Once-a-Day Dolutegravir-Based Treatment Is Effective at Suppressing HIV in Children

A once-a-day antiretroviral medicine is more effective at suppressing HIV than standard treatments, as well as easier for children to take and at a low cost, according to investigators at the University College London.

The study results, published in The New England Journal of Medicine, show that dolutegravir-based regimens, which are used to treat adults, reduced the chances of treatments not working among individuals aged 3 to 18 years by about 40% compared with standard treatment.

The findings were based on a randomized controlled trial called ODYSSEY, which involved more than 700 individuals from 29 clinical centers in Africa, Asia, and Europe, who were randomly given either dolutegravir or the standard anti-HIV drugs. Individuals were followed up for at least 2 years.

The findings from the trial, which was sponsored by the Penta Foundation and funded by ViiV Healthcare, informed new guidance by the World Health Organization, recommending the use of dolutegravir-based treatment for pediatrics.

“Medical treatments for children often lag woefully behind those of adults because of the separate formulations and studies that are needed. With the evidence from ODYSSEY which used simplified dosing, this treatment gap has been reduced and we hope that countries can quickly scale up children’s access to treatment globally,” Diana Gibb, PhD, professor of epidemiology and pediatrician at the MRC Clinical Trials Unit at UCL, said in a statement.

Investigators found that 14% of pediatric individuals receiving dolutegravir did not have successful treatments over 2 years compared with 22% of those receiving standard treatment.

Lack of success with treatment failure was deemed to occur if the virus became measurable in the blood, if it was not fully suppressed, or if the individual had symptoms of HIV-related ill health.

These failures could be a result of the drug not being taken as well as the drug not working.

“About 1.8 million children live with HIV but they have had limited treatment options, with medicines that taste unpalatable, that need to be taken twice a day or that come in large pills that are difficult to swallow.” Anna Turkova, MD, a part of the MRC Clinical Trials Unit at UCL, said in the statement.

“Dolutegravir is given in small tablets usually once a day, and the baby pills can be dispersed in water, meaning it’s a lot easier for young children to take. This is important in encouraging uptake of the treatment and adherence to it over many years,” Turkova said.

“Sadly, only about half of children living with HIV are currently receiving g treatment, and those who are not treated face high risks of impaired immunity and worsening health,” she said.

The individuals weighed more than 14 kg and most were over aged 6 years.

Evidence has shown that dolutegravir has a high genetic barrier to resistance in adults, which means that the viruses are less likely to become resistant to it over time, which is what investigators tried to replicate in the ODYSSEY trial among pediatrics and adolescents.

Reference

Easy-to-take medicine better at suppressing HIV in children. EurekAlert. News release. December 29, 2021. Accessed January 3, 2021. https://www.eurekalert.org/news-releases/939007