | Drug: Tenofovir disoproxil<br> <br> |
| Rural<br>HBV patients in Harar. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD. | Drug: Tenofovir disoproxil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver cirrhosis, Antiviral agents, Liver diseases