Dolutegravir is a potent and well-tolerated medication with fewer side effects and lower overall incidence of adverse events compared to other regimens. It is also associated with fewer drug interactions, making it easier to administer with most commonly used medications. Children who are HIV positive will have access to this new medication, and it is expected to improve health outcomes for them by suppressing the viral load quickly, which reduces the risk of transmission and prevents the development of drug resistance.
A study published in The Lancet HIV in 2019 evaluated the safety and tolerability of dolutegravir in 16-week-old to 18-year-old children and adolescents living with HIV, and found that dolutegravir was generally safe and well-tolerated, with no new safety concerns identified. A further study, published in The New England Journal of Medicine in 2019, compared the efficacy of dolutegravir with that of the standard of care (efavirenz-based regimens) in children and adolescents living with HIV. The study found that dolutegravir was non-inferior to the standard of care in terms of virologic suppression, with a higher proportion of participants achieving viral suppression in the dolutegravir group.
Dolutegravir use in children, especially in young children and newborns, has raised some concerns. This is due to the possible risk of neural tube defects (NTDs) in children conceived by mothers who were on dolutegravir. NTDs are birth defects that can have major health implications and cause damage to the brain, spine, or spinal cord.
Because of this, the World Health Organization (WHO) initially advised against using dolutegravir in women who might become pregnant unless they were also using an effective form of contraception. The risk of NTDs may, however, be lower than previously believed, and the WHO has amended its recommendations to propose that dolutegravir be used in all populations, including women of childbearing age.