Table 2. Treatment assignment and differences in fold-change urine protein:creatinine and albumin:creatinine ratios.
| NRTI effect | Urine protein:creatinine ratio, mg/g
|
Urine albumin:creatinine ratio, mg/g
|
||
|---|---|---|---|---|
| n | Δ, ABC/3TC versus TDF/FTC | n | Δ, ABC/3TC versus TDF/FTC | |
| Intention-to-treat, Week 0 to 96 | 167 | -21.7% (95% CI -35.1%, -5.5%); p=0.011 | 178 | -28.8% (95% CI -46.2%, -5.8%); p=0.018 |
| As-treated, Week 0 to 96 | 140 | -20.7% (95% CI -35.4%, -2.6%); p=0.027 | 149 | -24.8% (95% CI -44.1%, 1.2%); p=0.060 |
| Stratified analysis, Week 0 to 96 | ||||
| ATV/r arm | 79 | -28.9% (95% CI -45.8%, -6.6%) | 88 | -27.7% (95% CI -51.6%, 8.1%) |
| EFV arm | 88 | -14.4% (95% CI -33.9%, 10.8%) | 90 | -29.9% (95% CI -52.9%, 4.1%) |
| Sensitivity analysis, Week 0 to 96 | ||||
| HIV-RNA<50copies/mL* | 144 | - 18.1% (95% CI -33.4%, 0.7%); p=0.058 | 154 | -26.5% (-46.0%, -0.1%); p=0.049 |
| Intention to treat, Week 0 to 48 | 191 | -16.5% (95% CI -29.9%, -0.6%); p=0.043 | 194 | -4.4% (95% CI -27.3%, 25.6%); p=0.74 |
| NNRTI/PI effect | n | Δ, ATV/r versusEFV | n | Δ, ATV/r versusEFV |
| Intention-to-treat, Week 0 to 96 | 167 | -11.0% (95% CI -26.5%, 7.7%); p=0.23 | 178 | -2.2% (95% CI -26.4%, 30.0%); p=0.88 |
| As-treated, Week 0 to 96 | 143 | -9.8 (95% CI -26.7%, 10.9%); p=0.32 | 154 | -11.6% (95% CI -34.5%, 19.4%); p=0.42 |
| Stratified analysis, Week 0 to 96 | ||||
| TDF/FTC | 83 | -2.2% (95% CI -25.1%, 27.7%) | 86 | -2.7% (95% CI -35.2%, 46.0%) |
| ABC/3TC | 84 | -18.7% (95% CI-37.6%, 6.0%) | 92 | 0.5% (95% CI -32.1%, 48.7%) |
| Sensitivity analysis, Week 0 to 96 | ||||
| HIV-RNA<50copies/mL* | 144 | -6.4% (-24.0%, 15.4%); p=0.54 | 154 | 0.8% (-26.2%, 37.6%); p=0.96 |
| Intention to treat, Week 0 to 48 | 191 | -11.1% (-25.5%, 5.9%); p=0.19 | 194 | -7.6% (-29.6%, 21.5%); p=0.57 |
ABC/3TC, abacavir/lamivudine; TDF/FTC, tenofovir disoproxil fumarate/emtricitabine; ATV/r, atazanavir/ritonavir; EFV, efavirenz. In the as-treated analysis, participants were censored after a change in the assigned NRTI (for the analysis of NRTI effect) or NNRTI/PI (for the analysis of NNRTI/PI effect). Because of the limited sample size within strata, the results of the stratified analyses are provided for descriptive purposes only.
*
Analyses in this table were planned a priori, with the exception of the sensitivity analyses including only participants who achieved HIV-RNA < 50 copies/mL at week 96.