Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 7,350
- 试验地点
- 1
- 主要终点
- Death, HCC or decompensated cirrhosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting adults (≥18 years) residing in Ethiopia who are HBsAg positive
排除标准
- •Children <18 years, other terminal disease (cancer etc.)
研究组 & 干预措施
Urban
HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
干预措施: Tenofovir disoproxil (Drug)
Rural
HBV patients in Adama, Afar, Jigjiga and Jimma. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
干预措施: Tenofovir disoproxil (Drug)
结局指标
主要结局
Death, HCC or decompensated cirrhosis
时间窗: 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.
次要结局
- Adherence to therapy(3 years)
- Viral suppression and genotypic resistance(3 years)
- Regression of liver inflammation/fibrosis(3 years)
研究者
Asgeir Johannessen
Researcher / project manager
Oslo University Hospital
