Table 3.
BENCHMRK-1 and 2: treatment outcome at week 16
| BENCHMRK-1 |
BENCHMRK-2 |
|||
|---|---|---|---|---|
| Raltegravir | Placebo | Raltegravir | Placebo | |
| n | 232 | 118 | 230 | 119 |
| Proportion of patients with HIV-1 RNA <400 copies/mL | 76.7% | 40.7% | 77% | 42.9% |
| Proportion of patients with HIV-1 RNA <50 copies/mL | 60.8% | 33.1% | 61.7% | 36.1% |
| Proportion of patients with >1 log decline in HIV-1 RNA | 84.9% | 41.5% | 82.6% | 50.4% |
| Mean change in HIV-1 RNA (log10 copies/mL) from baseline | −1.85 | −0.78 | −1.92 | −1.06 |
| Mean change in CD4 count (cells/mm3) from baseline | +82.7 | +31.3 | +85.1 | +39.7 |
| Virologic failure – non respondera | 1.7% | 37.3% | 3.9% | 28.6% |
| Virologic failure – reboundb | 12.1% | 16.1% | 12.6% | 19.3% |
Derived from Isentress FDA Briefing Document 2007.
a
non-responders did not achieve >1.0 log10 HIV RNA reduction or <400 HIV RNA copies/mL by week 16.
b
viral rebound was defined as: (a) HIV RNA >400 copies/mL (on 2 consecutive measurements at least 1 week apart) after initial response with HIV RNA >400 copies/mL, or (b) >1.0 log10 increase in HIV RNA above nadir level (on 2 consecutive measurements at least 1 week apart).