Hepatitis B
Conditions
Keywords
Liver cirrhosis, Antiviral agents, Liver diseases
Brief summary
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
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Consenting adults (≥18 years) residing in Ethiopia who are HBsAg positive
Exclusion criteria
* Children \<18 years, other terminal disease (cancer etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death, HCC or decompensated cirrhosis | 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral suppression and genotypic resistance | 3 years | Proportion of patients with viral load suppression and absence of resistance after \>1 year of antiviral treatment. |
| Regression of liver inflammation/fibrosis | 3 years | Proportion of patients with normalization of ALT and improvement of liver stiffness (by transient elastography) |
| Adherence to therapy | 3 years | Proportion of patients with \>95% adherence measured by pill count and visual analogue scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of HBsAg rapid tests | 1 year | Sensitivity and specificity of commonly used HBsAg rapid tests compared to a gold standard ELISA method |
Countries
Ethiopia