OBJECTIVES: High resistance to nevirapine was previously reported in Brazil. Thus, an alternative antiretroviral is needed for high-risk neonates exposed to HIV mother-to-child transmission (HIV MTCT). Raltegravir oral granules formulation 100mg was FDA-approved for this population recently. This study aimed to evaluate the cost-effectiveness of raltegravir oral granules prophylaxis compared to nevirapine to prevent HIV MTCT in Brazil in high-risk neonates with gestational age ≥ 37 weeks.

METHODS: Evidence is scarce mainly due to the challenge of conducting clinical trials for this population. Considering this scenario and the intervention's short duration, it was developed a decision tree model to compare the cost-effectiveness of raltegravir oral granules versus nevirapine in the Brazilian Unified Health System (SUS) perspective. Parameters were purchase costs and resistance to raltegravir and nevirapine obtained from published literature. The probabilities of HIV infection for both antiretrovirals with and without resistance were assumed from expert panel information. Considering that these antiretrovirals are components of combined antiretroviral preventive schemes, there is uncertainty about the impact of resistance to a specific component on the efficacy of the whole scheme. In the deterministic sensitivity analyses, both antiretrovirals' resistances were the most critical parameters. Monte Carlo probabilistic sensitivity analysis with 1000 iterations evaluated the uncertainty in the model.

RESULTS: The incremental cost of raltegravir prophylaxis in international dollars (I$) was 430.28. Considering the parameters used, especially the resistance, raltegravir prophylaxis was more effective than nevirapine, and the incremental cost-effectiveness ratio (ICER) resulted in I$ 2,584.29 per avoided case of HIV infection in neonates in the base case scenario.

CONCLUSIONS: From the SUS perspective, despite limitations due to parameter uncertainties for the specific population and considering the exploratory use of a willingness-to-pay threshold (I$ 15,810.28), it would result in a 91% probability of cost-effectiveness for prophylaxis with raltegravir oral granules.