Table 3.
Clinical outcomes (Incident AIDS-defining event, death, and composite measure of these 2 outcomes) within 2 years of ART initiation among 13,546 antiretroviral naïve HIV-infected patients in the Antiretroviral Therapy Cohort Collaboration (ART-CC) initiating ART with zidovudine and lamivudine stratified by 3rd drug, 2000 – 2005.
| Hazard ratio (95% CI) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 3rd Drug | Obs. | Incident AIDS event | Death | Incident AIDS event or Death | ||||||
| N | Crude | Adjusteda | N | Crude | Adjusteda | N | Crude | Adjusteda | ||
| EFV | 3,788 | 259 | 1 | 1 | 98 | 1 | 1 | 320 | 1 | 1 |
| NVP | 2,151 | 117 | 0.90 (0.72, 1.12) | 1.28 (1.02, 1.60) | 54 | 1.16 (0.82, 1.64) | 1.54 (1.09, 2.19) | 147 | 0.91 (0.74, 1.11) | 1.27 (1.04, 1.56) |
| LPV/r | 2,875 | 208 | 1.39 (1.15, 1.68) | 1.14 (0.93, 1.39) | 72 | 1.46 (1.06, 2.02) | 1.12 (0.80, 1.57) | 249 | 1.39 (1.16, 1.65) | 1.13 (0.94, 1.36) |
| NFV | 2,217 | 146 | 1.02 (0.83, 1.26) | 0.98 (0.79, 1.21) | 47 | 0.88 (0.62, 1.25) | 0.89 (0.63, 1.28) | 167 | 0.95 (0.79, 1.15) | 0.92 (0.76, 1.11) |
| ABC | 2,515 | 130 | 0.85 (0.69, 1.06) | 1.12 (0.89, 1.40) | 62 | 1.21 (0.87, 1.68) | 1.41 (1.01, 1.99) | 175 | 0.95 (0.79, 1.15) | 1.22 (1.00, 1.48) |
| Table 3a. Sensitivity analysis restricted to 6,235 patients with baseline CD4 counts ≤200 cells/μL at ART initiation. | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Hazard ratio (95% CI) | ||||||||||
| 3rd Drug | Obs. | Incident AIDS event | Death | Incident AIDS event or Death | ||||||
| N | Crude | Adjusted | N | Crude | Adjusted | N | Crude | Adjusted | ||
| EFV | 1,837 | 206 | 1 | 1 | 69 | 1 | 1 | 244 | 1 | 1 |
| NVP | 697 | 66 | 0.96 (0.73, 1.28) | 1.13 (0.85, 1.50) | 37 | 1.70 (1.12, 2.58) | 1.99 (1.31, 3.03) | 86 | 1.05 (0.82, 1.36) | 1.24 (0.96, 1.59) |
| LPV/r | 1,771 | 178 | 1.13 (0.91, 1.39) | 1.08 (0.86, 1.36) | 57 | 1.23 (0.85, 1.79) | 1.02 (0.69, 1.51) | 207 | 1.13 (0.93, 1.38) | 1.06 (0.86, 1.30) |
| NFV | 1,059 | 118 | 1.03 (0.81, 1.29) | 0.94 (0.74, 1.19) | 28 | 0.73 (0.47, 1.15) | 0.72 (0.46, 1.14) | 133 | 0.98 (0.79, 1.22) | 0.91 (0.73, 1.14) |
| ABC | 871 | 87 | 1.03 (0.79, 1.33) | 1.14 (0.87, 1.49) | 40 | 1.59 (1.06, 2.39) | 1.63 (1.07, 2.47) | 115 | 1.18 (0.94, 1.49) | 1.29 (1.01, 1.63) |
| Table 3b. Sensitivity analysis restricted to 11,806 patients with mode of HIV acquisition recorded as non-IDU. | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Hazard ratio (95% CI) | ||||||||||
| 3rd Drug | Obs. | Incident AIDS event | Death | Incident AIDS event or Death | ||||||
| N | Crude | Adjusteda | N | Crude | Adjusteda | N | Crude | Adjusteda | ||
| EFV | 3,247 | 224 | 1 | 1 | 74 | 1 | 1 | 270 | 1 | 1 |
| NVP | 1,807 | 94 | 0.84 (0.65, 1.07) | 1.18 (0.92, 1.52) | 41 | 1.13 (0.76, 1.67) | 1.55 (1.04, 2.33) | 117 | 0.86 (0.68, 1.07) | 1.20 (0.95, 1.50) |
| LPV/r | 2,211 | 188 | 1.36 (1.11, 1.66) | 1.09 (0.88, 1.35) | 62 | 1.57 (1.10, 2.25) | 1.14 (0.78, 1.66) | 221 | 1.36 (1.13, 1.64) | 1.08 (0.89, 1.32) |
| NFV | 1,754 | 129 | 1.09 (0.87, 1.36) | 1.02 (0.81, 1.28) | 32 | 0.83 (0.55, 1.27) | 0.88 (0.57, 1.34) | 142 | 1.00 (0.81, 1.23) | 0.95 (0.77, 1.18) |
| ABC | 1,870 | 96 | 0.77 (0.60, 0.98) | 0.99 (0.77, 1.28) | 45 | 1.24 (0.85, 1.82) | 1.62 (1.09, 2.42) | 130 | 0.89 (0.72, 1.11) | 1.16 (0.92, 1.45) |
| Table 3c. Longer-term clinical outcomes removing the 2 year censoring with follow-up through 1 July 2006 or cohort specific database close date. | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Hazard ratio (95% CI) | ||||||||||
| 3rd Drug | Obs. | Incident AIDS event | Death | Incident AIDS event or Death | ||||||
| N | Crude | Adjusteda | N | Crude | Adjusteda | N | Crude | Adjusteda | ||
| EFV | 3,788 | 312 | 1 | 1 | 152 | 1 | 1 | 399 | 1 | 1 |
| NVP | 2,151 | 143 | 0.91 (0.74, 1.12) | 1.24 (1.01, 1.52) | 74 | 1.02 (0.77, 1.36) | 1.29 (0.96, 1.72) | 185 | 0.92 (0.77, 1.10) | 1.22 (1.02, 1.47) |
| LPV/r | 2,875 | 223 | 1.43 (1.20, 1.72) | 1.18 (0.97, 1.43) | 85 | 1.39 (1.05, 1.85) | 1.06 (0.79, 1.43) | 268 | 1.40 (1.19, 1.64) | 1.15 (0.97, 1.37) |
| NFV | 2,217 | 193 | 1.10 (0.92, 1.32) | 1.05 (0.87, 1.26) | 83 | 0.95 (0.73, 1.25) | 0.93 (0.70, 1.22) | 231 | 1.03 (0.87, 1.21) | 0.98 (0.83, 1.16) |
| ABC | 2,515 | 155 | 0.87 (0.72, 1.07) | 1.11 (0.91, 1.37) | 86 | 1.14 (0.87, 1.50) | 1.32 (1.00, 1.75) | 214 | 0.97 (0.82, 1.16) | 1.21 (1.02, 1.45) |
EFV, efavirenz; NVP, nevirapine; LPV/r, lopinavir/ritonavir; NFV, nelfinavir; ABC, abacavir
a
Multivariable Weibull regression models adjusted for age, sex, IDU, entry CD4, entry HIV RNA, and year starting ART and stratified on cohort. Follow up restricted to 2 years.