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Background:  Treatment interruption is a potential option for HIV⁺ adults with low viral load, high CD4, and CD4 nadir > 200/mm³. Little data exist on treatment interruption in children. Our objective was to describe clinical, immunologic, and virologic outcomes in HIV-infected children interrupting and reinitiating therapy in our center.

Method:  Treatment interruption has been offered since 2000 to clinically stable patients with CD4 > 500/mm³ (> 20%) and CD4 nadir > 200/mm³. HAART was resumed for clinical indications, when CD4 fell to < 350/mm³ or < 15% or viral load increased to > 250,000 copies/mL.

Results:  A total of 16 patients (42% of patients on ART) received treatment interruption (aged 3 to 15 years, median 7 years). Of the 16 children, 14 were at CDC clinical stage A or B, immunologic stage 1 or 2. Median duration of prior ART was 5 years. Additional reasons to stop therapy included ART toxicity (metabolic 3, cardiac 1, sleep disturbance 1), suboptimal therapy (resistance or dual regimen). Treatment interruption resulted in resolution of toxic effects, improved appetite and sense of well-being, and accelerated weight gain in 8 of the 16 (50%) children. None of the children showed clinical deterioration or opportunistic infections during treatment interruption; 9 (56%) resumed ART after a median of 22 months, while 7 (44%) remain on treatment interruption after a median of 38 months. Children who could interrupt treatment for > 2 years had higher CD4 nadir before treatment interruption than those who interrupted treatment < 2 years (median 930/mm³ vs 560/mm³). During treatment interruption, CD4 declined from median 970/mm³ to 800/mm³ after 6 months (n = 16), 900/mm³ after 12 months (n = 12), 890/mm³ after 24 months (n = 9), and 780/mm³ after 36 months (n = 5). Viral load increased by a median of 1 log by 6 months, and then remained stable. HAART was resumed after CD4 decline (8 of 9 patients) or viral load increase (1 of 9 patient):  viral load fell to < 50 copies/mL in all patients after < 4 months of HAART and CD4 increased by a median of 140/mm³ after 3 to 12 months (n = 7) and 250/mm³ after ≥ 2 years (n = 4).

Conclusions:  During treatment interruption we observed no adverse effects, slow CD4 decline, resolution of toxic effects, and improved appetite and weight gain. Of this group, 44% continue on treatment interruption after a median of > 3 years. All children requiring reinitiation of HAART achieved complete viral load suppression after < 4 months. Treatment interruption is a safe option for selected, clinically stable, immune competent HIV-infected children, provided they have careful clinical and laboratory monitoring.

Keywords: children ; antiretroviral therapy; interruption