Evidence map›Paper›PMID 40215206›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025

Viral Suppression, Viral Failure, and Safety Outcomes in Children and Adolescents With HIV on Dolutegravir in Europe and Thailand.

Karen Scott, John O'Rourke, Charlotte Jackson, Luminita Ene, Luisa Galli, Tessa Goetghebuer, Cassidy Henegar, Christoph Königs, Magdalena Marczyńska, Lars Naver and 25 more

Abstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

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

  1. Pooled it
  2. Predictors of Treatment Failure in Children With HIV Starting First-line Antiretroviral Therapy in the ODYSSEY Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Trial
  3. Trial
  4. Article
  5. Article
  6. Article
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

35 authors.

Karen ScottMRC Clinical Trials Unit at University College London, London, United Kingdom.ORCID 0000-0001-6459-8468
John O'RourkeMRC Clinical Trials Unit at University College London, London, United Kingdom.
Charlotte JacksonMRC Clinical Trials Unit at University College London, London, United Kingdom.
Luminita EneHIV Department, "Dr. Victor Babes" Hospital for Infectious and Tropical Diseases, Bucharest, Romania.
Luisa GalliInfectious Disease Unit, Meyer Children's Hospital, IRCCS, Florence, Italy.
Tessa GoetghebuerHospital St Pierre Cohort, Université libre de Bruxelles, Brussels, Belgium.
Cassidy HenegarEpidemiology and Real World Evidence, ViiV Healthcare, Durham, North Carolina, USA.
Christoph KönigsGoethe University, University Hospital Frankfurt, Department of Pediatrics and Adolescent Medicine, Frankfurt, Germany.
Magdalena MarczyńskaDepartment of Children's Infectious Diseases, Medical University of Warsaw, Warsaw, Poland.
Lars NaverDepartment of Pediatrics, Karolinska University Hospital, Stockholm, Sweden.
Antoni Noguera-JulianMalalties Infeccioses i Resposta Inflamatòria Sistèmica en Pediatria, Servei de Malalties Infeccioses i Patologia Importada, Institut de Recerca Pediàtrica Sant Joan de Déu, Barcelona, Spain.
Paolo PaioniDivision of Infectious Diseases and Hospital Epidemiology, University Children's Hospital Zurich, Zurich, Switzerland.ORCID 0000-0002-3904-1606
Jose T RamosHospital 12 de Octubre Instituto de Investigación Sanitaria (i+12), Madrid, Spain.
Birgitte SmithDepartment of Pediatrics, Hvidovre University Hospital, Copenhagen, Denmark.
Wipaporn Natalie SongtaweesinDepartment of Pediatrics, and School of Global Health, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Vana SpoulouFirst Department of Pediatrics, "Agia Sofia" Children's Hospital, Athens, Greece.
Nattakarn TantawarakDepartment of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Anna TurkovaMRC Clinical Trials Unit at University College London, London, United Kingdom.
Vani VannappagariEpidemiology and Real World Evidence, ViiV Healthcare, Durham, North Carolina, USA.
Alla VolokhaShupyk National Healthcare, University of Ukraine, Kyiv, Ukraine.
Alastair BamfordMRC Clinical Trials Unit at University College London, London, United Kingdom.
Hannah CastroMRC Clinical Trials Unit at University College London, London, United Kingdom.ORCID 0000-0001-9086-8687
Elizabeth ChappellMRC Clinical Trials Unit at University College London, London, United Kingdom.
Giorgia Dalla ValleFondazione Penta ETS, Padua, Italy.
Caroline FosterDepartment of Pediatric Infectious Diseases, Imperial College Healthcare NHS Trust, London, United Kingdom.
Sara Guillén MartínHospital Universitario de Getafe, Getafe, Spain.
Luis Manuel Prieto TatoHospital 12 de Octubre Instituto de Investigación Sanitaria (i+12), Madrid, Spain.
Thanyawee PuthanakitDepartment of Pediatrics, and School of Global Health, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Halyna SherstiukDepartment of Infectious Diseases, Dnipropetrovsk Regional Medical Center for Socially Significant Diseases, Dnipro, Ukraine.
Irina ShkurkaCenter for the Prevention of HIV Infection/AIDS and Hepatitis, Chernihiv Regional Hospital, Chernihiv, Ukraine.
Sandra Soeria-AtmadjaDepartment of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.
Ali JuddMRC Clinical Trials Unit at University College London, London, United Kingdom.
Siobhan CrichtonDepartament de Cirurgia i Especialitats Medicoquirúrgiques, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona, Barcelona, Spain.
Intira Jeannie CollinsMRC Clinical Trials Unit at University College London, London, United Kingdom.
European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) study group

Funding

Gilead SciencesMedical Research Council MC_UU_00004/03MRC Clinical Trials UnitUniversity College LondonViiV Healthcare
6 · The paper itself

Abstract

backgroundDolutegravir (DTG) is a preferred anchor antiretroviral therapy (ART) for children and adolescents with HIV (CAWH).

methodsWe assessed the effectiveness and safety of DTG in CAWH aged 0-18 years at DTG start in routine care in Europe and Thailand, evaluating viral suppression (viral load [VL] <50 copies/mL), cumulative incidence and associated factors of viral failure (VF; confirmed VL ≥400 copies/mL) and safety outcomes.

resultsOf 1230 CAWH on DTG, 49% were female. At DTG start, median (IQR) age was 14 (11-16) years, 10% were ART-naive, 49% ART-experienced/suppressed (VL <200 copies/mL), 13% ART-experienced/viremic (VL ≥200 copies/mL), and 28% ART-experienced/unknown VL. Median duration on DTG was 93 (49-163) weeks. Virall suppression was 88%-91% throughout follow-up. Cumulative incidence (95% CI) of VF at weeks 96 and 144 was 4.3% (3.1%-6.1%) and 8.3% (6.2%-11.1%). Increased risk of VF was associated with female sex, ART-experienced/viremic, advanced/severe immunosuppression, previous treatment failure, and region (P < .05, adjusting for age, sex and ART/VL status). The risk of VF was lower on DTG than CAWH on protease-inhibitor-based regimens (P < .001). Among 1146 with clinical data, 26 (2%) experienced 52 DTG-related adverse events, including 5 serious adverse events. Of 849 with laboratory data, 44 (5%) had 54 grade ≥3 events (<1 per 100 person-years). DTG discontinuation by weeks 96 and 144 was 5.0% (3.8%-6.7%) and 9.5% (7.5%-12.0%).

conclusionsDTG was well tolerated, with ∼90% virally suppressed <50 copies/mL. VF was low overall but was significantly higher in children/adolescents ART-experienced and viraemic at DTG start, requiring close monitoring.

Indexed as

Anti-HIV AgentsHeterocyclic Compounds, 3-RingHIV InfectionsHIV Integrase InhibitorsViral LoadAdolescentChildChild, PreschoolDolutegravirEuropeFemaleHumansInfantInfant, NewbornMaleOxazinesAnti-HIV AgentsDolutegravirHeterocyclic Compounds, 3-RingHIV Integrase InhibitorsOxazinesPiperazinesPyridonesARTchildren/adolescentsdolutegravireffectivenessHIV

Identifiers

PMID40215206
PMCPMC12596352

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Registered trials

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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.