Similar Efficacy and Safety of Dolutegravir Between Age Groups of HIV-1-Infected Paediatric and Young Adult Patients Aged 5 Years and Older

P Frange; V Avettand-Fenoel; F Veber; S Blanche


HIV Medicine. 2019;20(8):561-566. 

In This Article

Abstract and Introduction


Objectives: The aim of the study was to carry out a comparison of the safety and efficacy of dolutegravir-based regimens among age groups of HIV-1-infected paediatric and young adult patients.

Patients and methods: This retrospective monocentric study included 109 patients infected since childhood who began receiving dolutegravir between January 2014 and December 2017. The patients were divided into three groups according to age at the time of dolutegravir initiation: 5–11, 12–17 and 18–25 years old. The primary endpoint was the proportion of patients achieving a plasma viral load (PVL) < 50 HIV-1 RNA copies/mL within 3 months of dolutegravir initiation (for patients with detectable viraemia at baseline), and maintaining virological suppression (PVL < 50 copies/mL) until the last follow-up visit (for all patients).

Results: Most of the subjects were antiretroviral-experienced (91.7%) and virologically suppressed at baseline (66.7%, 54.9% and 56.0% in the 5–11, 12–17 and 18–25 year age groups, respectively). Median follow-up was 24 months (range 6–54 months). Sustained virological success throughout follow-up was observed in 79.8% of patients, with similar rates among age groups (87.9%, 72.5% and 84.0%, respectively; P = 0.22). With reinforced measures to improve adherence, undetectable PVL was obtained at the last visit in 88.1% of patients, with similar proportions among age groups (93.9%, 84.3% and 88.0%, respectively; P = 0.51). No emergence of resistance mutations was observed in the 22 patients with virological failure. Dolutegravir was well tolerated; only one patient stopped treatment for severe drug-related side effects.

Conclusions: The virological efficacy and safety of dolutegravir were similar among the three age groups. Because of its high genetic barrier to resistance, dolutegravir could be especially useful in the paediatric population, in which the risk of poor treatment adherence is high.


Achieving good adherence to treatment and viral suppression in the long term remains challenging in paediatric and young adult patients living with HIV. Overall virological failure (VF) rates in this group are more than double those in adults, even in high-resource countries.[1]

Dolutegravir is a powerful, easy-to-take, well-tolerated integrase inhibitor (INI) for which there is a high genetic barrier to resistance and few drug–drug interactions have been reported.[2] Dolutegravir-based combinations are now approved for use in children aged ≥ 6 years. However, these guidelines were mainly supported by the extrapolation of efficacy data from trials involving adults and data about the efficacy and safety profile of dolutegravir in the paediatric population are scarce, especially in the youngest children.[3–8] Moreover, unpublished results of the P1093 study showed a high rate of VF (52.2%) among 12- to 17-year-old participants receiving dolutegravir and frequent emergence of INI resistance in children with VF,[8] contrasting with the virological results of studies involving adults.[9–11]

This retrospective monocentric study described the efficacy and safety of dolutegravir in patients followed in a French paediatric unit and compared data among three age groups at the time of dolutegravir initiation: 5–11 (group 1), 12–17 (group 2) and 18–25 (group 3) years old.