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Preeminence of Dolutegravir-Based Antiretroviral
Therapy in Children and Adolescents
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Carlos del Rio, MD, reviewing Turkova A et al. N Engl J Med 2021 Dec 30
Dolutegravir-based antiretroviral therapy was superior to other regimens in children and teens with HIV-1 infection who were starting first- or second-line ART.
Dolutegravir (DTG) was designated by WHO as a preferred drug for first- and second-line ART in 2018 - and while HIV integrase strand-transfer inhibitors have proven superiority in adults, data in children and adolescents are more limited. Now, in an open-label, randomized noninferiority trial, investigators assessed the efficacy and safety of DTG-based ART compared with non–DTG-based ART in children and teens with HIV-1 infection who were starting therapy or switching to second-line therapy after treatment failure (median age, 12.2 years; median weight, 30.7 kg; 88% from three southern African countries). Among 707 participants in the final analysis (311 starting ART and 396 switching to second-line ART), 350 were randomized to DTG and 357 to non-DTG. Standard of care for those initiating treatment was predominantly efavirenz-based ART, and for those switching to second-line ART, a boosted protease inhibitor.
By week 96, treatment failure occurred in 47 participants in the DTG arm (15 starting ART; 32 in second-line therapy) and 75 in the standard care arm (34 starting ART; 41 in second-line therapy). Treatment outcome was unaffected by sex, age, weight, baseline CD4, or viral load. Adverse events were similar in both groups.
Comment
Starting DTG as part of the initial ART regimen or using it as second-line therapy in children and adolescents with HIV-1 infection was superior to standard of care. As it is in adults, DTG-based ART should be the preferred regimen in children and teens.
NEJM full text
Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children - (01/03/22)
Citation(s):
Turkova A et al. Dolutegravir as first- or second-line treatment for HIV-1 infection in children. N Engl J Med 2021 Dec 30; 385:2531. (https://doi.org/10.1056/NEJMoa2108793)
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