Innovation across the spectrum of pediatric HIV care: Clinical impact and cost-effectiveness of long-acting antiretroviral therapy for breastfeeding people with HIV and their infants in Zimbabwe

项目总结

Project Summary Improved HIV testing and treatment in antenatal care have markedly increased viral suppression rates among pregnant and breastfeeding people with HIV (PWH) and reduced infant HIV infections. After delivery, however, PWH face unique barriers to ART adherence and are less likely to maintain viral suppression than non-postpartum adults. Viremia, in turn, increases risk of breastmilk HIV transmission to infants, which now accounts for more than half of the 150,000 annual infant HIV infections. Recent data have demonstrated the effectiveness of long-acting injectable ART (LA-ART) for PWH. This promising new technology may overcome challenges in ART adherence for postpartum PWH who are able to access care; this would prevent many infant infections and reduce morbidity and deaths among mothers and children. The World Health Organization (WHO) Pediatric Antiviral Drug Optimization (PADO) group has placed LA-ART formulations for prevention on their list of priority products for expedited development. Clinical trials of LA-ART in postpartum PWH are currently underway or in development by several NIH-supported trials networks. Since 2014, R01 HD079214 has supported the development of the Cost-effectiveness of Preventing AIDS Complications (CEPAC)-Pediatric microsimulation model of HIV prevention, diagnosis, and treatment in children. In Aim 2a of the current parent award (2019-2024), we are evaluating the clinical and economic impact of emerging antiretroviral drug formulations to improve the health of children affected by HIV. We first evaluated strategies for scaling up dolutegravir-based ART for children with HIV. This productive early work demonstrated that the next key questions in pediatric HIV will be focused on prevention. Together with newly emerging data on LA-ART for postpartum PWH, the current Administrative Supplement would allow us to leverage the work done in Aim 2a to address a new policy question currently being considered by NIH trials networks, WHO, and other guidelines-development agencies. We propose two Supplement Specific Aims: Aim A: To project the clinical outcomes and cost-effectiveness of long-acting injectable ART (LA-ART) offered to breastfeeding people with HIV in Zimbabwe. Aim B: To share findings with policymakers, inform emerging guidelines, and guide future research. This analysis, part of Aim 2a, is eligible for an Administrative Supplement according to NICHD criteria: 1) “to address special, time-critical cases such as countering a major threat to public health or taking advantage of … unanticipated opportunities to increase the value of the project consistent with the originally approved objectives,” and 2) “to prepare and disseminate materials …. ensuring that important findings from the project are made widely available in a timely and effective manner.” Support from this supplement will allow us to address a critical, new, time-sensitive question related to the parent R01 objectives: evaluating the clinical and economic impact of novel antiretroviral formulations for children affected by HIV.