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

Abstract

Background: 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. Methods: 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. Results: 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. Conclusions: 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.

Consistency of Multi-Month Antiretroviral Therapy Dispensing and Association with Viral Load Coverage among Pediatric Clients Living with HIV in Mozambique

“…The study period also coincided with the rollout of new pediatric drug formulations and treatment guidelines, during which time children who had been receiving a 3-month supply were offered a single month only of the new regimen before returning to the 3-month supply after an acceptability assessment. Other analyses of this cohort found that 88% of children aged 5 years and older had at least one regimen switch during the study period [30]. These switches may have contributed to more frequent clinical…”

HIV viral suppression in children and adolescents 2 years after transition to dolutegravir: a multicentre cohort study

“…In studies in Kenya and at Baylor sites in Botswana, Eswatini, Lesotho, Malawi, Tanzania, and Uganda [ 23 , 33 ], the authors reported viral suppression rates of 93.4–95.8% when applying a threshold of 1000 copies/ml, where in our study, 96.1% had a viral load less than 1000 copies/ml at 24 months. However, other studies have reported lower viral suppression rates after transition to dolutegravir (Mozambique: 76.2% [ 25 ]; Tanzania: 82.5% [ 34 ]), raising questions about the comparability of HIV programs and its populations in sub-Saharan Africa [ 35 ].…”

“…Real-world outcomes among adults appear promising [16–21]. However, observational studies describing paediatric treatment outcomes after the rollout of dolutegravir are currently scarce [18,22–25].…”