(HealthDay News) — Dolutegravir-based antiretroviral therapy (ART) is superior to standard care for first- and second-line treatment of HIV in children and adolescents, according to a study published in the Dec. 30 issue of the New England Journal of Medicine.
Anna Turkova, MD, from University College London, and colleagues conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with non-dolutegravir-based ART (standard care) in children and adolescents starting first- or second-line ART. A total of 707 children weighing at least 14kg were randomly assigned to dolutegravir-based ART or standard care (350 and 357 participants, respectively). By design, 44% and 56% of the participants started first-line ART (92% of standard-care group received efavirenz-based ART) and second-line ART (98% of standard-care group received boosted protease inhibitor-based ART), respectively.
The researchers found that by 96 weeks, 47 and 75 participants in the dolutegravir and standard care groups, respectively, had treatment failure (estimated probability, 0.14 vs 0.22). The treatment effects were comparable for first- and second-line therapies. At least 1 serious adverse event occurred in 35 and 40 participants in the dolutegravir and standard-care groups, respectively; 73 and 86 participants, respectively, had at least 1 adverse event of grade 3 or higher.
“Superior efficacy was evident by 48 weeks, was sustained to 144 weeks, and was consistent across age, weight bands, and nucleoside reverse-transcriptase inhibitor backbone therapies,” the authors write.
The study was funded by ViiV Healthcare, the manufacturer of dolutegravir.