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

作者：Karen Scott, John O’Rourke, Charlotte Jackson, Luminita Ene, Luisa Galli, Tessa Goetghebuer, Cassidy Henegar, Christoph Königs, Magdalena Marczyńska, Lars Navér, Antoni Noguera‐Julián, P Paioni, José Tomás Ramos, Birgitte Smith, Wipaporn Natalie Songtaweesin, Vana Spoulou, Nattakarn Tantawarak, Anna Turkova, Vani Vannappagari, Алла Волоха, Alasdair Bamford, Hannah Castro, Elizabeth Chappell, G Valle, Caroline Foster, Sara Guillén Martín, Luis Manuel Prieto Tato, Thanyawee Puthanakit, Halyna Sherstiuk, Irina Shkurka, Sandra Soeria‐Atmadja, Ali Judd, Siobhan Crichton, Intira Jeannie Collins, E W Chappell, Siobhan Crichton, Intira Jeannie Collins, G Valle, Charlotte Duff, Kate Edgar, Carlo Giaquinto, Charlotte Jackson, Ali Judd, Laura Mangiarini, John O’Rourke, Karen Scott, Claire Thorne, St Pierre Cohort, Tessa Goetghebuer, Marc Hainaut, Wivine Tremerie, Marc Delforge, Thomas Hoffmann, Sannie Brit Nordly, Birgitte Smith, Christoph Königs, Vana Spoulou, Luisa Galli, Elena Chiappini, Catiuscia Lisi, Montagnani Ca, Elisabetta Venturini, Magdalena Marczyńska, Jolanta Popielska, Maria Pokorska‐Śpiewak, Agnieszka Ołdakowska, Konrad Zawadka, M Pluta, Małgorzata Doroba, Luminita Ene, María José Mellado, Luis Escosa, García Hortelano, T Sainz, Carlos Grasa, Paula Rodríguez, José Tomás Ramos, Pablo Rojo, Luis Manuel Prieto Tato, Cristina Epalza, Alfredo Tagarro, Sara Dominguez, Álvaro Ballesteros, Marta Illán, Arantxa Berzosa, Sara Guillén, B. Soto, María Luisa Navarro, Jesús Saavedra, Mar Santos, Elena Rincón, David Aguilera, Begoña Santiago, Beatriz Lázaro Martín, Andrea López Suárez, Amanda Bermejo, M Penin, Jorge Martínez, Katie Badillo, Ana Belén Jiménez, Adriana Navas, Eider Oñate, Itziar Pocheville, Elisa Garrote, E Colino, Olga Afonso, Jorge Gómez Sirvent, Mónica Garzón, Vicente Román, Raquel Angulo, Hülya Özşahin, Lola Falcón, Pedro Terol, Juan Luis Santos, Álvaro Vázquez, Begoña Carazo, Antonio Medina, Francisco Lendínez, Mercedes Ibáñez, Estrella Peromingo, María Isabel Sánchez, Beatriz Ruiz, Ana Grande, Francisco José Romero, Carlos Pérez, Alejandra Méndez, Laura Calle, Marta Pareja, Begoña Losada, Mercedes Herranz, Bustillo Mc, Pilar Collado, José Antonio Couceiro, Leticia Vila, Consuelo Calviño, Ana Isabel Piqueras, Manuel Oltra, César Gavilán, Elena Montesinos, Marta Dapena, Beatriz Jiménez, Ana Gloria Andrés, Víctor Marugán, Carlos Ochoa, Ana Isabel Menasalvas, Eloísa Cervantes, Ignacio Bernardino, María Luisa Montes, Eulalia Valencia, Ana Delgado, Rafael Rubio, Federico Pulido, Otilia Bisbal, Alfonso Monereo Alonso, Juan Berenguer, Durán Díez C, Teresa Aldamiz, Francisco Tejerina, Juan Carlos Bernaldo de Quirós, Belén Padilla, Raquel Carrillo, Pedro Montilla, Elena Bermúdez, Maricela Valerio, Jose Sanz, Alejandra Gimeno, Miguel Cervero, Rafael Torres, Santiago Moreno, María Jesús Pérez, Santos del Campo, Pablo Ryan, J Vilches Troya, Jesús Sanz, Juan Losa, Rafael Gomez, Miguel Górgolas, Alberto Díaz, Sara de la Fuente, Jose Antonio Iribarren, María José Aramburu, Lourdes Martínez, Ane Josune Goikoetxea, Sofía Ibarra, Mireia de la Peña, Víctor Asensi, Michele Hernández, María Remedios Alemán, Ricardo Pelazas, María del Mar Alonso, Ana M. López, Dácil García, Jehovana Rodríguez, Miguel Ángel Cárdenes, Manuel A Castaño, Francisco Orihuela, Inés Pérez, Mª Isabel Mayorga, López-Cortés Lf, Cristina Roca, Silvia Llaves, María Rios, Jesus Rodriguez, Virginia Palomo, Juan Pasquau, Coral Garcia, Jose Hernandez, Clara Martinez, Antonio