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

• ClinicalTrials.gov Identifier: NCT02344498
• Recruitment Status: Active, not recruiting
• First Posted: January 26, 2015
• Last Update Posted: September 18, 2020
• Sponsor: Oslo University Hospital
• Collaborators: Addis Ababa University; The Research Council of Norway; University of Agder; South-Eastern Norway Regional Health Authority, Norway; St. Paul's Hospital Millennium Medical College, Ethiopia; Haramaya University,Ethiopia
• Information provided by (Responsible Party): Asgeir Johannessen, Oslo University Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Hepatitis B	Drug: Tenofovir disoproxil

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1350 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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 2022
• Estimated Study Completion Date: December 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Urban; HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.	Drug: Tenofovir disoproxil
Rural; HBV patients in Harar. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.	Drug: Tenofovir disoproxil

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. Regression of liver inflammation/fibrosis [ Time Frame: 3 years ]
   Proportion of patients with normalization of ALT and improvement of liver stiffness (by transient elastography)
3. Adherence to therapy [ Time Frame: 3 years ]
   Proportion of patients with >95% adherence measured by pill count and visual analogue scale

Other Outcome Measures:

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All adults with a positive HBsAg rapid test are eligible for inclusion.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

Ethiopia

St Paul Hospital Millennium Medical College

Addis Abeba, Ethiopia

Sponsors and Collaborators

Oslo University Hospital

Addis Ababa University

The Research Council of Norway

University of Agder

South-Eastern Norway Regional Health Authority, Norway

St. Paul's Hospital Millennium Medical College, Ethiopia

Haramaya University,Ethiopia

Investigators

• Principal Investigator: Asgeir Johannessen, MD PhD; Oslo University Hospital
• Principal Investigator: Nega Berhe, MD PhD; Addis Abeba University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

Aberra H, Gordien E, Desalegn H, Berhe N, Medhin G, Mekasha B, Gundersen SG, Gerber A, Stene-Johansen K, Øverbø 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.

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.

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.

• Responsible Party: Asgeir Johannessen, Researcher / project manager, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT02344498
• Other Study ID Numbers: 2014/1146
• First Posted: January 26, 2015
• Last Update Posted: September 18, 2020
• Last Verified: September 2020

Keywords provided by Asgeir Johannessen, Oslo University Hospital:

Liver cirrhosis; Antiviral agents; Liver diseases

Additional relevant MeSH terms:

Hepatitis A; Hepatitis B; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepadnaviridae Infections; DNA Virus Infections; Tenofovir; Antiviral Agents; Anti-Infective Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Retroviral Agents; Anti-HIV Agents