Table 1.
Baseline characteristics prior to or by the time of study ARV regimen initiation
| Optimal N = 21 | Suboptimal N = 31 | P value | |
|---|---|---|---|
| Age at start of study ARV regimen (years), median [IQR] | 17 [15-18.7] | 16 [13.9-18.3] | 0.34 |
| Females, n (%) | 11 (52) | 18 (58) | 0.69 |
| Race, n (%) | 0.66 | ||
| African-American | 19 (90) | 28 (90) | |
| White | 2 (10) | 2 (7) | |
| Other (Interracial) | 0 (0) | 1 (3) | |
| # of Co-morbidities, median [IQR] | 3 [2-4] | 3 [2-4] | 0.31 |
| Presence of prior OIs, n (%) | 16 (76) | 20 (65) | 0.37 |
| Presence of prior hospitalizations related to HIVa, n (%) | 4 (19) | 3 (10) | 0.33 |
| # HIV provider visits, mediana, b [IQR] | 3 [2-5] | 3 [2-4] | 0.42 |
| Documented non-adherence prior to the initiation of study ARV regimen, n (%) | 11/21 (52) | 17/29 (59) | 0.66 |
| CD4 (cells/mm3), median [IQR] | 471 [208-676] | 588 [403-1077] | 0.09 |
| CD4 nadir (cells/mm3), median [IQR] | 130 [26-304] | 266 [37-351] | 0.53 |
| VL log10c (copies/mL), median [IQR] | 3.07 [1.69-3.80] | 2.56 [1.69-3.23] | 0.23 |
| Patients with VL < 400 copies/mL, n (%) | 8 (38) | 18 (58) | 0.26 |
| CDC Classification, n (%) | 0.72 | ||
| A | 4 (19) | 5 (16) | |
| B | 4 (19) | 9 (29) | |
| C | 13 (62) | 17 (55) | |
| Study regimen rationale documented, n (%) | 0.57 | ||
| Resistanced | 7 (34) | 5 (16) | |
| Regimen simplificatione | 5 (23) | 5 (16) | |
| Adverse drug effects | 2 (10) | 4 (13) | |
| Pill burden reduction | 1 (5) | 5 (16) | |
| Unknown | 5 (23) | 10 (32) | |
| Otherf | 1 (5) | 2 (7) | |
| Patients with presence of RT resistance mutations, n (%) | 21 (100) | 31 (100) | N/A |
| Patients with presence of PR resistance mutations, n (%) | 19 (90) | 29 (94) | 0.68 |
| ARV class(es) of resistance, n (%) | 0.37 | ||
| 1 | 5 (24) | 6 (19) | |
| 2 | 5 (24) | 12 (39) | |
| 3 | 11 (52) | 11 (36) | |
| ≥ 4 | 0 (0) | 2 (6) | |
| #ARV class(es) exposure, median [IQR] | 3 [2-3] | 3 [3-3] | 0.28 |
| #ARV agent(s) exposure, median [IQR] | 8 [5-8] | 8 [7-9] | 0.25 |
| NNRTI based study ARV regimeng, n (%) | 7 (33) | 19 (61) | 0.09 |
| PI based study ARV regimenh, n (%) | 6 (29) | 8 (26) | 0.83 |
| DRV/r + RAL + ETR regimen, n (%) | 6 (29) | 0 (0) | 0.01 |
| Otheri, n (%) | 2 (9) | 4 (13) | 0.71 |
Preceding 12 months
Excluding visits with case manager, social worker, or for laboratory work
Actual VL values were used except patients with VL < 50, < 400, and > 100,000 copies/mL (VL 49, 399, and 100,001 copies/mL were substituted respectively).
Based on genotype testing interpreted by HIV provider documented in the medical records
Including changing regimen to reduced daily dosing frequency
Optimal arm: 1 patient due to drug-drug interaction and drug-disease interaction; suboptimal arm: 1 patient due to adverse drug effect and adherence problem, and 1 patient due to taking the medication incorrectly.
NNRTI based regimen excludes any PI agents
PI based regimen excludes any NNRTI agents
Optimal arm: 1 RAL + PI + NRTI, 1 PI + NNRTI + NRTI; suboptimal arm: 1 RAL + NNRTI + 3NRTIs, 1 RAL + PI + 2NRTIs, 2 PIs + NNRTI + NRTI.
ARV = antiretroviral, DRV/r = darunavir/ritonavir, ETR = etravirine, IQR = interquartile range, N/A = not applicable, NNRTI = non-nucleoside reverse transcriptase inhibitor, NRTI = nucleoside/nucleotide reverse transcriptase inhibitor, OI = opportunistic infection, PI = protease inhibitor, PR = protease gene, RAL = raltegravir, RT = reverse transcriptase, VL = viral load
Note: bolded value represents significant finding.