Table 3. Change from Baseline at Week 12 in Fasting Lipids (Modified Intent To Treat Analysis Set.
Immediate Switch | Delayed Switch | ||||
---|---|---|---|---|---|
Change From Baseline 12 Weeks post-switch | EFV/FTC/TDF (N = 79) | ABC/3TC+EFV(N = 74) | Delayed Switch to EFV/FTC/TDF a (N = 73) | p-value b | Diff in LSM (95% CI) c |
Fasting Total Cholesterol (mmol/L) | |||||
N | 79 | 73 | 68 | <.001 | −0.74 (−1.00, −0.47) |
Median | −0.86 | 0.01 | −0.73 | ||
p-value d | <.001 | 0.45 | <.001 | ||
LDL Cholesterol (mmol/L) | |||||
N | 79 | 73 | 68 | <.001 | −0.47 (−0.70, −0.25) |
Median | −0.57 | 0.00 | −0.61 | ||
p-value d | <.001 | 0.47 | <.001 | ||
HDL Cholesterol (mmol/L) | |||||
N | 78 | 73 | 68 | <.001 | −0.15 (−0.21, −0.08) |
Median | −0.13 | 0.04 | −0.14 | ||
p-value d | <.001 | 0.44 | <.001 | ||
Triglycerides (mmol/L) | |||||
N | 79 | 73 | 68 | <.001 | −0.43 (−0.75, −0.11) |
Median | −0.26 | 0.02 | −0.13 | ||
p-value d | <.001 | 1.00 | 0.063 |
aDelayed Switch to EFV/FTC/TDF column includes subjects who were randomized to continue ABC/3TC+EFV at baseline and had at least 1 dose of EVF/FCT/TDF after switch at Week 12.
bThe p-value for comparison between EFV/FTC/TDF and ABC/3TC +EFV at study Week 12 is from Wilcoxon rank sum test.
cThe 95% confidence interval for the difference (EFV/FTC/TDF vs. ABC/3TC+EFV) is based on normal approximation.
dThe p-value for within treatment group comparison is from Wilcoxon signed rank test.