Researchers at the University of Colorado Anschutz Medical Campus have made a significant breakthrough in the treatment of children infected with HIV. The team confirmed the dose, safety, and efficacy of a drug formulation specifically designed for children, providing a major advancement in the fight against this global health crisis.
The groundbreaking study involved combining three drugs – dolutegravir, abacavir, and lamivudine – into a single fixed-dose combination (FDC) formulation. The researchers discovered that this combination was not only safe and well-tolerated but also highly effective in treating HIV in children. The dosing of the medication was also found to be fair based on the concentrations of each drug in the blood.
For children living with HIV, treatment has always been particularly challenging. Multiple tablets and unpleasant-tasting liquids have often been necessary, making it difficult for caregivers to administer the medication. However, this new FDC formulation containing dolutegravir provides a more convenient and child-friendly treatment option. As Kristina Brooks, an assistant professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, explained, This is the first FDC containing dolutegravir that can be used for children from 13 to 88 pounds.
Dolutegravir, abacavir, and lamivudine have already demonstrated their safety and efficacy in treating HIV in adults and adolescents worldwide. For this study, Brooks and her team worked alongside the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network to assess the previously available immediate-release tablet as well as a new formulation of dispersible release tablets containing all three drugs. The positive results witnessed in adults and adolescents were successfully replicated in this study, further validating the use of these medications in children.
The trial involved 57 children across five different weight bands in four countries. Out of these participants, 54 children used the new combination over a 24-week period. Remarkably, 98 percent of those who continued taking the medication had their HIV levels suppressed below 200 copies/mL at week 24. These findings indicate the safety, tolerability, and effectiveness of the new FDC formulation.
The availability of child-friendly FDC formulations for HIV treatment has been limited thus far. However, this newly developed formulation holds great promise in improving treatment outcomes for children with HIV. It can help ensure continuity of treatment and make medication administration easier for caregivers. Furthermore, the study supported recent labeling updates by the U.S. Food and Drug Administration, expanding the age and weight range for which this formulation can be prescribed to children.
Currently, there are two million children living with HIV worldwide, with only 52 percent receiving therapy. Despite representing only four percent of the global HIV population, children account for 15 percent of AIDS-related deaths. Studies like this are crucial in improving these outcomes and making medication more accessible for children across the globe.
Brooks emphasized the need for continued efforts to develop child-friendly treatment options, stating, We must continue to pursue child-friendly treatment options to overcome the current global disparity in treatment outcomes between children and adults.
While the initial trial results are promising, the team is also evaluating the longer-term safety, tolerability, and effectiveness of the new formulation over 12 months of treatment. These findings will be reported separately, providing further insights into the potential of this innovative drug combination.
In conclusion, the University of Colorado study’s findings have significant implications for the treatment of children with HIV. By developing a safe, effective, and child-friendly fixed-dose combination formulation, researchers have made great strides in improving treatment outcomes and enhancing the lives of children living with HIV. This breakthrough offers hope for a better future in the global fight against HIV/AIDS.
