Dolutegravir based ART superior to standard care in treating Children with HIV-1 Infection

Dr Anna Turkova and the team has found in a new study that dolutegravir-based ART for children and adolescents with HIV-1 infection has unveiled a game-changing advancement in HIV treatment, claiming to be superior to standard care. The findings were published in The New England Journal of Medicine.

The study aimed to assess the safety and estimate the primary endpoint by proportioning the participants with virologic or clinical treatment failure by 96 weeks using the Kaplan–Meier method.

A total of 707 children and adolescents (aged 2.9 to 18.0 years, weighing at least 14 kg) were enrolled from September 2016 through June 2018. They were randomly assigned to receive either dolutegravir-based ART (350 participants) or standard care (357 participants).

The study highlights:

• 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 the 96-week, only 47 participants in the dolutegravir group experienced treatment failure (0.14), compared to 75 in the standard care group (0.22). The significant difference reported is P=0.004.
• The benefits of dolutegravir-based ART were consistent across both first- and second-line therapies (P=0.16 for heterogeneity).
• Dolutegravir-based ART poses no more significant risks than standard care (P=0.53 for serious adverse events; P=0.24 for adverse events of grade 3 or higher).
• Participants in the dolutegravir group experienced significantly fewer ART-modifying adverse events than those in the standard care group (P=0.01).

This finding demonstrates the superiority of dolutegravir over standard care, as the safety profiles of the two treatments were comparable. At the same time, dolutegravir-based ART exhibited a notable advantage with fewer ART-modifying adverse events, regardless of their treatment history, with significantly lower rates of treatment failure.

Thus, dolutegravir-based ART is revolutionizing paediatric HIV treatment by improving outcomes and quality of life for children and adolescents with HIV-1 infection.

References:

Turkova A, White E et al. “Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children.” The New England Journal of Medicine.Publish on December 30, 2021

DOI: 10.1056/NEJMoa2108793