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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| 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 |
| 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. |
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