Dolutegravir based therapy superior to standard care for children with HIV: NEJM

Written By :  Dr. Shravani Dali
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2021-12-31 03:30 GMT   |   Update On 2021-12-31 03:30 GMT
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Dolutegravir-based ART was superior to standard care for children and adolescents with HIV-1 infection, according to a recent study published in the New England Journal of Medicine.

Children with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).

The researchers conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non–dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan–Meier method. Safety was assessed.

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The results of the study are:

From September 2016 through June 2018, a total of 707 children and adolescents who weighed at least 14 kg were randomly assigned to receive dolutegravir-based ART (350 participants) or standard care (357). The median age was 12.2 years (range, 2.9 to 18.0), the median weight was 30.7 kg (range, 14.0 to 85.0), and 49% of the participants were girls. By design, 311 participants (44%) started first-line ART (with 92% of those in the standard-care group receiving efavirenz-based ART), and 396 (56%) started second-line ART (with 98% of those in the standard-care group receiving boosted protease inhibitor–based ART). The median follow-up was 142 weeks. By 96 weeks, 47 participants in the dolutegravir group and 75 in the standard-care group had treatment failure (estimated probability, 0.14 vs. 0.22; difference, –0.08; 95% confidence interval, −0.14 to −0.03; P=0.004). Treatment effects were similar with first- and second-line therapies (P=0.16 for heterogeneity). A total of 35 participants in the dolutegravir group and 40 in the standard-care group had at least one serious adverse event (P=0.53), and 73 and 86, respectively, had at least one adverse event of grade 3 or higher (P=0.24). At least one ART-modifying adverse event occurred in 5 participants in the dolutegravir group and in 17 in the standard-care group (P=0.01).

Thus, the researchers concluded that in this trial involving children and adolescents with HIV-1 infection who were starting first- or second-line treatment, dolutegravir-based ART was superior to standard care.

Reference:

Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children by Anna Turkova, et al. published in the New England Journal of Medicine.

https://www.nejm.org/doi/full/10.1056/NEJMoa2108793


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Article Source : The New England Journal Of Medicine

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