Viral Suppression, Viral Failure, and Safety Outcomes in Children and Adolescents With HIV on Dolutegravir in Europe and Thailand.
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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, European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) study group
Аннотация
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.