Broadly neutralizing antibodies for treatment of HIV in children in the Global South: rationale and challenges.

Despite the rapid scale-up of early infant diagnosis and antiretroviral therapy, pediatric HIV type 1 (HIV-1) remains a remarkable public health as children account for 15% of all AIDS-related deaths worldwide. Broadly neutralizing antibodies (bNAbs) have emerged as a promising strategy for the prevention, treatment, and potential cure of HIV. In adults, bNAbs have proven to be safe and effective, capable of suppressing plasma viremia and delaying viral rebound during analytical treatment interruptions. bNAbs provide immediate passive immunity and long-acting coverage, which makes them suitable for children where high baseline viral loads drive rapid disease progression and reservoir establishment. Several trials have demonstrated that subcutaneous administration of bNAbs is safe and pharmacokinetically feasible in neonates and have provided a proof-of-concept for bNAb-mediated viral control in children. However, the clinical evaluation of bNAbs has primarily been directed towards adult populations in the Global North, leading to limited pediatric clinical data. This research lag represents a critical ethical inequity that risks denying life-saving therapeutics to the most vulnerable populations. Therefore, equitable access in the Global South requires the elimination of structural barriers that currently delay pediatric access through a strategy of intentional early inclusion, technology transfer, and parallel clinical development. Similarly, a multi-faceted approach involving governments in the Global South, funders, stakeholders, and pharmaceutical developers is essential to address intellectual property sharing, licensing, regulatory harmonization, and local manufacturing. The ongoing development of pediatric trials represents an opportunity to achieve long-term viral remission, providing a definitive pathway to end the pediatric HIV epidemic. Prioritizing these studies is a scientific and moral necessity to ensure that children are finally placed at the center of medical innovations and no longer excluded from therapeutic advancements.