Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa
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|ClinicalTrials.gov Identifier: NCT02344498|
Recruitment Status : Active, not recruiting
First Posted : January 26, 2015
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment|
|Hepatitis B||Drug: Tenofovir disoproxil|
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.
|Study Type :||Observational|
|Actual Enrollment :||1350 participants|
|Official Title:||Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa|
|Actual Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
Drug: Tenofovir disoproxil
HBV patients in Harar. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.
Drug: Tenofovir disoproxil
- Death, HCC or decompensated cirrhosis [ Time Frame: 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.
- Viral suppression and genotypic resistance [ Time Frame: 3 years ]Proportion of patients with viral load suppression and absence of resistance after >1 year of antiviral treatment.
- Regression of liver inflammation/fibrosis [ Time Frame: 3 years ]Proportion of patients with normalization of ALT and improvement of liver stiffness (by transient elastography)
- Adherence to therapy [ Time Frame: 3 years ]Proportion of patients with >95% adherence measured by pill count and visual analogue scale
- Sensitivity and specificity of HBsAg rapid tests [ Time Frame: 1 year ]Sensitivity and specificity of commonly used HBsAg rapid tests compared to a gold standard ELISA method
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344498
|St Paul Hospital Millennium Medical College|
|Addis Abeba, Ethiopia|
|Principal Investigator:||Asgeir Johannessen, MD PhD||Oslo University Hospital|
|Principal Investigator:||Nega Berhe, MD PhD||Addis Abeba University|