Table 1.
Participant and HIV-1 Disease Characteristics Among A5202 Participants With Virologic Failure With HIV-1 Genotype Results
| EFV + TDF/FTC (n = 54) | EFV + ABC/3TC (n = 71) | ATV/r + TDF/FTC (n = 57) | ATV/r + ABC/3TC (n = 83) | Total (N = 265) | ||
|---|---|---|---|---|---|---|
| Pretreatment characteristics | ||||||
| Sex | Male | 45 (83%) | 60 (85%) | 38 (67%) | 64 (77%) | 207 (78%) |
| Age (y) | Median (Q1, Q3) | 39 (30, 43) | 32 (27, 40) | 39 (30, 45) | 35 (30, 42) | 35 (29, 43) |
| Race/ethnicitya | Black non-Hispanic | 26 (48%) | 31 (44%) | 34 (60%) | 36 (43%) | 127 (48%) |
| White non-Hispanic | 18 (33%) | 27 (38%) | 15 (26%) | 25 (30%) | 85 (32%) | |
| Hispanic | 10 (19%) | 10 (14%) | 8 (14%) | 18 (22%) | 46 (17%) | |
| Hepatitis C antibody | Positive | 9 (17%) | 3 (4%) | 6 (11%) | 6 (7%) | 24 (9%) |
| Screening HIV-1 RNA stratum | ≥100 000 | 22 (41%) | 33 (46%) | 28 (49%) | 48 (58%) | 131 (49%) |
| Plasma HIV-1 RNA (log10 copies/mL) | Median (Q1, Q3) | 4.7 (4.3, 5.0) | 4.8 (4.2, 5.5) | 4.6 (4.3, 4.9) | 4.8 (4.5, 5.5) | 4.7 (4.4, 5.3) |
| CD4+ T-cell count (cells/μL) | Median (Q1, Q3) | 197 (51, 308) | 185 (20, 324) | 253 (79, 360) | 90 (32, 320) | 188 (38, 330) |
| Genotype before screening | Genotyped | 21 (39%) | 33 (46%) | 16 (28%) | 40 (48%) | 110 (42%) |
| Major resistance mutations | Yes | 7 (13%) | 8 (11%) | 3 (5%) | 7 (8%) | 25 (9%) |
| Number of codons with amino acid mixtures | Mean (SD) | 2.4 (2.4) | 2.1 (1.9) | 1.7 (1.5) | 2.1 (1.7) | 2.1 (1.9) |
| Median (Q1, Q3) | 2 (0, 4) | 2 (0, 4) | 2 (1, 3) | 2 (1, 3) | 2 (1, 3) | |
| Closest subtype cladeb | Subtype B | 51 (94%) | 68 (96%) | 56 (98%) | 79 (95%) | 254 (96%) |
| At the time of virologic failure | ||||||
| Plasma HIV-1 RNA (log10 copies/mL) | Median (Q1, Q3) | 3.6 (2.8, 4.3) | 3.9 (3.2, 4.7) | 3.7 (2.8, 4.5) | 3.5 (2.8, 4.3) | 3.6 (2.9, 4.5) |
| Major resistance mutationsc | Yes | 34 (63%) | 48 (68%) | 7 (12%) | 19 (23%) | … |
| K103N and M184V/I | Both | 8 (15%) | 17 (24%) | 0 (0%) | 2 (2%) | … |
| K103N without M184V/I | 16 (30%) | 17 (24%) | 0 (0%) | 0 (0%) | … | |
| M184V/I without K103N | 3 (6%) | 9 (13%) | 5 (9%) | 12 (14%) | … | |
| Antiretroviral adherence self-reportd | 100% adherent | 37 (69%) | 42 (60%) | 33 (58%) | 52 (63%) | 164 (62%) |
| <100% adherent | 7 (13%) | 9 (13%) | 13 (23%) | 17 (21%) | 46 (17%) | |
| Not taking any antiretroviral treatment | 10 (19%) | 19 (27%) | 11 (19%) | 13 (16%) | 53 (20%) | |
| Days between initial failure and genotype specimens | Median (Q1, Q3) | 28 (17, 56) | 28 (14, 62) | 35 (21, 80) | 28 (19, 57) | 28 (19, 62) |
| Assigned antiretroviral treatment status | No modification | 38 (70%) | 42 (59%) | 47 (82%) | 55 (66%) | 182 (69%) |
| Restricted to ≥100 000 screening stratum | Virologic failure after DSMB recommendation | 11/22 (50%) | 8/33 (24%) | 13/28 (46%) | 16/48 (33%) | 48/131 (37%) |
Data are presented as no. (%) unless otherwise specified.
Abbreviations: ABC/3TC, abacavir/lamivudine; ATV/r, atazanavir/ritonavir; DSMB, data safety and monitoring board; EFV, efavirenz; HIV-1, human immunodeficiency virus type 1; Rx, treatment; TDF/FTC, tenofovir DF/emtricitabine.
a n = 7 have other race/ethnicity.
b Other observed subtypes included: A1 (n = 4), AG (n = 3), F2 (n = 2), C (n = 1), and D (n = 1).
c Includes participants with and without pretreatment resistance.
d Self-report 1 week recall, most recent report prior to virologic failure genotype sample, n = 2 with missing data.