New HIV Drug Formulation Breakthrough for Paediatric Applications
A study published in The Lancet HIV has demonstrated the safety and efficacy of a novel dispersible tablet formulation for children infected with human immunodeficiency virus (HIV).
Thanks to the development of anti-retroviral therapies (ARTs) HIV has gone from a death sentence to an increasingly treatable condition that rarely develops into AIDS. However, the availability of ART for paediatric HIV treatment is still lacking.
“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,” said Kristina Brooks, an Assistant Professor in the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado Anschutz Medical Campus.
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The study evaluated the pharmacokinetics, safety, and tolerability of a fixed-dose combination (FTC) ART which contains abacavir, dolutegravir, and lamivudine in children with HIV under 12 years old. Those three drugs have been the go-to HIV treatment for adults and adolescents, but until now had not been evaluated in paediatric applications.
Brooks and Jennifer Kiser, both researchers at the University of Colorado, worked with The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network to conduct the study. Enrolling patients across five weight bands, they found that the formulation was safe, well tolerated, and effective at treating children with HIV.
“This is the first FDC containing dolutegravir that can be used for children from 13 to 88 pounds,” explained Brooks.
The study, which had 57 participants, took place across four countries for 24 weeks. At the end of the study, 98% of the patients had a viral load of fewer than 200 copies of HIV per millilitre of blood.
“The safety, tolerability, and effectiveness of these formulations look very positive,” Brooks said.
The upshot of this research is improved treatment options for paediatric HIV patients and better ease of use for caregivers administering the drugs. Furthermore, the study has helped expand the use of ARTs for use in children at 3 months old and 13 pounds by the FDA.
Brooks added: “We must continue to pursue child-friendly treatment options to overcome the current global disparity in treatment outcomes between children and adults.”
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