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Title
Longitudinal lymphocyte dynamics in virologically suppressed children with HIV initiating single-tablet elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (E/C/F/TAF)
Presenter
Natella Rakhmanina
Authors
N. Rakhmanina1,2,3, E. Natukunda4, R. Strehlau5, E. Hellstrӧm6, A. Liberty7, S. Crowe8, V.A. Vieira8, K. Kersey8, A.H. Gaur9, P. Kosalaraksa10
Institutions
1Children’s National Hospital, Washington, D.C., United States, 2The George Washington University, Washington, D.C., United States, 3Elizabeth Glaser Pediatric AIDS Foundation, Washington D.C., United States, 4Joint Clinical Research Centre, Kampala, Uganda, 5University of the Witwatersrand, Johannesburg, South Africa, 6Be Part Yoluntu Centre, Paarl, South Africa, 7Chris Hani Baragwanath Hospital, Johannesburg, South Africa, 8Gilead Sciences, Inc., Foster City, United States, 9St Jude Children's Research Hospital, Memphis, United States, 10Khon Kaen University, Khon Kaen, Thailand

BACKGROUND: Lymphocyte counts fluctuate in young children, and several antiretroviral therapies have been associated with hematologic effects. We assessed lymphocyte dynamics in virologically suppressed children with HIV (age 2–<12 years) receiving elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (E/C/F/TAF) for 48 weeks.
METHODS: This analysis included virologically suppressed children with HIV from Cohorts 2 and 3 (C2 and C3) of a Phase 2/3 open-label study (NCT01854775). Children in C2 (age 6–<12 years, weight =25 kg) and C3 (=2 years, 14–<25 kg) received once-daily E/C/F/TAF for =48 weeks. Lymphocyte populations were analyzed by flow cytometry of whole blood, using anti-CD3, CD4, CD8, CD16, CD19 and CD56 panel of antibodies.
RESULTS: Overall, 79 participants were enrolled. In C2 (n=52) and C3 (n=27), respectively, median (interquartile range [IQR]) age was 10 (9, 11) and 6 (4, 8) years, 42% and 37% were male, and 71% and 89% were Black. Median (IQR) absolute lymphocyte counts (×103/µL) at baseline in C2 and C3 were 2.31 (1.92, 2.78) and 2.96 (2.39, 3.82), respectively; these decreased during treatment (particularly in C3), with changes of -0.04 (-0.67, 0.29) and -0.52 (-1.16, -0.05) at Week 48. There were also small decreases in median (IQR) absolute CD4 T-cell counts (cells/µL), with changes of -33 (-194, 80) and -187 (-370, 44) in C2 and C3, respectively, at Week 48. However, the relative proportion of CD4 T cells and the CD4/CD8 ratio remained stable during treatment. Changes in CD8 T-cell, B-cell and natural killer cell counts are shown in the Table.


CONCLUSIONS: Minor fluctuations in absolute lymphocyte subpopulation counts were observed over 48 weeks of E/C/F/TAF. The decline in absolute CD4 T-cell counts mirrors known physiological fluctuations in young children, mainly observed in those aged <6 years. No clinically relevant effects of E/C/F/TAF on lymphocytes were identified in this population.

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