New HIV Drug Formulation Could Improve Child Treatment

Researchers at the University of Colorado Anschutz Medical Campus have contributed to the confirmation of the dose, safety, and efficacy of a medication formulation meant to treat children infected with the human immunodeficiency virus (HIV).

The study, which was published in The Lancet HIV, found that combining 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. Dosing was also reasonable based on the concentrations of each medicine in the blood.

“This is the first FDC containing dolutegravir that can be used for children from 13 to 88 pounds,” said Kristina Brooks, PharmD, an assistant professor in the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences at CU Anschutz. HIV treatment in children has historically been challenging as it requires the use of multiple tablets and liquids that don’t always taste the best, and can be challenging to administer.

Dolutegravir, abacavir, and lamivudine have been demonstrated to be safe and effective in the treatment of HIV over the world. Brooks and Jennifer Kiser, PharmD, Ph.D., collaborated with a team of investigators from the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network to examine an existing immediate release tablet as well as a new formulation of dispersible release tablets containing all three drugs to see if it would produce the same positive results in adults and adolescents.

“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,” Brooks said.

There are few HIV FDC formulations for children. According to Brooks, this new formulation could help with treatment continuity, enhance treatment outcomes, and make it easier for caregivers who are in charge of dispensing the drugs. This study also contributed to the FDA’s recent labeling changes, which expanded the use of this formulation to children aged at least 3 months and weighing at least 13 pounds.

Currently, two million children worldwide are infected with HIV. Only 52% are receiving treatment, and while accounting for only 4% of the global HIV population, children account for 15% of AIDS-related fatalities. Such research is critical for improving these results and making medication more widely available around the world.

“We must continue to pursue child-friendly treatment options to overcome the current global disparity in treatment outcomes between children and adults,” Brooks said.

Some of the youngsters who took part in the initial trial are still taking the new medicine formulation as part of an open access program. Long-term safety, tolerability, and effectiveness after 12 months of treatment are being studied and will be reported separately.

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