Evidence map›Paper›PMID 30554571›Full record

Trial reportBMC medicine2018

Treatment of chronic hepatitis B in sub-Saharan Africa: 1-year results of a pilot program in Ethiopia.

Hailemichael Desalegn, Hanna Aberra, Nega Berhe, Bitsatab Mekasha, Kathrine Stene-Johansen, Henrik Krarup, Andre Puntervold Pereira, Svein Gunnar Gundersen, Asgeir Johannessen

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in BMC medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02344498 (Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02344498 active not recruitingnot on this map

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

TypeobservationalSponsorOslo University HospitalRan2015 to 2026Enrolled7,350ConditionsHepatitis BArmsTenofovir disoproxil
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Hailemichael DesalegnMedical Department, St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia.
Hanna AberraMedical Department, St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia.
Nega BerheAklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia.
Bitsatab MekashaMedical Department, St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia.
Kathrine Stene-JohansenDepartment of Molecular Biology, Norwegian Institute of Public Health, Oslo, Norway.
Henrik KrarupSection of Molecular Diagnostics, Aalborg University Hospital, Aalborg, Denmark.
Andre Puntervold PereiraFaculty of Medicine, University of Oslo, Oslo, Norway.
Svein Gunnar GundersenResearch Unit, Sørlandet Hospital HF, Kristiansand, Norway.
Asgeir JohannessenCentre for Imported and Tropical Diseases, Oslo University Hospital, Ullevål, PO Box 4956 Nydalen, 0424, Oslo, Norway. johannessen.asgeir@gmail.com.ORCID 0000-0001-5966-7166

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe World Health Organization has set an ambitious goal of eliminating viral hepatitis as a major public health threat by 2030. However, in sub-Saharan Africa, antiviral treatment of chronic hepatitis B (CHB) is virtually unavailable. Herein, we present the 1-year results of a pilot CHB treatment program in Ethiopia.

methodsAt a public hospital in Addis Ababa, CHB patients were treated with tenofovir disoproxil fumarate based on simplified eligibility criteria. Baseline assessment included liver function tests, viral markers, and transient elastography (Fibroscan). Changes in laboratory markers were analyzed using Wilcoxon signed-rank tests. Adherence to therapy was measured by pharmacy refill data.

resultsOut of 1303 patients, 328 (25.2%) fulfilled the treatment criteria and 254 (19.5%) had started tenofovir disoproxil fumarate therapy prior to September 1, 2016. Of the patients who started therapy, 30 (11.8%) died within the first year of follow-up (28 of whom had decompensated cirrhosis), 9 (3.5%) self-stopped treatment, 7 (2.8%) were lost to follow-up, and 4 (1.6%) were transferred out. In patients who completed 12 months of treatment, the median Fibroscan value declined from 12.8 to 10.4 kPa (p < 0.001), 172 of 202 (85.1%) patients with available pharmacy refill data had taken ≥ 95% of their tablets, and 161 of 189 (85.2%) patients with viral load results had suppressed viremia. Virologic failure (≥ 69 IU/mL) at 12 months was associated with high baseline HBV viral load (> 1,000,000 IU/mL; adjusted OR 2.41; 95% CI 1.04-5.55) and suboptimal adherence (< 95%; adjusted OR 3.43, 95% CI 1.33-8.88).

conclusionsThis pilot program demonstrated that antiviral therapy of CHB can be realized in Ethiopia with good clinical and virologic response. Early mortality was high in patients with decompensated cirrhosis, underscoring the need for earlier detection of hepatitis B virus infection and timely initiation of treatment, prior to the development of irreversible complications, in sub-Saharan Africa.

trial registrationNCT02344498 (ClinicalTrials.gov identifier). Registered 16 January 2015.

Indexed as

AdolescentAdultAntiviral AgentsBiomarkersEthiopiaFemaleFollow-Up StudiesHepatitis B, ChronicHumansLiver CirrhosisMaleMiddle AgedPilot ProjectsTenofovirTreatment Adherence and ComplianceTreatment OutcomeAntiviral AgentsBiomarkersTenofovirAntiviral therapyEpidemiologyResource-limited settingsViral hepatitis

Identifiers

PMID30554571
PMCPMC6296040

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.