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

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Hepatitis B

Treatments: Drug: Tenofovir disoproxil

Study type: Observational

Funder types: Other

Identifiers

NCT02344498

2014/1146

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consenting adults (≥18 years) residing in Ethiopia who are HBsAg positive

Exclusion criteria

• Children <18 years, other terminal disease (cancer etc.)

Trial design

7,350 participants in 2 patient groups

Urban

Description:

HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.

Treatment:

Drug: Tenofovir disoproxil

Rural

Description:

HBV patients in Adama, Afar, Jigjiga and Jimma. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.

Treatment:

Drug: Tenofovir disoproxil