Table 1:
Characteristics of participants on the day of ART initiation
| ART initiation | Intergroup comparisons | ||||||
|---|---|---|---|---|---|---|---|
| Acute (n=15) | Early (n=19) | Deferred (n=22) | Group-wise comparison p value | Acute vs early p value | Acute vs deferred p value | Early vs deferred p value | |
| Male sex assigned at birth | 15 (100%) | 19 (100%) | 22 (100%) | NS | NS | NS | NS |
| Age, years | 28 (25–30) | 27 (21–31) | 25 (21–30) | NS | NS | NS | NS |
| Time from EDDI to enrolment, days | 21 (18–23) | 43 (36–57) | 38 (27–57) | <0·0001 | <0·0001 | 0·0002 | NS |
| Time from EDDI to ART initiation, days | 21 (18–23) | 43 (36–57) | 206 (196–220) | <0·0001 | 0·0076 | <0·0001 | 0·0002 |
| CD4 cell count, cells per μL | 540 (296–598) | 388 (229–506) | 399 (315–565) | NS | NS | NS | NS |
| Percentage of CD4 cells | 26% (20–37) | 17% (11–23) | 24% (17–18) | 0·0053 | 0·0060 | NS | 0·054 |
| CD8 cell count, cells per μL | 775 (438–1119) | 1072 (635–1717) | 730 (566–920) | NS | NS | NS | NS |
| Percentage of CD8 cells | 44 (31–54) | 54 (48–72) | 41 (38–48) | 0·044 | NS | NS | 0·060 |
| CD4/CD8 ratio | 0·59 (0·41–1·01) | 0·33 (0·16–0·49) | 0·62 (0·34–0·68) | 0·015 | 0·017 | NS | 0·084 |
| ART regimen | ·· | ·· | ·· | NS | NS | NS | NS |
| Efavirenz, emtricitabine, and tenofovir disoproxil fumarate | 10 (67%) | 14 (74%) | 16 (73%) | ·· | ·· | ·· | ·· |
| Elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate | 3 (20%) | 5 (26%) | 6 (27%) | ·· | ·· | ·· | ·· |
| Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide | 2 (13%) | 0 | 0 | ·· | ·· | ·· | ·· |
| Viral load, log10 HIV copies per mL of plasma | 6·8 (6·4–7·1) | 5·96 (5·07–6·31) | 4·64 (4·27–5·23) | <0·0001 | 0·056 | <0·0001 | 0·0074 |
| Total HIV DNA | 9 (60%) | 14 (74%) | 19 (86%) | ·· | ·· | ·· | ·· |
| Log10 ([HIV copies per 10⁶ CD4 cells] + 1) | 3·83 (3·45–3·99) | 3·67 (3·24–4·13) | 3·40 (2·81–3·72) | 0·048 | NS | 0·091 | NS |
| Integrated HIV DNA | 9 (60%) | 14 (74%) | 19 (86%) | ·· | ·· | ·· | ·· |
| log10 ([HIV copies per 10⁶ CD4 cells] + 1) | 2·87 (2·80–3·26) | 2·76 (2·24–3·20) | 2·55 (2·23–2·97) | NS | NS | NS | NS |
| 2-LTR circles | 9 (60%) | 14 (74%) | 19 (86%) | ·· | ·· | ·· | ·· |
| log10 ([HIV copies per 10⁶ CD4 cells] + 1) | 3·07 (2·75–3·27) | 2·64 (1·87–2·95) | 1·81 (0·51–2·41) | 0·0003 | NS | 0·0002 | NS |
| TILDA ex vivo | 5 (33%) | 10 (53%) | 18 (82%) | ·· | ·· | ·· | ·· |
| frequency of CD4 cells with msRNA per million cells | 2·77 (1·17–2·95) | 1·69 (1·10–2·21) | 1·14 (0·71–1·47) | 0·034 | NS | 0·055 | NS |
| TILDA after stimulation | 5 (33%) | 10 (53%) | 17 (77%) | ·· | ·· | ·· | ·· |
| frequency of CD4 cells with msRNA per million cells | 2·94 (1·60–3·14) | 2·02 (1·80–2·56) | 1·66 (1·21–2·14) | 0·057 | NS | NS | NS |
Data are n (%) or median (IQR), unless otherwise specified. Acute initiation of ART was within 30 days or less of the EDDI, early initiation was at 30–90 days of the EDDI, and delayed initiation was at more than 24 weeks after the EDDI. Groups were compared with the Kruskall-Wallis test. ART=antiretroviral therapy. NS=not significant. EDDI=estimated date of detectable infection. 2-LTR=2-long terminal repeat. TILDA=tat/rev induced limiting dilution assay. msRNA=multiply-spliced RNA.