Publication

Title: International epidemiology Databases to Evaluate AIDS (IeDEA) Southern Africa. Abacavir safety and effectiveness in young infants with HIV in South African observational cohorts
Authors: de Waal R, Rabie H, Technau KG, Eley B, Sipambo N, Cotton M, Boulle A, Wood R, Tanser F, Fatti G, Egger M, Davies MA.
Journal: Antivir Ther.,28(2):13596535231168480. doi: 10.1177/13596535231168480: (2023)

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Abstract

Background: WHO guidelines recommend abacavir in first-line antiretroviral treatment for children and neonates. However, there is no approved dose <3 months of age, and data in neonates are limited.

Methods: We included infants who initiated ART aged <3 months, between 2006 and 2019, in nine South African cohorts. In those who received abacavir or zidovudine, we described antiretroviral discontinuation rates; and 6- and 12-month viral suppression (<400 copies/mL). We compared infants aged <28 and ?28 days, those weighing <3 and ?3 kg.

Results: Overall 837/1643 infants (51%) received abacavir and 443 (27%) received zidovudine. Median (interquartile range, IQR) age was 52 days (23-71), CD4 percentage was 27.9 (19.2-38.0), and weight was 4.0 kg (3.0-4.7) at ART initiation. In those with ?1 month's follow-up, 100/718 (14%) infants discontinued abacavir, at a median of 17.5 months (IQR 6.5-39.5). Abacavir discontinuations did not differ by age or weight category (p = 0.4 and 0.2, respectively); and were less frequent than zidovudine discontinuations (adjusted hazard ratio 0.14, 95% confidence interval 0.10-0.20). Viral suppression at 12 months occurred in 43/79 (54%) and 130/250 (52%) of those who started abacavir aged <28 and ?28 days, respectively (p = 0.8); 11/19 (58%) and 31/60 (52%) in those who weighed <3 and ?3 kg, respectively (p = 0.6); and 174/329 (53%) in those on abacavir versus 77/138 (56%) in those on zidovudine (adjusted odds ratio 1.8, 95% confidence interval 1.0-3.2).

Conclusion: Our data suggest that abacavir may be used safely in infants <28 days old or who weigh <3 kg.

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Citation: de Waal R, Rabie H, Technau KG, Eley B, Sipambo N, Cotton M, Boulle A, Wood R, Tanser F, Fatti G, Egger M, Davies MA. International epidemiology Databases to Evaluate AIDS (IeDEA) Southern Africa. Abacavir safety and effectiveness in young infants with HIV in South African observational cohorts Antivir Ther.,28(2):13596535231168480. doi: 10.1177/13596535231168480: (2023).