Evidence map›Paper›PMID 30073087›Full record

ArticlePharmacology research & perspectives2018

Serious hepatotoxicity following use of isoniazid preventive therapy in HIV patients in Eritrea.

Mulugeta Russom, Merhawi Debesai, Mehari Zeregabr, Araia Berhane, Theodros Tekeste, Teklezghi Teklesenbet

Open access · goldAbstract read
In one paragraph

Article in Pharmacology research & perspectives, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 12% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Assessing the protective effect ofAfrican health sciences · 2022
    Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Signatures in drug-induced liver injury.Current opinion in gastroenterology · 2020
    Review
  14. Article
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

6 authors at 3 institutions in 2 countries.

Mulugeta RussomEritrean Pharmacovigilance Centre Asmara Eritrea.ORCID 0000-0003-1939-5842
Merhawi DebesaiEritrean Pharmacovigilance Centre Asmara Eritrea.
Mehari ZeregabrEritrean Pharmacovigilance Centre Asmara Eritrea.
Araia BerhaneCommunicable Disease Control Division Asmara Eritrea.
Theodros TekesteDisgsa Community Hospital Segeneity Eritrea.
Teklezghi TeklesenbetKeren Zonal Referral Hospital Keren Eritrea.
University of Asmara · ERDefense Information Systems Agency · USMichigan Surgical Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

WHO information note indicates that isoniazid preventive therapy (IPT) is generally safe with little risk of hepatotoxicity. However, when the policy of IPT for HIV patients was introduced in Eritrea, frequent IPT-associated hepatotoxicity and fatality have been reported to the Pharmacovigilance Centre. The aim of the study is to assess the causal association of IPT and hepatotoxicity and identify possible risk factors in patients on Highly Active Anti-retroviral Therapy (HAART). This is a case series assessment of spontaneously reported cases to the Eritrean Pharmacovigilance Centre. Data extracted from VigiFlow (reported between 2014 and 2016) were exported to excel spread sheet for descriptive and qualitative analysis. Naranjo probability scale and Austin Bradford-Hill criteria were used to assess causality. The P-Method was used to assess preventability. A total of 31 of cases of hepatotoxicity related to IPT were retrieved. Majority (80.6%) of the cases were marked as "serious" due to life-threatening situation (n = 15), hospitalization (n = 6), and death (n = 4). Baseline liver function test was normal in 61.3% and hepatitis B and C infections were ruled out in 77.4%. IPT was discontinued in 26 cases and reaction abated in 22 of them. Causality assessment using Austin Bradford-Hill criteria found that the association was strong, consistent and specific with a plausible temporal relationship and biological mechanism. IPT-associated hepatotoxicity that led to treatment interruption and death was observed in patients on HAART in Eritrea. Hence, close laboratory monitoring of patients is recommended to minimize the risk.

Indexed as

Antiretroviral Therapy, Highly ActiveChemical and Drug Induced Liver InjuryAdultAgedAIDS-Related Opportunistic InfectionsAntitubercular AgentsEritreaFemaleHIV InfectionsHumansIsoniazidMaleMiddle AgedRisk FactorsTuberculosisAntitubercular AgentsIsoniazidEritreahepatotoxicityisoniazid preventive therapypatients on HAART

Identifiers

PMID30073087
PMCPMC6066797
OpenAlexW2886013930

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.