Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02344498
Enrollment
7350
Registered
2015-01-26
Start date
2015-01-31
Completion date
2026-12-31
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

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

DRUGTenofovir disoproxil

Sponsors

Addis Ababa University
CollaboratorOTHER
The Research Council of Norway
CollaboratorOTHER
University of Agder
CollaboratorOTHER
South-Eastern Norway Regional Health Authority, Norway
CollaboratorUNKNOWN
St. Paul's Hospital Millennium Medical College, Ethiopia
CollaboratorOTHER
Haramaya University,Ethiopia
CollaboratorUNKNOWN
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Death, HCC or decompensated cirrhosis3 yearsPatients 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

MeasureTime frameDescription
Viral suppression and genotypic resistance3 yearsProportion of patients with viral load suppression and absence of resistance after \>1 year of antiviral treatment.
Regression of liver inflammation/fibrosis3 yearsProportion of patients with normalization of ALT and improvement of liver stiffness (by transient elastography)
Adherence to therapy3 yearsProportion of patients with \>95% adherence measured by pill count and visual analogue scale

Other

MeasureTime frameDescription
Sensitivity and specificity of HBsAg rapid tests1 yearSensitivity and specificity of commonly used HBsAg rapid tests compared to a gold standard ELISA method

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026