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

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 (v...

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Autores: Scott, Karen, O’Rourke, John, Jackson, Charlotte, Ene, Luminita, Galli, Luisa, Goetghebuer, Tessa, Henegar, Cassidy, Königs, Christoph, Marczyńska, Magdalena, Naver, Lars, Noguera-Julian, Antoni, Paioni, Paolo, Ramos, Jose T, Smith, Birgitte, Songtaweesin, Wipaporn Natalie, Spoulou, Vana, Tantawarak, Nattakarn, Turkova, Anna, Vannappagari, Vani, Volokha, Alla, Bamford, Alastair, Castro, Hannah, Chappell, Elizabeth, Dalla Valle, Giorgia, Foster, Caroline, Guillén Martín, Sara, Prieto Tato, Luis Manuel, Puthanakit, Thanyawee, Sherstiuk, Halyna, Shkurka, Irina, Soeria-Atmadja, Sandra, Judd, Ali, Crichton, Siobhan, Collins, Intira Jeannie, Duff, Charlotte, Edgar, Kate, Giaquinto, Carlo, Mangiarini, Laura, Thorne, Claire, Cohort, St Pierre, Hainaut, Marc, Tremerie, Wivine, Delforge, Marc, Hoffmann, Thomas Ulrik, Nordly, Sannie Brit, Chiappini, Elena, Lisi, Catiuscia, Montagnani, Carlotta, Venturini, Elisabetta, Popielska, Jolanta, Pokorska-Śpiewak, Maria, Ołdakowska, Agnieszka, Zawadka, Konrad, Pluta, Magdalena, Doroba, Małgorzata, Mellado, María José, Escosa, Luis, Hortelano, Milagros García, Sainz, Talía, Grasa, Carlos, Rodríguez, Paula, Ramos, Jose Tomás, Rojo, Pablo, Tato, Luis Manuel Prieto, Epalza, Cristina, Tagarro, Alfredo, Domínguez, Sara, Ballesteros, Álvaro, Illán, Marta, Berzosa, Arantxa, Guillén, Sara, Soto, Beatriz, Navarro, María Luisa, Saavedra, Jesús, Santos, Mar, Rincón, Elena, Aguilera, David, Santiago, Begoña, Martín, Beatriz Lázaro, Suárez, Andrea López, Bermejo, Amanda, Penín, María, Martínez, Jorge, Badillo, Katie, Jiménez, Ana Belén, Navas, Adriana, Oñate, Eider, Pocheville, Itziar, Garrote, Elisa, Colino, Elena, Afonso, Olga, Sirvent, Jorge Gómez, Garzón, Mónica, Román, Vicente, Angulo, Raquel, Neth, Olaf, Falcón, Lola, Terol, Pedro, Santos, Juan Luis, Vázquez, Álvaro, Carazo, Begoña, Medina, Antonio, Lendínez, Francisco, Ibáñez, Mercedes, Peromingo, Estrella, Sánchez, María Isabel, Ruiz, Beatriz, Grande, Ana, Romero, Francisco José, Pérez, Carlos, Méndez, Alejandra, Calle, Laura, Pareja, Marta, Losada, Begoña, Herranz, Mercedes, Bustillo, Matilde, Collado, Pilar, Couceiro, José Antonio, Vila, Leticia, Calviño, Consuelo, Piqueras, Ana Isabel, Oltra, Manuel, Gavilán, César, Montesinos, Elena, Dapena, Marta, Jiménez, Beatriz, Andrés, Ana Gloria, Marugán, Víctor, Ochoa, Carlos, Menasalvas, Ana Isabel, Cervantes, Eloísa, Bernardino, Ignacio, Montes, María Luisa, Valencia, Eulalia, Delgado, Ana, Rubio, Rafael, Pulido, Federico, Bisbal, Otilia, Alonso, Alfonso Monereo, Berenguer, Juan, Díez, Cristina, Aldamiz, Teresa, Tejerina, Francisco, de Quirós, Juan Carlos Bernaldo, Padilla, Belén, Carrillo, Raquel, Montilla, Pedro, Bermúdez, Elena, Valerio, Maricela, Sanz, Jose, Gimeno, Alejandra, Cervero, Miguel, Torres, Rafael, Moreno, Santiago, Perez, María Jesús, del Campo, Santos, Ryan, Pablo, Troya, Jesus, Sanz, Jesus, Losa, Juan, Gomez, Rafael, Górgolas, Miguel, Díaz, Alberto, de la Fuente, Sara, Iribarren, Jose Antonio, Aramburu, Marıa Jose, Martinez, Lourdes, Goikoetxea, Ane Josune, Ibarra, Sofia, de la Peña, Mireia, Asensi, Víctor, Hernandez, Michele, Alemán, María Remedios, Pelazas, Ricardo, del Mar Alonso, María, López, Ana María, García, Dácil, Rodriguez, Jehovana, Cardenes, Miguel Angel, Castaño, Manuel A, Orihuela, Francisco, Pérez, Inés, Mayorga, Mª