Rivero, Ángela Camacho, Dolores Merino, Miguel Raffo, Laura Corpa, Elisa Martínez, Fernando Mateos, José Javier Blanch, M A Torralba, Piedad Arazo, Gloria Samperiz, C D Miralles, Antonio Ocampo, Guille Pousada, Álvaro Mena, Marta Montero, Miguel Salavert, Maria Jose Galindo, Natalia Pretel, J. Portilla, Irene Portilla, Félix Gutiérrez, Mar Masiá, Cati Robledano, Araceli Adsuar, Carmen Hinojosa, Begoña Monteagudo, P Bachiller, Jésica Abadía, Carlos Galera, Helena Albendín, Marian Fernández, Blanco, Pere Soler-Palacín, Beatriz Álvarezand Santiago Pérez-Hoyos, Núria López, María Méndez, Clara Carreras, Borja Guarch, Teresa Vallmanya, Laura Minguell-Domingo, Olga Calavia, Lourdes García, Maite Coll, Berta Pujol, Valentí Pineda, Neus Rius, Núria Rovira, Joaquín Dueñas, C Fortuny, Anna Gamell, Antoni Noguera-Julian, Lars Navér, Sandra Soeria-Atmadja, Vendela Hagås, Johanna Rubin, Nora Einarsson, I A Abela, K Aebi-Popp, A Anagnostopoulos, M Battegay, M Baumann, E Bernasconi, D L Braun, H C Bucher, A Calmy, M Cavassini, A Ciuffi, P A Crisinel, K E A Darling, G Dollenmaier, A Duppenthaler, M Egger, L Elzi, J S Fehr, J Fellay, K Francini, H Furrer, C A Fux, H F Günthard, A Hachfeld, D H U Haerry, B Hasse, H H Hirsch, M Hoffmann, I Hösli, M Huber, D Jackson-Perry, C R Kahlert, O Keiser, T Klimkait, M Kohns, L Kottanattu, R D Kouyos, H Kovari, K Kusejko, N D Labhardt, Karoline Leuzinger, B Martinez de Tejada, C Marzolini, K J Metzner, N Müller, J Nemeth, D Nicca, J Notter, P Paioni, G Pantaleo, M Perreau, Ch Polli, E Ranieri, A Rauch, L P Salazar-Vizcaya, P Schmid, O Segeral, R F Speck, M Stöckle, P E Tarr, M Thanh Lecompte, A Trkola, N Wagner, G Wandeler, M Weisser, S Yerly, Rachaneekorn Nadsasarn, Chutima Saisaengjan, Patama Deeklum, Phattharapa Khamkhen, Lucksanapon Pitikawinwong, Nattakarn Tantawarak, Pope Kosalaraksa, Chanasda Kakkaew, Piangjit Tharnprisan, Hermione Lyall, Alasdair Bamford, Karina Butler, Katja Doerholt, Conor Doherty, Caroline Foster, Ian Harrison, Julia Kenny, Nigel Klein, Gillian Letting, Paddy McMaster, Fungai Murau, Edith Nsangi, Katia Prime, Andrew Riordan, Fiona Shackley, Delane Shingadia, Sharon Storey, G Tudor-Williams, Anna Turkova, Intira Jeannie Collins, Claire Cook, Siobhan Crichton, Donna Dobson, Keith Fairbrother, M Diana Gibb, Ali Judd, Marthe Le Prevost, Nadine Van Looy, Helen Peters, Kate Francis, Claire Thorne, L Thrasyvoulou, S Welch, K Fidler, J Bernatoniene, F Manyika, G Sharpe, B Subramaniam, R Hague, V Price, J Flynn, N Klein, A Bamford, D Shingadia, K Grant, S Yeadon, S Segal, S Hawkins, M Dowie, S Bandi, E Percival, M Eisenhut, L Anguvaa, L Wren, T Flood, A Pickering, P McMaster, C Murphy, J Daniels, Y Lees, F Thompson, A Williams, B Williams, S Pope, S Libeschutz, L Cliffe, S Southall, A Freeman, H Freeman, S Christie, A Gordon, D Rosie Hague, L Clarke, L Jones, L Brown, M Greenberg, C Benson, A Riordan, L Ibberson, F Shackley, S Patel, J Hancock, K Doerholt, K Prime, M Sharland, S Storey, E G H Lyall, C Foster, P Seery, G Tudor-Williams, N Kirkhope, S Raghunanan, Julia Kenny, A Callaghan, A Bridgwood, P McMaster, J Evans, E Blake, A Yannoulias, T Kaleeva, Y Baryshnikova, S Soloha, N Bashkatova, I Raus, O Glutshenko, Z Ruban, N Prymak, G Kiseleva, Alla Volokha, Ruslan Malyuta, H Bailey · 发表于：Clinical Infectious Diseases · 年份：2025 · DOI：10.1093/cid/ciaf191 · 被引用次数：6 · 研究领域：HIV/AIDS drug development and treatment、HIV/AIDS Research and Interventions、HIV-related health complications and treatments

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 wa...