Evidence map›Paper›PMID 28399804›Full record

ArticleBMC infectious diseases2017

HLA-B*57:01 allele prevalence in HIV-infected North American subjects and the impact of allele testing on the incidence of abacavir-associated hypersensitivity reaction in HLA-B*57:01-negative subjects.

Catherine Butkus Small, David A Margolis, Mark S Shaefer, Lisa L Ross

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01102972 (A Prospective, Randomized, Multicenter, Open-Label Study to Compare the Efficacy and Safety of Simplifying From a Regimen of Atazanavir), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
3.8field-weighted citation impact, top 7% 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.

NCT01102972 phase4completednot on this map

A Prospective, Randomized, Multicenter, Open-Label Study to Compare the Efficacy and Safety of Simplifying From a Regimen of Atazanavir (ATV) + Ritonavir (RTV) + Tenofovir/Emtricitabine to ATV + Abacavir/Lamivudine Without RTV in Virologically Suppressed, HIV-1 Infected, HLA-B*5701 Negative Subjects

TypeinterventionalSponsorViiV HealthcareRan2010 to 2012Enrolled297ConditionsInfection, Human Immunodeficiency VirusArmsReyataz + Norvir + Truvada, Reyataz + Epzicom
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
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  10. A Comprehensive Review ofPharmaceuticals (Basel, Switzerland) · 2021
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  15. Genetic Testing in Clinical Settings.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2018
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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

4 authors at 2 institutions in 1 country.

Catherine Butkus SmallWeill Cornell Medical College, New York, NY, USA.
David A MargolisViiV Healthcare, Research Triangle Park, NC, USA.
Mark S ShaeferViiV Healthcare, Research Triangle Park, NC, USA.
Lisa L RossViiV Healthcare, Research Triangle Park, NC, USA. Lisa.l.ross@viivhealthcare.com.
Triangle · USNew York Medical College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe presence of the HLA-B*57:01 allele in HIV-infected subjects is associated with a higher risk of abacavir-associated hypersensitivity reaction (ABC HSR). HLA-B*57:01 allele prevalence varies in different populations, but HLA-B*57:01 testing with immunological confirmation has had a negative predictive value for ABC HSR between 97 and 100%.

methodsIn the ASSURE study (EPZ113734), the HLA-B*57:01 prevalence in virologically suppressed, antiretroviral treatment-experienced, HIV-infected subjects from the United States, including Puerto Rico, was assessed.

resultsThree hundred eighty-five subjects were screened; 13 were HLA-B*57:01 positive and 372 were negative. Only HLA-B*57:01-negative, abacavir-naive subjects were eligible to enroll into the ASSURE trial. Eleven of the 13 subjects who possessed the HLA-B*57:01 allele were white, the other 2 were African-American. There was no geographic clustering of HLA-B*57:01-positive subjects, and the incidence correlated roughly with those states with the greatest numbers of subjects screened. Similarly, there was no statistically significant correlation between subjects who possessed or lacked the allele and age, gender, ethnicity or CD4+ T-cell numbers. The incidence of ABC HSR following abacavir initiation was also evaluated. Only 1 of 199 HLA-B*57:01-negative subjects (an African-American male) randomized to receive abacavir-containing treatment developed symptoms consistent with suspected ABC HSR; ABC HSR was not immunologically confirmed.

conclusionsThese findings confirm the utility of HLA-B*57:01 allele testing to reduce the frequency of ABC HSR. The prevalence of HLA-B*57:01 positivity was higher in white than in African-American subjects. In HLA-B*57:01-negative subjects, suspected ABC HSR is very rare, but should lead to discontinuation of abacavir when ABC HSR cannot be definitively excluded from the differential diagnosis.

trial registrationThe ASSURE (EPZ113734) study was registered on ClinicalTrials.gov registration on April 8th 2010 and the registration number is NCT01102972.

Indexed as

AbacavirAdultAnti-HIV AgentsBlack or African AmericanCD4 Lymphocyte CountDideoxynucleosidesDrug HypersensitivityFemaleGene FrequencyHIV InfectionsHLA-B AntigensHumansMaleMiddle AgedUnited StatesWhite PeopleAbacavirAnti-HIV AgentsDideoxynucleosidesHLA-B57 antigenHLA-B AntigensAbacavirHIV infectionHLA-B*57:01HypersensitivityLamivudine

Identifiers

PMID28399804
PMCPMC5387336
OpenAlexW2607161737

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.