Dolutegravir-based antiretroviral therapy proved more effective than standard treatments for HIV-positive children, reducing treatment failure by 40%.
Achieving viral suppression with antiretroviral therapy (ART) is critical for people living with HIV. However, children with HIV-1 infection have limited options for ART.
A recent study, published in The New England Journal of Medicine, examined the efficacy of dolutegravir-based ART as a first- or second-line treatment in children living with HIV.
The open label, randomized, noninferiority clinical trial evaluated the safety and effectiveness compared ART based on the integrase inhibitor dolutegravir with non-dolutegravir-based standard-care ART. Participants included HIV-positive children and adolescents commencing first- or second-line ART.
The trial, ODYSSEY, included 29 clinical centers across Africa, Europe, and Asia. In response to the World Health Organization (WHO) recommending dolutegravir based-treatment in children, the trial was sponsored by the Penta Foundation and funded by ViiV healthcare.
From September 2016-June 2018, the investigators randomly assigned dolutegravir-based ART (n=350) or standard care (n=357) to 707 children and adolescents living with HIV. The median age was 12.2 years, ranging from 2.9-18 years, and participants weighed at least 14 kg. 49% of participants were female.
A total of 311 participants (44%) began first-line ART, with 92% of the standard-care group receiving efavirenz-based ART. Second-line ART was initiated in 396 (56%) of participants; 98% of the standard-care group received booster protease inhibitor-based ART.
The study’s primary end point was the proportion of patients with virologic or clinical treatment failure. By 96 weeks, 47 dolutegravir recipients and 75 standard-care recipients had treatment failure. The median follow-up time was 142 weeks. Effects of treatment were comparable between first- and second-line therapies.
A total of 35 participants in the dolutegravir group and 40 in the standard care group reported 1 or more serious adverse events. 73 dolutegravir recipients and 86 standard-care recipients had at least 1 grade 3 or higher serious adverse effect. 1 or more ART-modifying adverse event were reported in 5 dolutegravir recipients and 17 standard-care recipients.
Overall, the dolutegravir-based ART reduced treatment failure by 40% in HIV-positive children 3-18 years old.
The investigators concluded that dolutegravir-based ART was superior to current standard-care treatment in children and adolescents living with HIV.