Table 1.
Baseline Characteristics, Directly Observed Therapy (DOT) Results, and Treatment Outcomes in Study Participants, Overall and by DOT Treatment Response
| Characteristic, Result, or Outcome | Participants, No. (%)a | P Valueb | ||
|---|---|---|---|---|
| Overall (N = 20) |
DOT1-Rs (n = 9) |
DOT1-NRs (n = 11) |
||
| Demographics | ||||
| Age, median (IQR), y | 45.5 (26.0–51.3) | 26.0 (24.0–47.0) | 49.0 (42.5–51.5) | .09 |
| Male sex | 12 (60.0) | 4 (44.4) | 8 (72.7) | .26 |
| Black race | 17 (85.0) | 8 (88.9) | 9 (81.2) | >.99 |
| Post–high school education | 14 (70.0) | 4 (44.4) | 10 (90.9) | .03 |
| Unemployed | 7 (35.0) | 5 (55.6) | 2 (18.2) | .12 |
| Housing instability | 5 (25.0) | 5 (55.6) | 0 (0.0) | .005 |
| Food insecurity | 3 (15.0) | 3 (33.3) | 0 (0.0) | .052 |
| Mental health concerns | 8 (40.04) | 6 (66.7) | 2 (18.2) | .06 |
| Current alcohol use | 10 (50.0) | 4 (44.4) | 6 (54.5) | >.99 |
| Illicit drug use | 6 (30.0) | 3 (33.3) | 3 (27.3) | >.99 |
| Previous drug use | 11 (55.0) | 6 (66.7) | 5 (45.5) | .38 |
| HIV risk factor | ||||
| MSM | 8 (40.0) | 2 (22.2) | 6 (54.5) | .16 |
| Heterosexual | 7 (35.0) | 3 (33.3) | 4 (36.4) | |
| Perinatal | 5 (25.0) | 4 (44.4) | 1 (9.1) | |
| Screening results | ||||
| VL, median (IQR), log10 copies/mL | 4.46 (4.32–5.00) | 4.35 (4.17–4.51) | 4.64 (4.36–5.00) | .33 |
| CD4 cell count, median (IQR), cells/μL | 54.0 (13.8–90.3) | 66.0 (26.0–89.0) | 50.0 (10.5–82.0) | .57 |
| CD4 cell count <200/μL | 18 (90.0) | 9 (100.0) | 9 (81.2) | .38 |
| ART experience and resistance | ||||
| Time since diagnosis, mean (SE), y | 21.3 (7.0) | 20.7 (7.4) | 21.8 (7.0) | .72 |
| Time on ART, mean (SE), y | 17.2 (6.1) | 14.2 (6.1) | 19.6 (5.2) | .047 |
| No. of ART drugs, mean (SE) | 11.8 (4.5) | 8.8 (3.7) | 14.3 (3.6) | .004 |
| Prior mono- or dual-NRTI therapy | 5 (25.0) | 1 (11.1) | 4 (36.4) | .22 |
| Prior T-20 or maraviroc salvage therapy | 6 (30.0) | 1 (11.1) | 5 (45.5) | .10 |
| Total no. of major and minor DRMs by ARV drug class, median (IQR)c | 14 (5.0–18.0) | 5.0 (3.0–7.0) | 18.0 (14.5–19.0) | <.001 |
| Total no. of DRMs by ARV drug class, median (IQR) | 20.5 (7.5–24.0) | 6.0 (5.0–12.0) | 24.0 (21.5–25.5) | .001 |
| NRTI DRMs | 4.5 (1.0–7.0) | 1.0 (1.0–2.0) | 6.0 (5.0–7.0) | .003 |
| NNRTI DRMs | 3.0 (1.8–4.0) | 2.0 (1.0–3.0) | 4.0 (3.0–5.0) | .016 |
| PI DRMs | 9.0 (3.0–12.3) | 3.0 (2.0–6.0) | 11.0 (10.0–14.0) | .001 |
| INSTI DRMs | 1.0 (0.0–3.0) | 0.0 (0.0–0.0) | 3.0 (1.5–3.0) | .002 |
| GSS,d median (IQR) | 1.0 (0.1–2.0) | 2.0 (2.0–2.6) | 0.1 (0.0–0.3) | <.001 |
| ART daily pill burden, median (IQR) | 3.5 (2.0–5.0) | 3.0 (2.0–5.0) | 4.0 (2.5–5.5) | .24 |
| Total daily pill burden, median (IQR) | 10.0 (6.0–12.0) | 7.0 (5.8–11.5) | 10.0 (9.3–11.8) | .49 |
| DOT results | ||||
| VL change from screening to DOT d 8, median (IQR), log10 copies/mL | −0.22 (−1.51 to −0.08) | −1.52 (−1.47 to −1.96) | −0.10 (−0.09 to 0.14) | <.001 |
| Participants who requested <100% of DOT ART doses | 8 (40.0) | 3 (33.3) | 5 (45.5) | .60 |
| Post-DOT treatment outcomes, for participants with ≥6-mo follow-up | (n=17) | (n=6) | (n=10) | |
| VL <40 copies/mL achieved (with >6-mo follow-up) at ≥1 study time point | 11 (64.7) | 5 (83.3) | 6 (60.0)e | .42 |
| Maintained VL <40 copies/mL for 6 mo (>6-mo follow-up) | 5 (29.4) | 1 (16.7) | 3 (30.0) | >.99 |
| CD4 cell count increased between screening and 6 mo later | 13/16 (81.3) | 6 (100.0) | 7 (70.0) | .16 |
Abbreviations: ART, antiretroviral therapy; ARV, antiretroviral; DOT, directly observed therapy; DOT-NRs, DOT nonresponders; DOT-Rs, DOT responders; DRMs, drug resistance mutations; GSS, genotypic susceptibility score; HIV, human immunodeficiency virus; INSTI, integrase strand transfer inhibitor; IQR, interquartile ratio; MSM, men who have sex with men; NNRTI, nonnucleoside reverse-transcriptase inhibitor; NRTI, nucleoside reverse-transcriptase inhibitor; PI, protease inhibitor; SE, standard error; T-20, enfuvirtide; VL, viral load.
aData represent no. (%) of participants unless otherwise specified.
bDOT-R and DOT-NR parameters were compared by means of 2-sample t test for normally distributed continuous variables, Mann-Whitney U test for variables that were not normally distributed, and Boschloo’s test for binary variables.
cAccording to the 2017 International AIDS Society–USA mutation list [6].
dGSSs range from 0 (no ARV agents with activity) to 3 (3 fully active ARV agents in regimen).
eEight DOT-NRs switched to optimized ARV regimens after the first DOT. The virologic responses reflect response while on the new optimized ARV regimen.