The first fixed dose combination (FDC) formulation containing dolutegravir that is suitable for certain paediatric HIV patients globally, has been deemed safe and effective by US researchers.
A new study published in The Lancet HIV has demonstrated the safety and efficacy of a new dispersible drug formulation of an immediate-release tablet as a human immunodeficiency virus (HIV) treatment for children. The single fixed dose combination (FDC) contains dolutegravir, abacavir and lamivudine.
“This is the first FDC containing dolutegravir that can be used for children from 13 to 88 pounds,” explained 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.
US researchers worked with the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network to investigate an existing immediate release tablet plus a new formulation of dispersible release tablets containing the three drugs, to see if it would produce the same positive results for HIV seen in adults and adolescents.
Administration of HIV treatment in children has been historically challenging, Assistant Professor Brooks noted.
This new formulation offers a potential solution, she stated. It could enable continuity of treatment, improve treatment outcomes and make it easier for caregivers responsible for dispensing the drugs.
Study results for the new HIV drug formulation
Assistant Professor Brooks added that 57 children were enrolled across five weight bands in four countries. “[There were] 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.”
Some of the patients who participated in the initial trial are currently still taking the new drug formulation through an open access programme. Longer-term safety, tolerability and effectiveness through one year of treatment is currently under analysis; this will be reported separately.
Overall support for the IMPAACT Network was provided by the National Institute of Allergy and Infectious Diseases (NIAID). Co-funding was supplied from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH). Additional funding support and the study product was provided by ViiV Healthcare.
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