Dolutegravir safe, effective in paediatric HIV

Use of dolutegravir (DTG) proves to be effective and safe in children and adolescents living with HIV (CALHIV) in low- and middle-income countries (LMICs), as shown in a study.

This retrospective analysis was conducted among CALHIV aged 0‒19 years and weighing ≥20 kg who received DTG from 2017 to 2020 at sites in Botswana, Eswatini, Lesotho, Malawi, Tanzania, and Uganda. The investigators then assessed the effectiveness, safety, and predictors of viral load suppression (VLS) in this population of DTG users, including single drug substitutions (SDS).

A total of 9,419 CALHIV on DTG were included, of whom 7,898 had a documented post-DTG viral load. Some 7,378 individuals (93.4 percent) achieved VLS post-DTG.

VLS for antiretroviral therapy (ART) initiations was achieved by 246 out of 263 CALHIV (92.4 percent) and was maintained among ART users (92.9 percent [7,026/7,560] pre- vs 93.5 percent [7,071/7,560] post-DTG; p=0.14). Among those with previously unsuppressed viral load, 426 out of 534 (79.8 percent) achieved VLS with DTG treatment.

Grade 3 or 4 adverse events leading to DTG discontinuation occurred in five patients (0.057 per 100 patient-years).

Factors associated with achieving VLS post-DTG were history of protease inhibitor-based ART (odds ratio [OR], 1.53, 95 percent confidence interval [CI], 1.16‒2.03), care in Tanzania (OR, 5.45, 95 percent CI, 3.41‒8.70), and 15‒19 years of age (OR, 1.31, 95 percent CI, 1.03‒1.65).

Notably, VLS before DTG (OR, 3.87, 95 percent CI, 3.03‒4.95) and using the once-daily, single tab tenofovir-lamivudine-DTG regimen (OR, 1.78, 95 percent CI, 1.43‒2.22) predicted VLS on DTG.

In addition, SDS maintained VLS (95.9 percent [2,032/2,120] pre- vs 95.0 percent [2,014/2,120] post-SDS with DTG; p=0.19). Seventy-three of 88 (83.0 percent) unsuppressed individuals achieved VLS using SDS with DTG.

“These findings can empower clinicians to prescribe DTG confidently to eligible CALHIV,” the investigators said.