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

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Scott K.
  • O'Rourke J.
  • Jackson C.
  • Ene L.
  • Galli L.
  • Goetghebuer T.
  • Henegar C.
  • Königs C.
  • Marczynska M.
  • Naver L.
  • Noguera-Julian A.
  • Smith B.
  • Songtaweesin W.N.
  • Spoulou V.
  • Tantawarak N.
  • Turkova A.
  • Vannappagari V.
  • Volokha A.
  • Castro H.
  • Chappell E.
  • Valle G.D.
  • Martín S.G.
  • Tato L.M.P.
  • Puthanakit T.
  • Sherstiuk H.
  • Shkurka I.
  • Soeria-Atmadja S.
  • Judd A.
  • Crichton S.
  • Collins I.J.
  • Duff C.
  • Edgar K.
  • Giaquinto C.
  • Mangiarini L.
  • Hainaut M.
  • Tremerie W.
  • Delforge M.
  • Hoffmann T.U.
  • Nordly S.B.
  • Chiappini E.
  • Lisi C.
  • Montagnani C.
  • Venturini E.
  • Popielska J.
  • Pokorska-Spiewak M.
  • Oldakowska A.
  • Zawadka K.
  • Pluta M.
  • Doroba M.
  • Mellado M.J.
  • Escosa L.
  • Hortelano M.G.
  • Sainz T.
  • Grasa C.
  • Rodriguez P.
  • Ramos J.T.
  • Rojo P.
  • Epalza C.
  • Tagarro A.
  • Dominguez S.
  • Ballesteros A.
  • Illan M.
  • Berzosa A.
  • Guillen S.
  • Sot B.
  • Navarro M.L.
  • Saavedra J.
  • Santos M.
  • Rincon E.
  • Aguilera D.
  • Santiago B.
  • Martin B.L.
  • Lopez Suare A.
  • Bermej A.
  • Pení M.
  • Martíne J.
  • Badill K.
  • Jiméne A.B.
  • Nava A.
  • Oñat E.
  • Pochevill I.
  • Garrot E.
  • Colino E.
  • Afons O.
  • Sirven J.G.
  • Garzón M.
  • Romá V.
  • Angul R.
  • Neth O.
  • Falcó L.
  • Tero P.
  • Santos J.L.
  • Vázque A.
  • Carazo B.
  • Medin A.
  • Lendínez F.
  • Ibáñe M.
  • Peromingo E.
  • Sánche M.I.
  • Rui B.
  • Grand A.
  • Romer F.J.
  • Pérez C.
  • Ménde A.
  • Call L.
  • Parej M.
  • Losad B.
  • Herran M.
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  • Couceir J.A.
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  • Calviñ C.
  • Gavilá C.
  • Montesino E.
  • Dapen M.
  • Jiméne B.
  • André A.G.
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  • Ocho C.
  • Menasalvas A.I.
  • Cervante E.
  • Díez C.
  • Bernardino I.
  • Montes M.L.
  • Valencia E.
  • Delgad A.
  • Rubio R.
  • Pulido F.
  • Bisba O.
  • Alons A.M.
  • Berenguer J.
  • Aldamiz T.
  • Tejerina F.
  • de Quirós J.C.B.
  • Padilla B.
  • Carrillo R.
  • Montilla P.
  • Bermúdez E.
  • Valeri M.
  • Gimen A.
  • Cervero M.
  • Torre R.
  • Moreno S.
  • Perez M.J.
  • del Camp S.
  • Ryan P.
  • Troy J.
  • San J.
  • Losa J.
  • Gome R.
  • Górgola M.
  • Díaz A.
  • de la Fuent S.
  • Iribarren J.A.
  • Aramburu M.J.
  • Martine L.
  • Goikoetxe A.J.
  • Ibarra S.
  • de la Peñ M.
  • Asens V.
  • Hernande M.
  • Alemán M.R.
  • Pelazas R.
  • del Mar Alonso M.
  • López A.M.
  • García D.
  • Rodrigue J.
  • Cardene M.A.
  • Castaño M.A.
  • Orihuela F.
  • Pérez I.
  • Mayorg M.I.
  • Lopez-Cortes L.F.
  • Roca C.
  • Llave S.
  • Rios M.J.
  • Rodriguez J.
  • Palom V.
  • Pasquau J.
  • Garci C.
  • Hernandez J.
  • Martine C.
  • Rivero A.
  • Camach A.
  • Merino D.
  • Raffo M.
  • Corp L.
  • Martinez E.
  • Mateos F.
  • Blanc J.J.
  • Torralb M.
  • Arazo P.
  • Samperi G.
  • Miralles C.
  • Ocampo A.
  • Pousad G.
  • Men A.
  • Galindo M.J.
  • Prete N.
  • Portilla J.
  • Portill I.
  • Gutierrez F.
  • Masia M.
  • Robledano C.
  • Adsua A.
  • Hinojosa C.
  • Monteagud B.
  • Bachille P.
  • Abadí J.
  • Galera C.
  • Albendin H.
  • Fernande M.
  • Blanc J.R.
  • Soler-Palacín P.
  • Pérez-Hoyos B.A.S.
  • López N.
  • Méndez M.
  • Carreras C.
  • Guarch B.
  • Vallmanya T.
  • Minguell-Domingo L.
  • Calavia O.
  • García L.
  • Coll M.
  • Pujol B.
  • Pineda V.
  • Rius N.
  • Rovira N.
  • Dueñas J.
  • Fortuny C.
  • Gamell A.
  • Navér L.
  • Hagås V.
  • Rubin J.
  • Einarsson N.
  • Abela I.A.
  • Aebi-Popp K.
  • Anagnostopoulos A.
  • Battegay M.
  • Baumann M.
  • Bernasconi E.
  • Braun D.L.
  • Bucher H.C.
  • Calmy A.
  • Cavassini M.
  • Ciuffi A.
  • Crisinel P.A.
  • Darling K.E.A.
  • Dollenmaier G.
  • Duppenthaler A.
  • Egger M.
  • Elzi L.
  • Fehr J.S.
  • Fellay J.
  • Francini K.
  • Furrer H.
  • Fux C.A.
  • Günthard H.F.
  • Hachfeld A.
  • Haerry D.H.U.
  • Hasse B.
  • Hirsch H.H.
  • Hoffmann M.
  • Hösli I.
  • Huber M.
  • Jackson-Perry D.
  • Kahlert C.R.
  • Keiser O.
  • Klimkait T.
  • Kohns M.
  • Kottanattu L.
  • Kouyos R.D.
  • Kovari H.
  • Kusejko K.
  • Labhardt N.D.
  • Leuzinger K.
  • de Tejada B.M.
  • Marzolini C.
  • Metzner K.J.
  • Müller N.
  • Nemeth J.
  • Nicca D.
  • Notter J.
  • Paioni P.
  • Pantaleo G.
  • Perreau M.
  • Polli Ch.
  • Ranieri E.
  • Rauch A.
  • Salazar-Vizcaya L.P.
  • Schmid P.
  • Segeral O.
  • Speck R.F.
  • Stöckle M.
  • Tarr P.E.
  • Thanh Lecompte M.
  • Trkola A.
  • Wagner N.
  • Wandeler G.
  • Weisser M.
  • Yerly S.
  • Nadsasarn R.
  • Saisaengjan C.
  • Deeklum P.
  • Khamkhen P.
  • Pitikawinwong L.
  • Kosalaraksa P.
  • Kakkaew C.
  • Tharnprisan P.
  • Lyall H.
  • Butler K.
  • Doerholt K.
  • Doherty C.
  • Harrison I.
  • Kenny J.
  • Letting G.
  • Murau F.
  • Nsangi E.
  • Shackley F.
  • Cook C.
  • Dobson D.
  • Fairbrother K.
  • Gibb D.M.
  • Le Prevost M.
  • Van Looy N.
  • Peters H.
  • Francis K.
  • Manyika F.
  • Thrasyvoulou L.
  • Welch S.
  • Fidler K.
  • Bernatoniene J.
  • Sharpe G.
  • Subramaniam B.
  • Hague R.
  • Price V.
  • Flynn J.
  • Klein N.
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  • Grant K.
  • Yeadon S.
  • Segal S.
  • Hawkins S.
  • Dowie M.
  • Bandi S.
  • Percival E.
  • Eisenhut M.
  • Duncan K.
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  • Wren L.
  • Flood T.
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  • McMaster P.
  • Murphy C.
  • Daniels J.
  • Lees Y.
  • Thompson F.
  • Williams A.
  • Williams B.
  • Pope S.
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  • Cliffe L.
  • Southall S.
  • Freeman A.
  • Freeman H.
  • Christie S.
  • Gordon A.
  • Rosie Hague D.
  • Clarke L.
  • Jones L.
  • Brown L.
  • Greenberg M.
  • Benson C.
  • Riordan A.
  • Ibberson L.
  • Patel S.
  • Hancock J.
  • Prime K.
  • Sharland M.
  • Storey S.
  • Lyall E.G.H.
  • Foster C.
  • Seery P.
  • Tudor-Williams G.
  • Kirkhope N.
  • Raghunanan S.
  • Callaghan A.
  • Bridgwood A.
  • Evans J.
  • Blake E.
  • Yannoulias A.
  • Kaleeva T.
  • Baryshnikova Y.
  • Soloha S.
  • Bashkatova N.
  • Raus I.
  • Glutshenko O.
  • Ruban Z.
  • Prymak N.
  • Kiseleva G.
  • Malyuta R.
  • Bailey H.
  • Thorne C.

