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Background: There are conflicting data on time to switch from first-line to second-line ART in children. Here we present the first global estimates.
Methods: Individual-level data were pooled from 12 cohort networks within CIPHER. Children aged < 18-years initiating combination ART (≥2 nucleoside reverse-transcriptase inhibitors (NRTI) plus non-NRTI (NNRTI) or boosted protease inhibitor (PI)) were included. Switch to second-line was defined as: (i) change of ≥1 NRTI plus either change in drug class (NNRTI to PI or vice versa) or PI change; (ii) change from single to dual PI; or (iii) addition of new drug class. Cumulative incidence curves assessed time to switch, with death and loss to follow-up (LTFU) as competing risks.
Results: Of 95,194 children included, 18% were from South Africa and 72% from rest of Sub-Saharan Africa (SSA). At ART start, median [IQR] age was 3.7[1.6-6.8]years, CD4% 15%[9-21%], 42% had AIDS, 89% and 11% initiated NNRTI-based and PI-based ART, respectively. Median duration of follow-up from ART initiation was 26[9-51] months; 1% died, 26% were LTFU and 20% transferred out. Overall 4266 (4.5%) switched to second-line at median of 33.8[18.5, 55.1] months. The proportion switching at 3-years after ART start varied significantly across regions from 1.6% (95% CI 1.5,1.7) in SSA to 26.8% (20.6,33.3) in North America (Figure). A higher incidence of switch was seen in children aged≥10yrs at ART start compared to younger children in all regions except North America, in settings with routine viral load monitoring, and in children initiating NNRTI-based ART compared to PI-based ART in all regions except SSA.

Figure. Cumulative incidence of switch at 3 years of ART by age at start of ART, initial regimen and monitoring strategy by region
[Figure. Cumulative incidence of switch at 3 years of ART by age at start of ART, initial regimen and monitoring strategy by region]


Conclusions: We found wide regional variations in the cumulative incidence of switch to second-line, with higher incidence among children initiating ART aged≥10 years and those in settings with routine viral load monitoring. High rates of transfer and LTFU mean these estimates maybe the lower bound of the true switch rates.