- The Paediatric Antiretroviral Drug Optimization (PADO) group confirmed the essential role of ritonavir-boosted darunavir fixed-dose combination and of formulations containing dolutegravir and tenofovir alafenamide, and focused on the potential of long-acting or extended-release antiretroviral products for children living with HIV.
- To ensure global HIV treatment targets, identification and easy access to optimal formulations for infants, children, adolescents and pregnant and lactating women, is necessary.
During its fourth meeting, the Paediatric Antiretroviral Drug Optimization (PADO) group, convened by World Health Organization in December 2018 (Geneva, Switzerland), reviewed emerging evidence on paediatric antiretrovirals to guide industry and interested stakeholders on the formulations most needed in low-income and middle-income countries. At the same time, specific domains for paediatric therapy (such as pharmacokinetics and safety in newborns, potential drug interactions or pill burden in children) were discussed, as well as for pregnant and lactating women, generally excluded from clinical trials and in an urgent need of new antiretrovirals.
In the updated list of priority antiretroviral formulations, PADO4 confirmed the essential role of ritonavir-boosted darunavir fixed-dose combination and of formulations containing dolutegravir and tenofovir alafenamide. Further, several unmet needs for paediatric formulations for treating HIV-associated infections (i.e. tuberculosis or cryptococcal meningitis) were identified.
Then, the PADO group focused on several promising products and technologies under investigation. Particularly, long-acting or extended-release antiretroviral products (parenteral and oral formulations) could have multiple advantages for neonatal prophylaxis and for adolescent care. The group pays close attention to the management of adolescents with HIV, for which drug harmonisation with children and adults is crucial to ensure successful treatment.
PADO group notes that, despite considerable progress in optimising treatment regimens for adults, more than a third of children living with HIV received suboptimal regimens and formulations in 2018. “Without a continued focus on identifying, prioritising, and ensuring access to optimal formulations suitable for infants, children, and adolescents, global HIV treatment targets will not be met” authors concluded.