# Antiretroviral medications for pediatric use in the context of the Unified Health System: are there therapeutic gaps in Brazil?

## TL;DR

This paper examines the availability and suitability of antiretroviral medications for children in Brazil's healthcare system, identifying gaps and opportunities for improvement.

## Contribution

The study provides a comparative analysis of Brazil's and WHO's pediatric antiretroviral drug lists, highlighting formulation disparities and regulatory updates.

## Key findings

- Brazil's list includes 16 pediatric-suitable antiretrovirals, more than the WHO's 2023 list.
- Only one new child-friendly antiretroviral (dolutegravir) was recently incorporated into the Unified Health System.
- Implementation of protocols for manipulating solid drug forms is urgently needed to improve treatment adherence.

## Abstract

To evaluate the incorporation and adequacy of antiretrovirals for the treatment of HIV in children within the context of the Unified Health System in Brazil.

Data were collected from the 2022 edition of the Brazilian National List of Essential Medicines and compared with the World Health Organization’s 2023 Essential Medicines List for Children. Furthermore, records from the Brazilian Health Regulatory Agency were reviewed for new medications and pediatric formulations with the potential to fill identified gaps.

Twenty-one antiretrovirals are listed in the latest edition of the National List of Essential Medicines, of which 16 are suitable for pediatric use. These formulations are available predominantly in tablets (44.4%), oral solutions (22.2%), and capsules (14.8%). Compared to the World Health Organization list, the Brazilian list offers more pediatric options, including, for example, efavirenz (removed from the international list) and tipranavir. The only medication included on the international list that is registered in Brazil but not listed on the national list is the 25 mg chewable tablet of raltegravir. Recently, the Brazilian Health Regulatory Agency registered six new antiretroviral medications, with only one being child-friendly (dolutegravir) and it was incorporated into the Unified Health System.

The comparison between the national and international essential medicines lists highlights the greater variety of pediatric antiretrovirals in Brazil but underscores the need for more child-friendly formulations. The implementation of protocols for the manipulation and fractionation of solid pharmaceutical forms is urgent in order to improve treatment adherence and therapeutic efficacy.