Grupos

Abstract

Background Dolutegravir (DTG) is a preferred anchor antiretroviral therapy (ART) for children and adolescents with HIV (CAWH). Methods We 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. Results Of 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%). Conclusions DTG 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. © 2025 The Author(s).

Datos de la publicación

ISSN/ISSNe:
1058-4838, 1537-6591

CLINICAL INFECTIOUS DISEASES  OXFORD UNIV PRESS INC

Tipo:
Article
Páginas:
115-127
PubMed:
40215206
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
4,394 SCImago ℠
Cuartil:
Q1 SCImago ℠

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Keywords

  • Adolescent; Anti-HIV Agents; Child; Child, Preschool; Europe; Female; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV Integrase Inhibitors; Humans; Infant; Infant, Newborn; Male; Oxazines; Piperazines; Pyridones; Thailand; Treatment Failure; Treatment Outcome; Viral Load; abacavir; dolutegravir; lamivudine; proteinase inhibitor; RNA directed DNA polymerase inhibitor; tenofovir alafenamide; tenofovir disoproxil; anti human immunodeficiency virus agent; dolutegravir; fused heterocyclic rings; integrase inhibitor; oxazine derivative; piperazine derivative; pyridone derivative; adolescent; adult; age; antiretroviral therapy; Article; child; clinical outcome; clinical study; cohort analysis; cumulative incidence; disease severity; drug efficacy; drug safety; Europe; female; follow up; human; Human immunodeficiency virus infection; human tissue; infant; major clinical study; male; sex; Thailand; treatment failure; viremia; virus load; drug effect; drug therapy; epidemiology; Human immuno

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