Long-term clinical, immunologic, and virologic outcomes among early-treated children with HIV in Botswana: a nonrandomized controlled clinical trial

Background: Early antiretroviral treatment (ART) improves outcomes in children, but few studies have comprehensively evaluated the impact of ART started from the first week of life.

Methods: Children diagnosed with HIV within 96 hours of life were enrolled into the Early Infant Treatment Study in Botswana and followed on ART for 96 weeks. Nevirapine, zidovudine, and lamivudine were initiated; nevirapine was switched to lopinavir/ritonavir between weeks 2-5 in accordance with gestational age. Clinical and laboratory evaluations occurred at weeks 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96.

Findings: Forty children-initiated ART at a median of 2 (IQR 2, 3) days of life; 38 (95%) completed follow-up through 96 weeks, and 2 (5%) died between 12 and 24 weeks. ART was well tolerated; 9 (24%) children experienced a grade 3 or 4 hematologic event, and 2 (5%) required treatment modification for anemia. The median 96-week CD4 count was 1625 (IQR 1179, 2493) cells/mm3 with only 5/38 (13%) having absolute counts <1000 cells/mm3. Although 23 (61%) had at least one visit with HIV-1 RNA ≥40 copies/mL at or after 24 weeks, 28 (74%) had HIV-1 RNA <40 copies/mL at the 96-week visit. Median cell-associated HIV-1 DNA at 84/96-week PBMCs was 1.9 (IQR 1.0, 2.6) log10 copies/106 cells. Pre-ART reservoir size at birth was predictive of the viral reservoir at 84/96 weeks.

Interpretation: Initiation of ART in the first week of life led to favorable clinical outcomes, preserved CD4 cell counts, and low viral reservoir through 96 weeks of life.

Comments：

The Early Infant Treatment Study in Botswana enrolled newborns diagnosed with HIV within 96 hours of life and followed them on antiretroviral treatment (ART) for 96 weeks. The study found that initiating ART in the first week of life led to favorable clinical outcomes, preserved CD4 cell counts, and low viral reservoir through 96 weeks of life. Most children completed follow-up, and ART was well tolerated. Although some children had detectable HIV-1 RNA at some visits, the majority had undetectable levels by the end of the study. Pre-ART reservoir size at birth was predictive of the viral reservoir at 84/96 weeks.

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S1706	Lamivudine	Lamivudine is a potent nucleoside analog reverse transcriptase inhibitor, used for treatment of chronic HBV and HIV/AIDS. It works by blocking the HIV reverse transcriptase and hepatitis B virus polymerase.

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