Evidence map›Paper›PMID 35288747›Full record

Trial reportThe Journal of antimicrobial chemotherapy2022

Effect of dihydroartemisinin/piperaquine for malaria intermittent preventive treatment on dolutegravir exposure in pregnant women living with HIV.

Clifford G Banda, Dumisile Nkosi, Elizabeth Allen, Lesley Workman, Mwayiwawo Madanitsa, Marumbo Chirwa, Mayamiko Kapulula, Sharon Muyaya, Steven Munharo, Lubbe Wiesner and 5 more

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in The Journal of antimicrobial chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 18% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
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

15 authors at 6 institutions in 3 countries.

Clifford G BandaMalawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.ORCID 0000-0002-0757-5259
Dumisile NkosiMalawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
Elizabeth AllenDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Lesley WorkmanDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Mwayiwawo MadanitsaTraining and Research Unit of Excellence, Blantyre, Malawi.
Marumbo ChirwaMalawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
Mayamiko KapululaTraining and Research Unit of Excellence, Blantyre, Malawi.
Sharon MuyayaTraining and Research Unit of Excellence, Blantyre, Malawi.
Steven MunharoTraining and Research Unit of Excellence, Blantyre, Malawi.
Lubbe WiesnerDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-9070-8699
Kamija S PhiriKamuzu University of Health Sciences, Blantyre, Malawi (formerly College of Medicine and Kamuzu College of Nursing, University of Malawi).
Victor MwapasaKamuzu University of Health Sciences, Blantyre, Malawi (formerly College of Medicine and Kamuzu College of Nursing, University of Malawi).
Feiko O Ter KuileDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.
Gary MaartensDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0003-3080-6606
Karen I BarnesDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-5547-820X
University of Cape Town · ZABlantyre Institute for Community Ophthalmology · MWUniversity of Liverpool · GBUniversity of Malawi · MWLiverpool School of Tropical Medicine · GBMalawi University of Science and Technology · MW

Funding

EDCTP2 TMA2017CDF-1897Medical Research Council MC_PC_MR/P006914/1Thrasher Research Fund 15567
6 · The paper itself

Abstract

backgroundIn sub-Saharan Africa, the burdens of malaria and HIV infections overlap. In settings with moderate-to-high malaria transmission intensity, pregnant women living with HIV (PLWH) require both ART and malaria intermittent preventive treatment (IPTp). Dihydroartemisinin/piperaquine has been identified as a promising alternative to sulfadoxine/pyrimethamine for IPTp. However, another antimalarial drug, artesunate/amodiaquine, similar to dihydroartemisinin/piperaquine, was previously shown to reduce dolutegravir exposure in non-pregnant adults.

objectivesTo investigate the effect of dihydroartemisinin/piperaquine on dolutegravir plasma exposure in pregnant women on dolutegravir-based ART.

methodsWe conducted an open-label, non-randomized, fixed-sequence, pharmacokinetic study in PLWH in Malawi. Dolutegravir concentrations were measured over a 24 h period, before and after the recommended 3 day treatment dose of dihydroartemisinin/piperaquine in 12 pregnant women in their second or third trimester. Non-compartmental analysis was performed, and geometric mean ratios (GMRs) and 90% CIs were generated to compare dolutegravir pharmacokinetic parameters between the two treatment periods.

resultsCo-administration of dihydroartemisinin/piperaquine and dolutegravir increased dolutegravir's overall exposure (AUC0-24) and Cmax by 30% (GMR 1.30; 90% CI 1.11-1.52) and 31% (GMR 1.31; 90% CI 1.13-1.51), respectively. The dolutegravir trough (C24) concentration increased by 42% (GMR 1.42; 90% CI 1.09-1.85). The combined treatments were well tolerated with no serious adverse events observed.

conclusionsDihydroartemisinin/piperaquine may be administered with dolutegravir-based ART in pregnant women as the modest increase in dolutegravir exposure, similar to pharmacokinetic parameter values published previously, ensures its efficacy without any clinically significant adverse events observed in this small study.

Indexed as

AntimalarialsArtemisininsHIV InfectionsMalariaPregnancy Complications, ParasiticQuinolinesAdultDolutegravirDrug CombinationsFemaleHeterocyclic Compounds, 3-RingHumansOxazinesPiperazinesPregnancyPregnant PeopleAntimalarialsArtemisininsartenimolDolutegravirDrug CombinationsHeterocyclic Compounds, 3-RingOxazinespiperaquinePiperazinesPyridonesQuinolines

Identifiers

PMID35288747
PMCPMC9155593
OpenAlexW4221012534

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.