Table 3.
Estimated probabilities (95% confidence interval) of virologic outcome
Outcome* | ||||
---|---|---|---|---|
LPV/r BID | LPV/r QD | Difference | ||
SVR† (Intent-to-treat) | Overall | 0.81 ( 0.73, 0.86) | 0.78 (0.70, 0.84) | 0.03 (−0.07, 0.12) |
<100,000 cp/mL | 0.72 ( 0.59, 0.81) | 0.80 ( 0.69, 0.88) | −0.09 (−0.23, 0.06) | |
≥100,000 cp/mL | 0.89 ( 0.79, 0.94) | 0.76 ( 0.64, 0.84) | 0.13 (0.01, 0.25) | |
SVR† (As-treated) | Overall | 0.85 ( 0.78, 0.90) | 0.85 ( 0.78, 0.90) | 0 (−0.09, 0.09) |
<100,000 cp/mL | 0.80 ( 0.67, 0.88) | 0.86 ( 0.75, 0.93) | −0.07 (−0.20, 0.07) | |
≥100,000 cp/mL | 0.90 ( 0.80, 0.95) | 0.84 ( 0.73, 0.91) | 0.06 (−0.06, 0.17) | |
Regimen completion‡ | Overall | 0.66 ( 0.58, 0.73) | 0.61 ( 0.53, 0.68) | 0.05 (−0.05, 0.16) |
<100,000 cp/mL | 0.58 ( 0.47, 0.69) | 0.61 ( 0.49, 0.71) | −0.02 (−0.18, 0.13) | |
≥100,000 cp/mL | 0.73 ( 0.62, 0.81) | 0.61 ( 0.50, 0.71) | 0.12 (−0.02, 0.26) | |
HIV-1 RNA <200 cp/mL | Overall | 0.87 ( 0.81, 0.93) | 0.81 ( 0.74, 0.88) | 0.06 (−0.03, 0.15) |
<100,000 cp/mL | 0.82 ( 0.72, 0.91) | 0.80 ( 0.70, 0.90) | 0.02 (−0.12, 0.15) | |
≥100,000 cp/mL | 0.91 ( 0.84, 0.98) | 0.82 ( 0.73, 0.91) | 0.09 (−0.02, 0.20) |
Based on Kaplan-Meier estimates and of having an HIV-1 RNA result <200 copies/mL at week 48 based on a cross-sectional analysis (missing data excluded), and corresponding differences with 95% CI overall and by screening HIV-1 RNA level
Sustained virologic response (SVR) defined as remaining free of virologic failure. Virologic failure = any one of the following three occurrences: confirmed HIV-1 RNA ≥200 cp/mL after two consecutive HIV-1 RNA <200 cp/mL (confirmed relapse); confirmed HIV-1 RNA ≥200 cp/mL at or after visit week 24 without prior viral relapse; HIV-1 RNA ≥200 cp/mL at visit week 48, which did not require confirmation
Regimen completion = virologic failure or discontinuation of initially randomized LPV/r dose schedule, whichever occurred earlier