Table 2.
Characteristics of Study Participants at Initiation of Antiretroviral Therapy and at First-line Virologic Failure by Study
| Characteristic | Statistics/Levels | A5142 (N = 67) | A5202 (N = 107) | A5208 (N = 35) | Overall (N = 209) |
|---|---|---|---|---|---|
| Characteristics prior to starting ART | |||||
| Sex | Female | 24 (36%) | 31 (29%) | 35 (100%) | 90 (43%) |
| Age, y | Median (quartiles) | 38 (32–42) | 37 (31–44) | 31 (26–38) | 37 (30–42) |
| CD4 count, cells/µL | Median (quartiles) | 141 (46–248) | 107 (32–302) | 137 (80–178) | 118 (42–253) |
| HIV-1 RNA, log10 copies/mL | Median (quartiles) | 4.8 (4.4–5.2) | 4.8 (4.5–5.4) | 5.4 (4.8–5.8) | 4.8 (4.5–5.5) |
| First-line ART | LPV/r + 3TC + TDF | 20 (30%) | 0 (0%) | 0 (0%) | 20 (10%) |
| LPV/r + 3TC + ZDV | 28 (42%) | 0 (0%) | 0 (0%) | 28 (13%) | |
| LPV/r + 3TC + D4T | 19 (28%) | 0 (0%) | 0 (0%) | 19 (9%) | |
| LPV/r + TDF + FTC | 0 (0%) | 0 (0%) | 35 (100%) | 35 (17%) | |
| ATV/r + 3TC + ABC | 0 (0%) | 64 (60%) | 0 (0%) | 64 (31%) | |
| ATV/r + TDF + FTC | 0 (0%) | 43 (40%) | 0 (0%) | 43 (21%) | |
| Characteristics at first-line virologic failure | |||||
| Age, y | Median (quartiles) | 39 (34–43) | 39 (33–46) | 33 (28–39) | 38 (32–44) |
| Achieved HIV-1 RNA <400 copies/mL at any time prior to initial failure | Yes | 53 (79%) | 85 (79%) | 26 (74%) | 164 (78%) |
| Weeks from ART initiation | Median (quartiles) | 39 (14–76) | 37 (24–84) | 48 (13–72) | 39 (18–76) |
| HIV-1 RNA, log10 copies/mL | Median (quartiles) | 3.8 (3.2–4.7) | 3.8 (3.0–4.6) | 4.2 (3.3–5.0) | 3.9 (3.2–4.7) |
| CD4 count, cells/µL | Median (quartiles) | 251 (187–370) | 269 (156–425) | 180 (129–316) | 246 (160–404) |
| CD4 count change from ART initiation, cells/µL | Median (quartiles) | 95 (50–243) | 100 (39–182) | 74 (6–201) | 96 (35–190) |
| Self-reported adherence within 4 d Prior to clinic visit | Not on ART | 6 (9%) | 12 (11%) | 1 (3%) | 19 (9%) |
| <100% | 23 (34%) | 18 (17%) | 7 (20%) | 48 (23%) | |
| 100% | 33 (49%) | 70 (65%) | 27 (77%) | 130 (62%) | |
| Unknown | 5 (13%) | 7 (2%) | 0 | 12 (6%) | |
| Drug resistancea | Major PI-associatedb | 0 (0%) | 5 (5%) | 0 (0%) | 5 (3%) |
| Minor PI-associated | 43 (88%) | 96 (90%) | 32 (100%) | 171 (91%) | |
| NNRTI-associatedc | 1 (2%) | 3 (3%) | 3 (9%) | 7 (4%) | |
| NRTI- associatedd | 12 (24%) | 20 (19%) | 6 (19%) | 38 (20%) | |
| Not available | 18 | 0 | 3 | 21 | |
Data are presented as No. (%) unless otherwise specified.
Abbreviations: 3TC, lamivudine; ABC, abacavir; ART, antiretroviral therapy; ATV/r, ritonavir-boosted atazanavir; d4T, stavudine; FTC, emtricitabine; HIV-1, human immunodeficiency virus type 1; LPV/r, ritonavir-boosted lopinavir; NNRTI, nonnucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse-transcriptase inhibitor; PI, protease inhibitor; TDF, tenofovir; ZDV, zidovudine.
a Resistance mutations were defined as those listed by the International Antiviral Society (IAS)–USA for A5142 (2006 version) [12] and A5208 (2008 version) [13]; for A5202, they were defined as those listed by the IAS-USA 2008 version [13], as well as T69D, L74I, and G190C/E/Q/T/V for major reverse transcriptase–associated mutations, and L24I, F53L, I54V/A/T/S, G73C/S/T/A, and N88D for major protease-associated mutations.
b Only 1 of the 5 participants selected a major protease-associated resistance mutation (N88S) after treatment initiation; the other 4 participants had mutations (I54V, L90M, L33F, and G73A/L90M, respectively) prior to starting treatment.
c All 7 participants had NNRTI-associated resistance mutations before treatment initiation.
d Fifteen participants selected NRTI-associated resistance mutations after treatment initiation; the other 23 participants had mutations present prior to starting treatment. Among the 38 participants with NRTI-associated resistance mutations, 2 (5%) had K65R mutation, 20 (53%) had M184V mutation, and 3 (8%) had thymidine-associated mutations.