Table 2.
Efficacy and Safety Outcomes by Sex and Treatment Arm
| Outcome | Assigned treatment groupɣ |
Female N (%) |
Male N (%) |
Hazard Ratio (95% CI)* comparing females to males |
P Value† |
Adjusted Hazard Ratio (95% CI) |
|
|---|---|---|---|---|---|---|---|
| Efficacy Endpoints | |||||||
| Treatment failure | Overall | 142 (19.2) | 169 (20.3) | 0.018 | |||
| ZDV/3TC + EFV | 49 (20.3) | 49 (17.6) | 1.14 (0.76, 1.72) | 1.13 (0.75, 1.71)‡ | |||
| ATV + FTC + DDI-EC | 45 (17.6) | 73 (27.0) | 0.60 (0.41, 0.87) | 0.59 (0.40, 0.87)‡ | |||
| EFV + TDF/FTC | 48 (19.8) | 47 (16.5) | 1.21 (0.80, 1.83) | 1.25 (0.82, 1.92)‡ | |||
| Virologic failure | Overall | 113 (15.2) | 137 (16.5) | 0.013 | |||
| ZDV/3TC +EFV | 39 (16.2) | 39 (14.0) | 1.18 (0.75, 1.86) | 1.10 (0.69, 1.74)§ | |||
| ATV + FTC + DDI-EC | 34 (13.2) | 60 (22.2) | 0.57 (0.37, 0.88) | 0.56 (0.36, 0.86)§ | |||
| EFV + TDF/FTC | 40 (16.5) | 38 (13.3) | 1.33 (0.84, 2.11) | 1.38 (0.86, 2.21)§ | |||
| Disease progression | Overall | 19 (2.6) | 27 (3.2) | 0.78 (0.42, 1.47) | 0.45 | 0.84 (0.44, 1.58)‖ | |
| Death | Overall | 22 (3.0) | 34 (4.1) | 0.59 (0.34, 1.04) | 0.600 | 0.85 (0.47, 1.54)¶ | |
| Safety Endpoints | |||||||
| Primary safety | Overall | 393 (53.4) | 444 (53.6) | 0.002 | |||
| EFV + ZDV/3TC | 160 (66.4) | 153 (55.2) | 1.4 (1.1, 1.8) | 1.49 (1.18, 1.88)*** | |||
| ATV + FTC + DDI-EC | 126 (49.6) | 155 (57.8) | 0.82 (0.64, 1.04) | 0.82 (0.64, 1.05)*** | |||
| EFV + TDF/FTC | 107(44.4) | 136 (47.9) | 0.88 (0.68, 1.14) | 0.91, (0.70, 1.19)*** | |||
| Sign/symptom | Overall | 147 (20.0) | 184 (22.2) | 0.95 (0.75, 1.19) | 0.50 | 1.05 (0.82, 1.35) | |
| ****Abnormal laboratory | Overall | 164 (22.3) | 181 (21.8) | 0.84 (0.67, 1.06) | 0.090 | ||
| ZDV/3TC + EFV | 56 (23.2) | 61 (22.0) | 1.28 (0.89, 1.83) | ||||
| ATV + FTC + DDI-EC | 56 (22.0) | 60 (22.4) | 0.90 (0.61, 1.33) | ||||
| EFV + TDF/FTC | 35 (14.5) | 54 (19.0) | 0.66 (0.43, 1.04) | ||||
| Initial regimen change | Overall | 249 (33.8) | 299 (36.1) | 1.03 (0.86, 1.24) | 0.060 | ||
| ZDV/3TC+EFV | 109 (45.2) | 113 (40.8) | 1.35 (1.03, 1.79) | ||||
| ATV + FTC + DDI-EC | 79 (31.1) | 107 (39.9) | 0.84 (0.62, 1.14) | ||||
| EFV + TDF/FTC | 61 (25.3) | 79 (27.8) | 0.96 (0.68, 1.35) | ||||
Basic model adjusted for country and plasma HIV-1 RNA stratification factors, and treatment arm.
P value for interaction term between sex and treatment arm.
Adjusted model included age, race, pretreatment CD4+ lymphocytes and body measurements.
Adjusted model included age, race and pretreatment CD4+ lymphocytes.
Adjusted model included pretreatment CD4+ lymphocytes and body measurements.
Adjusted model race, pretreatment CD4+ lymphocytes, body measurements, prior AIDS diagnosis and serum ALT.
Adjusted model included serum AST, body measurements, and ethnicity
Adjusted model included baseline weight, body measurement, and serum AST
Antiretroviral drugs were: Efavirenz (EFV), lamivudine (3TC), zidovudine (ZDV), atazanavir (ATV), emtricitabine (FTC) and tenofovir-DF (TDF).