Evidence map›Paper›PMID 27769174›Full record

ArticleBMC infectious diseases2016

Severe adverse events during second-line tuberculosis treatment in the context of high HIV Co-infection in South Africa: a retrospective cohort study.

Kathryn Schnippel, Rebecca H Berhanu, Andrew Black, Cynthia Firnhaber, Norah Maitisa, Denise Evans, Edina Sinanovic

Abstract readMulticenter Study
In one paragraph

Article in BMC infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing 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.

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

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

  1. Pooled it
  2. Exploring HIV disease indicators at MDR-TB treatment initiation in South Africa.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2024
    Trial
  3. Article
  4. Observational
  5. Article
  6. Article
  7. Article
  8. Article
  9. Evaluation of drug-resistant tuberculosis treatment outcome in Limpopo province, South Africa.African journal of primary health care & family medicine · 2023
    Article
  10. Article
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  13. Article
  14. Review
  15. Article
  16. The Impact of Concurrent Antiretroviral Therapy and MDR-TB Treatment on Adverse Events.Journal of acquired immune deficiency syndromes (1999) · 2020
    Article
  17. Review
  18. Rates and risk factors for nephrotoxicity and ototoxicity among tuberculosis patients in Tbilisi, Georgia.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2019
    Article
  19. Article
  20. Observational
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

7 authors.

Kathryn SchnippelRight to Care, Johannesburg, South Africa. kschnipp@gmail.com.ORCID http://orcid.org/0000-0003-0757-4325
Rebecca H BerhanuRight to Care, Johannesburg, South Africa.
Andrew BlackWits Reproductive Health and HIV Research Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Cynthia FirnhaberRight to Care, Johannesburg, South Africa.
Norah MaitisaWits Reproductive Health and HIV Research Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Denise EvansHealth Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.
Edina SinanovicHealth Economics Unit, School of Family and Public Health, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccording to the World Health Organization, South Africa ranks as one of the highest burden of TB, TB/HIV co-infection, and drug-resistant TB (DR-TB) countries. DR-TB treatment is complicated to administer and relies on the use of multiple toxic drugs, with potential for severe adverse drug reactions. We report the occurrence of adverse events (AEs) during a standardised DR-TB treatment regimen at two outpatient, decentralized, public-sector sites in Johannesburg, South Africa.

methodsWe reviewed medical records of the six-month intensive treatment phase for rifampicin-resistant (RR) TB patients registered May 2012 - December 2014. Patients contributed follow-up time until death, loss from treatment, censoring (6 months) or data extraction. A standardized regimen of kanamycin, moxifloxacin, ethionamide, terizidone, and pyrazinamide was used according to national guidelines. AEs were graded using the AIDS Clinical Trial Group scale. We present subhazard ratios from competing risk analysis for time to severe AE, accounting for mortality and loss from treatment.

resultsAcross the two sites, 578 eligible patient files were reviewed. 36.7 % were categorized as low weight (≤50 kg) at DR-TB initiation. 76.0 % had no history of TB treatment prior to the current episode of RR TB. 26.8 % were diagnosed with RR TB while hospitalized, indicating poor clinical condition. 82.5 % of patients were also HIV positive, of whom 43.8 % were on ART prior to RR TB treatment and 32.1 % initiated ART with or after RR TB treatment. Median CD4 count was 114.5 (IQR: 45-246.5). Overall, 578 reports of AEs were captured for 204 patients (35.3 %) and 110 patients (19.0 %) had at least one severe AE reported. Patients with at least one AE experienced a median of 3 (IQR: 2-4) AEs per patient. HIV-positive patients with CD4 counts ≤100 cells/mm

conclusionSevere AE are common during the first 6 months of RR TB treatment and HIV-positive patients newly initiating ART have the highest subdistribution hazard ratio for severe AE, accounting for the competing risks of death and loss from treatment.

Indexed as

HIV InfectionsAdolescentAdultAnti-HIV AgentsAntitubercular AgentsCD4 Lymphocyte CountChildCohort StudiesCoinfectionFemaleHumansMaleMiddle AgedRetrospective StudiesRifampinSouth AfricaAnti-HIV AgentsAntitubercular AgentsRifampinAdverse drug reactionsAntiretroviral therapyHIVMulti-drug resistant TBTuberculosis

Identifiers

PMID27769174
PMCPMC5073931

What OpenQuestion holds

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LicenceCC BY
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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.