The challenge of paediatric efavirenz dosing: implications and way forward for the sub-Saharan Africa

The recent U.S.A. Food and Drug Administration (FDA) expansion on indications of efavirenz (EFV) in under 3s [1] may result into many children being treated with EFV-based antiretroviral therapy (ART). The initial thought of EFV as teratogenic in children led to restriction of its use and related research including pharmacokinetic studies in infants and younger children. Anxieties over foetal toxic effects of EFV, an otherwise generally preferred antiretroviral drug, have however been allayed through recent studies [2]. As a result, to date, both FDA and WHO recommend use of EFV fixed-dose combinations as first-line ART for pregnant and breastfeeding mothers. Even though, citing limited pharmacokinetic data, WHO continues to limit its use in under 3s, in May 2013, FDA recommended EFV for children aged at least 3 months. The FDA recommendation points to possible increasing trends in paediatric EFV prescribing.