Novel HIV drug formulation could improve treatment outcomes for children globally

Researchers at the University of Colorado Anschutz Medical Campus have helped confirm the dosing, safety and effectiveness of a drug formulation designed for treating children with human immunodeficiency virus (HIV).

The study was published in The Lancet HIV and reveals a new dispersible formulation and an immediate-release tablet containing three medications - dolutegravir, abacavir and lamivudine - in a single fixed dose combination (FDC) formulation is safe, well tolerated, and effective for treating children with HIV. The dosing based on the concentrations of each medication in the blood was also appropriate.

“This is the first FDC containing dolutegravir that can be used for children from 13 to 88 pounds,” said Kristina Brooks an assistant professor in the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences at CU Anschutz.

Dolutegravir, abacavir and lamivudine have been shown to be safe and effective worldwide to treat HIV. The researchers along with a team of investigators through the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network looked at both an existing immediate release tablet and a new formulation of dispersible release tablets containing all three drugs to see if it would yield the same positive results they have seen in adults and adolescents.

Brooks said,“57 children were enrolled across five weight bands in four countries, of which 54 children used the new combination over 24 weeks. In 98 percent of the participants who continued the study drug, the amount of HIV in the blood remained suppressed below 200 copies/mL at week 24. The safety, tolerability, and effectiveness of these formulations look very positive,”

Reference: Kristina Brooks et al, The Lancet HIV. doi.org/10.1016/S2352-3018(23)00107-8