Virologic Outcomes and ARV Switch Profiles 2 Years After National Rollout of Dolutegravir to Children Less Than 15 Years in Southern Mozambique.

Abstract

Dolutegravir (DTG) was scaled up globally to optimize treatment for children living with HIV. We evaluated the rollout and virological outcomes after DTG introduction in Mozambique. Data from children 0-14 years with visits from September 2019 to August 2021 were extracted from records in 16 facilities in 12 districts. Among children ever on DTG, we report treatment switches, defined as changes in anchor drug, regardless of changes to nucleoside reverse transcriptase inhibitor (NRTI) backbones. Among those on DTG for ≥6 months, we described viral load suppression rates by children newly initiating and switching to DTG and by the NRTI backbone at the time of the DTG switch. Overall, 3,347 children were ever on DTG-based treatment (median age 9.5 years; 52.8% female). Most children (3,202, 95.7%) switched to DTG from another antiretroviral regimen. During the 2-year follow-up, 9.9% never switched from DTG; 52.7% had 1 regimen change, of which 97.6% were switched to DTG. However, 37.2% of children experienced ≥2 anchor drug changes. Overall median time on DTG was 18.6 months; nearly all children ≥5 years (98.6%) were on DTG at the last visit. Viral suppression was 79.7% (63/79) for children newly initiating DTG and 85.8% (1,775/2,068) for those switching to DTG. Suppression rates were 84.8% and 85.7% among children who switched and maintained NRTI backbones, respectively. Viral suppression rates of ≥80% with minor variations by backbone were achieved during the 2-year DTG rollout. However, there were multiple anchor drug switches for over one-third of children, which may be attributable in part to drug stockouts. Long-term pediatric HIV management will only be successful with immediate and sustainable access to optimized child-friendly drugs and formulations.