Evidence map›Paper›PMID 30043384›Full record

ArticleDrug safety2018

Adverse Drug Reactions Among Patients Initiating Second-Line Antiretroviral Therapy in South Africa.

Dorina Onoya, Kamban Hirasen, Liudmyla van den Berg, Jacqui Miot, Lawrence C Long, Matthew P Fox

Open access · hybridAbstract read
In one paragraph

Article in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 13% 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

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.

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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

6 authors at 3 institutions in 2 countries.

Dorina OnoyaHealth Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, 39 Empire Road, Empire Park, Parktown, Johannesburg, 2193, South Africa. donoya@heroza.org.ORCID http://orcid.org/0000-0002-2664-7342
Kamban HirasenHealth Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, 39 Empire Road, Empire Park, Parktown, Johannesburg, 2193, South Africa.
Liudmyla van den BergRight to Care, Johannesburg, South Africa.
Jacqui MiotHealth Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, 39 Empire Road, Empire Park, Parktown, Johannesburg, 2193, South Africa.
Lawrence C LongHealth Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, 39 Empire Road, Empire Park, Parktown, Johannesburg, 2193, South Africa.
Matthew P FoxHealth Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, 39 Empire Road, Empire Park, Parktown, Johannesburg, 2193, South Africa.
University of the Witwatersrand · ZABoston University · USRight to Care · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionUnderstanding the occurrence of antiretroviral (ARV)-related adverse events (AEs) among patients receiving second-line antiretroviral therapy (ART) is important in preventing switches to more limited and expensive third-line regimens.

objectiveThis study aimed to estimate the rates and examine predictors of AEs among adult HIV-1-infected patients receiving second-line ART in the Right to Care (RTC) clinical cohort in South Africa.

methodsThis was a cohort study of HIV-1-infected adult patients (≥ 18 years of age) initiating standard second-line ART in South Africa from 1 April 2004 to 10 January 2016. Our primary outcome was the development of an AE within 24 months of initiating second-line therapy. We used Kaplan-Meier survival analysis to determine AE incidence in the first 24 months of second-line ART. Predictors of AEs were modelled using a Cox proportional hazards model.

resultsA total of 7708 patients initiated second-line ART, with 44.5% developing at least one AE over the first 24 months of second-line treatment. The highest AE incidence was observed among patients receiving abacavir (ABC) + lamivudine (3TC) + ritonavir-boosted lopinavir/atazanavir (LPVr/ATVr) (52.7/100 person-years (PYs), 95% confidence interval (CI): 42.9-64.8), while patients initiated on a tenofovir (TDF) + emtricitabine (FTC)/3TC + LPVr regimen had the lowest rate of AEs (26.4/100 PYs, 95% CI: 24.9-28.3). Clinical predictors of AEs included experiencing AEs when receiving first-line ART (adjusted hazard ratio (aHR) 2.3, 95% CI: 1.9-2.8), lower CD4 cell count (0-199 vs. ≥ 350 cells/mm

conclusionsThe rates of AEs were lowest among patients receiving a TDF-based second-line regimen. Patients with poorer health at the time of switch were at higher risk of AEs when receiving second-line ART and may require closer monitoring to improve the durability of second-line therapy.

Indexed as

HIV-1AdolescentAdultAnti-HIV AgentsAnti-Retroviral AgentsCohort StudiesDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHIV InfectionsHumansMaleProspective StudiesSouth AfricaYoung AdultAnti-HIV AgentsAnti-Retroviral Agents

Identifiers

PMID30043384
PMCPMC6223700
OpenAlexW2884235251

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.