Table 2.
Characteristics by response group for bNAb-only treatment with VRC01LS and 10– 1074 in children living with HIV in Botswana.
| Baseline/Enrollment Characteristics | Total (N=25)a | Treatment Success on bNAbs (N=11) | Treatment Failure on bNAbs (N=14) | P-value |
|---|---|---|---|---|
| Median (IQR) or number (%) | ||||
| Age at ART start (days) | 3 (2–4) | 3 (3–5) | 2 (2–3) | 0.10 |
| Age at bNAb start (years) | 3.70 (3.10–4.40) | 4.20 (3.40–4.60) | 3.45 (2.90–4.40) | 0.26 |
| HIV-1 RNA at birth (copies/mL) | 3145 (310–25507) | 2279 (381–12984) | 20465 (292–33502) | 0.37 |
| HIV-1 RNA undetectable since 24 weeksb | ||||
| Yes | 13 (52%) | 9 (82%) | 4 (29%) | 0.02 |
| No | 12 (48%) | 2 (18%) | 10 (71%) | |
| Total HIV DNA in PBMCs at birth by ddPCR (copies/106)c | 465 (100–1129) | 155 (46–465) | 784 (166–1246) | 0.02 |
| Intact HIV DNA in PBMCs at birth by FLIP-seq (copies/106)c | 2.9 (0.22–280.4) | 1.16 (0.22–38.3) | 4.59 (0.52–280.4) | --d |
| Number with intact HIV DNA in PBMCs at birth by FLIP-seq (for those >L.O.D.) | 18 (72%) | 6 (55%) | 12 (86%) | 0.18 |
| Intact HIV DNA in PBMCs at Tatelo entry by FLIP-seq (copies/106)c | 0.24 (0.04–2) | 0.26 (0.04–2) | 0.22 (0.08–1) | --d |
| Number with intact HIV DNA in PBMCs at Tatelo entry by FLIP-seq (for those >L.O.D.) |
5 (20%) | 2 (18%) | 3 (21%) | >0.99 |
| Negative whole blood qualitative HIV DNA PCR and HIV enzyme immunoassay at Tatelo entry | ||||
| Yes | 8 (32%) | 8 (73%) | 0 | <0.001 |
| No | 17 (68%) | 3 (27%) | 14 (100%) | |
| Amount of bNAb/ART Overlap | ||||
| 32 weeks | 6 (24%) | 5 (45%) | 1 (7%) | 0.06 |
| 8 weeks | 19 (76%) | 6 (55%) | 13 (93%) | |
| CD4 T cell count (cells/mm3) | ||||
| Start of bNAb-only treatment | 1149 (922–1502) | 984 (808–1185) | 1380 (1004–1868) | 0.05 |
| bNAb susceptibilitye | ||||
| 10–1074 susceptible (PBMCs at birth) | 8 (57%) | 6 (100%) | 2 (25%) | 0.01 |
| VRC01LS susceptible (PBMCs at birth) | 7 (50%) | 3 (50%) | 4 (50%) | >0.99 |
a
Excludes 3 children who began bNAbs but never discontinued ART.
b
Defined as all visits at or after 24 weeks of age with HIV-1 RNA <40 copies/mL; per protocol, all HIV-1 RNA values in the 24 weeks prior to bNAb initiation must be <40 copies/mL.
c
An imputed value of 1 provirus in double the number of analyzed cells used if no target identification.
d
Low sample size and high proportion below the L.O.D. precluded comparison of distributions.
e
N=14 (8 treatment failures, 6 treatment successes) with amplification. bNAb susceptibility was based on maximum percent inhibition (MPI) ≥98%.