Researchers confirm dosing, efficacy of pediatric HIV drug combination
Click Here to Manage Email Alerts
Key takeaways:
- Researchers confirmed the dosing of a formulation including dolutegravir, abacavir and lamivudine in children with HIV.
- The combination was shown to suppress the virus after 24 weeks.
Researchers confirmed the dosing of an ART combination designed to treat children with HIV and found that it was safe, well tolerated and efficacious through 24 weeks, according to results published in The Lancet HIV.
“This is the first fixed-dose combination containing dolutegravir that can be used for children from 13 to 88 pounds,” Kristina Brooks, PharmD, an assistant professor in the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado Anschutz Medical Campus, said in a press release.
“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,” Brooks said.
Brooks and colleagues joined the International Maternal Pediatric Adolescent AIDS Clinical Trials Network to examine both an immediate release pill and a new formulation of dispersible release tablets containing dolutegravir, abacavir and lamivudine — three drugs that have been shown to be safe and effective in HIV treatment.
They enrolled 57 children — 26 female and 31male — from four countries in five weight ranges: 6 kg to less than 10 kg, 10 kg to less than 14 kg, 14 kg to less than 20 kg, 20 kg to less than 25 kg, and 25 kg or more. Each participant was either new to ART or virally suppressed on a stable ART regimen for 6 months or longer.
Children weighing 6 kg to less than 25 kg received 60 mg of abacavir, 5 mg of dolutegravir, and 30 mg of lamivudine in three to six dispersible tablets, depending on their weight — children weighing 6 kg to less than 10 kg received three tablets in 15 mL of water, whereas those weighing 10 kg to less than 14 kg (four tablets), 14 kg to less than 20 kg (five tablets) and 20 kg to less than 25 kg (six tablets) received their medication in 20 mL of water.
Children who weighed 25 kg to 40 kg received 600 mg of abacavir, 50 mg of dolutegravir and 300 mg of lamivudine in an immediate-release tablet.
The authors found that in 98% of the participants who continued the study drug remained virally suppressed below 200 copies/mL at week 24.
“The safety, tolerability, and effectiveness of these formulations look very positive,” Brooks said in the release.
She said the new formulation could help enable continuity of treatment, improve treatment outcomes and “make it easier for caregivers responsible for dispensing the drugs.”
“We must continue to pursue child-friendly treatment options to overcome the current global disparity in treatment outcomes between children and adults,” Brooks
References:
- Ruel TD, et al. Lancet HIV. 2023;doi:10.1016/S2352-3018(22)00044-3.
- New HIV drug formulation could improve treatment outcomes for children worldwide. https://www.eurekalert.org/news-releases/997383. Published Aug. 2, 2023. Accessed Aug. 2, 2023.
Collapse
Read more about
Click Here to Manage Email Alerts