There is a need for effective antiretroviral treatments for infants and young children with HIV-1, who often face challenges with adherence and limited treatment options. The WHO has recommended the HIV integrase inhibitor dolutegravir as a first-line treatment for HIV-1 since 2018. Its use has however been limited to adults and older children due to formulation issues.

A dispersible tablet formulation of dolutegravir was developed to address this issue; its effectiveness is the subject of the International Maternal Paediatric Adolescent AIDS Clinical Trial (IMPAACT) P1093, an ongoing multicentre, open-label, non-comparative study.

The outcomes for this study were identified as:

• To determine which dose of dolutegravir achieved C₂₄ and the AUC₂₄ in these children.

• Toxicity was the primary safety outcome identified as either grade 3 or 4 adverse events, termination of treatment due to adverse drug events or death.

• The secondary outcomes measured included pharmacokinetic variables, tolerability, and clinical efficacy.

• Virological success was defined as achieving a plasma HIV-1 RNA of less than 400 copies per mL. Other efficacy outcomes included the proportion achieving HIV-1 RNA of less than 50 copies per mL and the change from baseline in CD4 cell count and percentage.

.
The following was recorded:

• 73 participants (48% female, median age of 1 year & median weight of 8·5 kg) received the final proposed dose of dolutegravir.  The dosage schedule can be found here

• The selected dose within each age cohort (≥ two years to <6 years, ≥6 months to <2 years of age and ≥ four weeks to <6 months) achieved geometric mean trough (ng/mL) of 688, 1179, and 1446, and 24 h area-under-the-curve (h·mg/L) of 53, 74, and 65, respectively.

• No grade 3 or worse adverse events were attributed to dolutegravir.

 
Based on these findings, the researchers conclude that using a single dose of dolutegravir dispersible tablets as first-line or second-line treatment for infants and children under six years living with HIV-1 is safe and effective.