Among children and adolescents recently diagnosed with HIV infection, first- or second-line treatment with dolutegravir-based antiretroviral therapy (ART) was found to be superior compared with standard care, according to results of a study published in The New England Journal of Medicine.
In this open-label, randomized, noninferiority trial conducted between September 2016 and June 2018, researchers enrolled children and adolescents with HIV infection who weighed at least 14 kg and were starting first- or second-line ART. Patients were randomly assigned in a 1:1 fashion to receive either dolutegravir-based ART or standard care (nondolutegravir-based ART). The primary endpoint was the proportion of patients with virologic or clinical treatment failure at 96 weeks; the mean follow-up duration was 142 weeks.
Among a total of 707 patients included in the study, 350 received dolutegravir-based ART and 357 received standard care. Of these patients, the median age was 12.2 (range, 2.9-18.0) years, the median weight was 30.7 (range, 14.0-85.0) kg, 88% were Black, and 49% were girls. First-line ART was initiated in 311 (44%) patients, of whom 92% were in the standard care group and received efavirenz-based ART. Of 396 (56%) patients who started second-line ART, 98% were in the standard care group and received boosted protease inhibitor-based ART.
At 96 weeks, treatment failure occurred among 47 and 75 patients included in the dolutegravir and standard care groups, respectively (estimated probability, 0.14 vs 0.22; difference, -0.08; 95% CI, -0.14 to -0.03; P =.004). Of note, treatment effects for first- and second-line ART were found to be similar (P =.16 for heterogeneity). Among patients in the dolutegravir and standard care groups, 35 and 40 reported at least 1 severe adverse event, respectively (P =.53), and 73 and 86 patients reported at least 1 adverse event of grade 3 or higher, respectively (P =.24). In addition, 5 patients in the dolutegravir group and 17 patients in the standard-care group reported at least 1 ART-modifying adverse event (P =.01).
This study may have been limited by its open-label design.
According to the researchers, “the need for only  types of dolutegravir formulations across all weight bands in children [and adolescents,] and the availability of both formulations from generic drug companies will allow national programs to align treatment for children with that [of] adults, simplifying drug procurement.”
Turkova A, White E, Mujuru HA, et al. Dolutegravir as first- or second-line treatment for HIV-1 infection in children. N Engl J Med. Published online January 7, 2022. doi:10.1056/NEJMoa2108793