Clinical trial NCT02344498: Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa
Official title: Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatitis B
Keywords: Liver cirrhosis
Antiviral agents
Liver diseases
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Addis Ababa University
name: The Research Council of Norway
name: University of Agder
name: South-Eastern Norway Regional Health Authority, Norway
name: St. Paul's Hospital Millennium Medical College, Ethiopia
name: Haramaya University,Ethiopia
First posted: 2015-01-26
Enrollment: 7350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults with a positive HBsAg rapid test are eligible for inclusion.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Death, HCC or decompensated cirrhosis
timeFrame: 3 years
Secondary outcomes:
measure: Viral suppression and genotypic resistance
timeFrame: 3 years
measure: Regression of liver inflammation/fibrosis
timeFrame: 3 years
measure: Adherence to therapy
timeFrame: 3 years
Other outcomes:
measure: Sensitivity and specificity of HBsAg rapid tests
timeFrame: 1 year
Locations:
city: Addis Abeba
country: Ethiopia
facility: St Paul Hospital Millennium Medical College
Study officials:
affiliation: Oslo University Hospital
name: Asgeir Johannessen, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Addis Abeba University
name: Nega Berhe, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Desalegn H, Aberra H, Berhe N, Medhin G, Mekasha B, Gundersen SG, Johannessen A. Predictors of mortality in patients under treatment for chronic hepatitis B in Ethiopia: a prospective cohort study. BMC Gastroenterol. 2019 May 15;19(1):74. doi: 10.1186/s12876-019-0993-1.
citation: Aberra H, Desalegn H, Berhe N, Mekasha B, Medhin G, Gundersen SG, Johannessen A. The WHO guidelines for chronic hepatitis B fail to detect half of the patients in need of treatment in Ethiopia. J Hepatol. 2019 Jun;70(6):1065-1071. doi: 10.1016/j.jhep.2019.01.037. Epub 2019 Mar 28.
citation: Desalegn H, Aberra H, Berhe N, Mekasha B, Stene-Johansen K, Krarup H, Pereira AP, Gundersen SG, Johannessen A. Treatment of chronic hepatitis B in sub-Saharan Africa: 1-year results of a pilot program in Ethiopia. BMC Med. 2018 Dec 17;16(1):234. doi: 10.1186/s12916-018-1229-x.
citation: Aberra H, Gordien E, Desalegn H, Berhe N, Medhin G, Mekasha B, Gundersen SG, Gerber A, Stene-Johansen K, Overbo J, Johannessen A. Hepatitis delta virus infection in a large cohort of chronic hepatitis B patients in Ethiopia. Liver Int. 2018 Jun;38(6):1000-1009. doi: 10.1111/liv.13607. Epub 2017 Oct 20.
citation: Aberra H, Desalegn H, Berhe N, Medhin G, Stene-Johansen K, Gundersen SG, Johannessen A. Early experiences from one of the first treatment programs for chronic hepatitis B in sub-Saharan Africa. BMC Infect Dis. 2017 Jun 19;17(1):438. doi: 10.1186/s12879-017-2549-8.
citation: Desalegn H, Aberra H, Berhe N, Gundersen SG, Johannessen A. Are non-invasive fibrosis markers for chronic hepatitis B reliable in sub-Saharan Africa? Liver Int. 2017 Oct;37(10):1461-1467. doi: 10.1111/liv.13393. Epub 2017 Mar 23.