Isabel, Lopez-Cortes, Luis Fernando, Roca, Cristina, Llaves, Silvia, Rios, Marıa Jose, Rodriguez, Jesus, Palomo, Virginia, Pasquau, Juan, Garcia, Coral, Hernandez, Jose, Martinez, Clara, Rivero, Antonio, Camacho, Angela, Merino, Dolores, Raffo, Miguel, Corpa, Laura, Martinez, Elisa, Mateos, Fernando, Blanch, Jose Javier, Torralba, Miguel, Arazo, Piedad, Samperiz, Gloria, Miralles, Celia, Ocampo, Antonio, Pousada, Guille, Mena, Alvaro, Montero, Marta, Salavert, Miguel, Galindo, Maria Jose, Pretel, Natalia, Portilla, Joaquín, Portilla, Irene, Gutierrez, Felix, Masia, Mar, Robledano, Cati, Adsuar, Araceli, Hinojosa, Carmen, Monteagudo, Begoña, Bachiller, Pablo, Abadía, Jesica, Galera, Carlos, Albendin, Helena, Fernandez, Marian, Blanco, Jose Ramon, Soler-Palacín, Pere, Pérez-Hoyos, Beatriz Álvarezand Santiago, López, Núria, Méndez, María, Carreras, Clara, Guarch, Borja, Vallmanya, Teresa, Minguell-Domingo, Laura, Calavia, Olga, García, Lourdes, Coll, Maite, Pujol, Berta, Pineda, Valentí, Rius, Neus, Rovira, Núria, Dueñas Morales, Joaquin, Fortuny, Clàudia, Gamell, Anna, Navér, Lars, Hagås, Vendela, Rubin, Johanna, Einarsson, Nora, 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, Karoline, de Tejada, B Martinez, 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, Lecompte, M Thanh, Trkola, A, Wagner, N, Wandeler, G, Weisser, M, Yerly, S, Nadsasarn, Rachaneekorn, Saisaengjan, Chutima, Deeklum, Patama, Khamkhen, Phattharapa, Pitikawinwong, Lucksanapon, Kosalaraksa, Pope, Kakkaew, Chanasda, Tharnprisan, Piangjit, Lyall, Hermione, Bamford, Alasdair, Butler, Karina, Doerholt, Katja, Doherty, Conor, Harrison, Ian, Kenny, Julia, Klein, Nigel, Letting, Gillian, McMaster, Paddy, Murau, Fungai, Nsangi, Edith, Prime, Katia, Riordan, Andrew, Shackley, Fiona, Shingadia, Delane, Storey, Sharon, Tudor-Williams, Gareth, Cook, Claire, Dobson, Donna, Fairbrother, Keith, Diana Gibb, M, Le Prevost, Marthe, Van Looy, Nadine, Peters, Helen, Francis, Kate, Thrasyvoulou, L, Welch, S, Fidler, K, Bernatoniene, J, Manyika, F, Sharpe, G, Subramaniam, B, Hague, R, Price, V, Flynn, J, Klein, N, Bamford, A, Shingadia, D, Grant, K, Yeadon, S, Segal, S, Hawkins, S, Dowie, M, Bandi, S, Percival, E, Eisenhut, M, Anguvaa, L, Wren, L, Flood, T, Pickering, A, McMaster, P, Murphy, C, Daniels, J, Lees, Y, Thompson, F, Williams, A, Williams, B, Pope, S, Libeschutz, S, Cliffe, L, Southall, S, Freeman, A, Freeman, H, Christie, S, Gordon, A, Hague, D Rosie, Clarke, L, Jones, L, Brown, L, Greenberg, M, Benson, C, Riordan, A, Ibberson, L, Shackley, F, Patel, S, Hancock, J, Doerholt, K, 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, Ruslan, Bailey, H
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/26778
Acceso en línea:https://hdl.handle.net/20.500.13003/26778
Access Level:acceso abierto
Palabra clave:Adolescent
Anti-HIV Agents
Child
Child, Preschool
Europe
Female
HIV Infections
HIV Integrase Inhibitors
Heterocyclic Compounds, 3-Ring
Humans
Infant
Infant, Newborn
Male
Oxazines
Piperazines
Pyridones
Thailand
Treatment Failure
Treatment Outcome
Viral Load
Adolescente
Fármacos Anti-VIH
Niño
Preescolar
Europa (Continente)
Femenino
Infecciones por VIH
Inhibidores de Integrasa VIH
Compuestos Heterocíclicos con 3 Anillos
Humanos
Lactante
Recién Nacido
Masculino
Oxazinas
Piperazinas
Piridonas
Tailandia
Insuficiencia del Tratamiento
Resultado del Tratamiento
Carga Viral
ART
HIV
children/adolescents
dolutegravir
effectiveness
Descripción
Sumario: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.