NCT02344498

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 7,350 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	Tenofovir disoproxil

Timeline

• Start date: 2015-01-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2015-01-26
• Last updated: 2024-11-15

Locations

1 site across 1 country: Ethiopia