SEARCHCOHORTpediatrics, infectious disease

cohort·pediatrics, infectious disease, epidemiology, public health, observational study·PMC10259212

Realizing the Promise of Dolutegravir in Effectively Treating Children and Adolescents Living With HIV in Real-world Settings in 6 Countries in Eastern and Southern Africa

The Pediatric Infectious Disease Journal · 13 authors, 11 centres

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FIDELITY 100%

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AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

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TL;DR

VLS was maintained in the ART-experienced, and 79.8% of previously unsuppressed individuals achieved VLS.

Full summary

699 CHARS

VLS was maintained in the ART-experienced, and 79.8% of previously unsuppressed individuals achieved VLS. DTG was also effective as a single-drug substitution, maintaining VLS in 95.0% of cases. Safety was high; only 5 patients (0.057 per 100 patient-years) experienced a Grade 3 or 4 adverse event leading to DTG discontinuation. Predictors of achieving VLS included prior use of a protease inhibitor-based regimen and being aged 15-19. Limitations include missing viral load data for some participants and potential selection bias, as DTG was initially prioritized for those already suppressed. The findings support the confident use of DTG for eligible CALHIV in low- and middle-income countries.

STUDY TYPE

cohort

SPECIALTY

pediatrics

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10259212

Realizing the Promise of Dolutegravir in Effectively Treating Children and Adolescents Living With HIV in Real-world Settings in 6 Countries in Eastern and Southern Africa

The Pediatric Infectious Disease Journal

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ABSTRACT

Background: Despite encouraging results from clinical trials and in high-income countries, large-scale data on the effectiveness and safety of dolutegravir (DTG) in children and adolescents living with HIV (CALHIV) are lacking in low- and middle-income countries (LMICs). Methods: Retrospective analysis was performed among CALHIV 0–19 years old and weighing greater than or equal to 20 kg who received DTG from 2017 to 2020 at sites in Botswana, Eswatini, Lesotho, Malawi, Tanzania and Uganda to determine effectiveness, safety and predictors of viral load suppression (VLS) among CALHIV using DTG, including through single drug substitutions (SDS). Results: Among 9419 CALHIV using DTG, 7898 had a documented post-DTG VL, and VLS post-DTG was 93.4% (7378/7898). VLS for antiretroviral therapy (ART) initiations was 92.4% (246/263), and VLS was maintained for the ART-experienced [92.9% (7026/7560) pre- vs. 93.5% (7071/7560) post-DTG; P = 0.14). Among previously unsuppressed, 79.8% (426/534) achieved VLS with DTG. Only 5 patients reported a Grade 3 or 4 adverse event (0.057 per 100 patient-years) requiring DTG discontinuation. History of protease inhibitor-based ART [odds ratio (OR) = 1.53; 95% confidence interval (CI): 1.16–2.03], care in Tanzania (OR = 5.45; 95% CI: 3.41–8.70), and being 15–19 years old (OR = 1.31; 95% CI: 1.03–1.65) were associated with gain of VLS post-DTG. Predictors of VLS on DTG included VLS before DTG (OR = 3.87; 95% CI: 3.03–4.95) and using the once-daily, single tab tenofovir-lamivudine-DTG regimen (OR = 1.78; 95% CI: 1.43–2.22). SDS maintained VLS [95.9% (2032/2120) pre- vs. 95.0% (2014/2120) post-SDS with DTG; P = 0.19], and 83.0% (73/88) of unsuppressed gained VLS using SDS with DTG. Conclusions: We found DTG to be highly effective and safe within our cohort of CALHIV in LMICs. These findings can empower clinicians to prescribe DTG confidently to eligible CALHIV. Keywords: HIV/AIDS, children, adolescents, dolutegravir, LMIC

CITATION EXPORT

Jason Michael Bacha, Sandile Dlamini, Florence Anabwani et al.. Realizing the Promise of Dolutegravir in Effectively Treating Children and Adolescents Living With HIV in Real-world Settings in 6 Countries in Eastern and Southern Africa. The Pediatric Infectious Disease Journal. (2023). https://doi.org/10.1097/INF.0000000000003878

AUTHORS

13 · 11 CENTRES

Jason Michael Bacha, Sandile Dlamini, Florence Anabwani, Judith Gwimile, Jacqueline Balungi Kanywa, John Farirai, Menard Bvumbwe, Mabene Tsotako, Teresa Steffy, Diane Nguyen, Jose Euberto Mendez-Reyes, Peter Elyanu, Heather Haq

From the *Department of Pediatrics, Baylor College of Medicine, Houston, Texas
†Baylor College of Medicine International Pediatric AIDS Initiative (BIPAI) at Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas
‡Baylor College of Medicine Children’s Foundation - Tanzania, Mbeya, Tanzania
§Baylor College of Medicine Children’s Foundation - Eswatini, Mbabane, Eswatini
¶Baylor College of Medicine Children’s Foundation - Tanzania, Mwanza, Tanzania
‖Baylor College of Medicine Children’s Foundation - Uganda, Kampala, Uganda
**Botswana-Baylor Children’s Clinical Centre of Excellence Trust, Gaborone, Botswana
††Baylor College of Medicine Children’s Foundation - Malawi, Lilongwe, Malawi
‡‡Baylor College of Medicine Children’s Foundation – Lesotho, Maseru, Lesotho
§§Department of Education, Innovation, and Technology, Baylor College of Medicine, Houston, Texas
¶¶Texas Children’s Hospital, Houston, Texas.