Evidence map›Paper›PMID 27482411›Full record

ArticleJournal of virus eradication2015

Plasma pharmacokinetics of once-daily abacavir- and lamivudine-containing regimens and week 96 efficacy in HIV-infected Thai children.

Torsak Bunupuradah, Passorn Punyahotra, Tim R Cressey, Amornrat Srimuan, Narukjaporn Thammajaruk, Jiratchaya Sophonphan, Chulalak Sriheara, David M Burger, Thanyawee Puthanakit, Jintanat Ananworanich

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of virus eradication, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01656122 (Pharmacokinetics of Abacavir Once Daily vs. Twice Daily and Lamivudine Once Daily vs. Twice Daily in HIV-infected Thai Children), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 78% 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.

NCT01656122 phase2 / phase3completednot on this map

Pharmacokinetics of Abacavir Once Daily vs. Twice Daily and Lamivudine Once Daily vs. Twice Daily in HIV-infected Thai Children

TypeinterventionalSponsorThe HIV Netherlands Australia Thailand Research CollaborationRan2012 to 2015Enrolled30ConditionsHIVArmsabacavir, 3TC
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 4 citations in OpenAlex.

No citing paper in PubMed yet.

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

10 authors at 3 institutions in 2 countries.

Torsak BunupuradahHIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) , Thai Red Cross AIDS Research Centre , Bangkok , Thailand.
Passorn PunyahotraDepartment of Pediatrics, Faculty of Medicine , Chulalongkorn University , Bangkok , Thailand.
Tim R CresseyProgram for HIV Prevention and Treatment (PHPT/IRD174), Faculty of Associated Medical Sciences, Chiang Mai, Thailand; Harvard School of Public Health, Boston, USA.
Amornrat SrimuanHIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) , Thai Red Cross AIDS Research Centre , Bangkok , Thailand.
Narukjaporn ThammajarukHIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) , Thai Red Cross AIDS Research Centre , Bangkok , Thailand.
Jiratchaya SophonphanHIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) , Thai Red Cross AIDS Research Centre , Bangkok , Thailand.
Chulalak SrihearaHIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) , Thai Red Cross AIDS Research Centre , Bangkok , Thailand.
David M BurgerRadboud Institute for Health Sciences (RIHS) , Nijmegen , the Netherlands.
Thanyawee PuthanakitHIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research Centre, Bangkok, Thailand; Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Jintanat AnanworanichHIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research Centre, Bangkok, Thailand; SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand; US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
HIV Netherlands Australia Thailand Research Collaboration · THChulalongkorn University · THHarvard University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAbacavir and lamivudine are approved for once-daily use in HIV-infected adults. Limited pharmacokinetic (PK) data for abacavir and lamivudine in children are available.

methodsA crossover study to compare PK of once- versus twice-daily abacavir and lamivudine was conducted in virologically suppressed HIV-infected Thai children aged <18years, with bodyweight of at least 14 kg, HIV RNA <50 copies/mL and HLA-B*5701 negative. Abacavir and lamivudine daily doses by bodyweight were 300 and 150 mg for 14-<20 kg, 450 and 300 mg for 20-<25 kg, and 600 and 300 mg for ≥25 kg, respectively. Originator abacavir and lamivudine scored tablets were administered. Intensive PK sampling was performed after 14 days of each dose. PK parameters were determined using non-compartmental analysis.

resultsThirty children (57% male) were enrolled, 10 per weight band. Median (IQR) age was 8.8 (6.6-11.3) years and bodyweight was 21.9 (19.2-30.6) kg. The geometric means (GM) AUC0-24 of once- and twice-daily abacavir were 14.43 and 10.65 mg.h/L, respectively. The geometric mean ratio (GMR) of AUC0-24 for once- versus twice-daily abacavir dosing was 1.36 [90% confidence interval (CI) 1.11-1.66]. The GM AUC0-24 of once- and twice-daily lamivudine were 17.70 and 18.11 mg.h/L, respectively. The GMR of AUC0-24 for once- versus twice-daily lamivudine dosing was 0.98 (90% CI 0.84-1.14). At 96 weeks, 90% had HIV RNA <50 copies/mL and there were no serious adverse events.

conclusionAbacavir exposure was greater with once-daily dosing, while lamivudine once- and twice-daily exposures were bioequivalent. Once-daily abacavir and lamivudine using weight-band dosing is a treatment option for children.

Indexed as

abacavirHIV-infected childrenlamivudineonce-dailypharmacokinetics

Identifiers

PMID27482411
PMCPMC4946738
OpenAlexW2537385805

What OpenQuestion holds

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LicenceCC BY-NC
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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.