|
se inhibitors were lopinavir, amprenavir, saquinavir or indinavir and 85.1% of patients were possibly resistant or resistant to the chosen protease inhibitors. |
|
a Patients achieved and maintained a confirmed ≥1 log10 HIV-1 RNA drop from baseline through Week 48 without prior evidence of treatment failure. |
|
b Patients did not achieve a 0.5 log10 HIV-1 RNA drop from baseline and did not have viral load <100,000 copies/mL by Week 8. |
|
c Death only counted if it was the reason for treatment failure. |
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d Includes patients who were lost to-follow-up, withdrawn consent, non-adherent, protocol violations, added/changed background antiretroviral drugs for reasons other than tolerability or toxicity, or discontinued while suppressed. |
|
Virologic Respondersa (confirmed at least 1 log10 HIV-1 RNA below baseline) |
33.8% |
14.9% |
Virologic failures
Initial lack of virologic
response by Week 8b
Rebound
Never suppressed |
55.1%
33.0%
18.9%
3.2% |
77.3%
57.9%
16.4%
3.0% |
Deathc or discontinued due to adverse events
Death
Discontinued due to adverse events |
5.9%
0.5%
5.4% |
1.9%
0.3%
1.6% |
|
Discontinued due to other reasonsd |
5.2% |
5.8% |
Through 48 weeks of treatment, the proportion of patients in the APTIVUS/ritonavir arm compared to the comparator PI/ritonavir arm with HIV-1 RNA <400 copies/mL was 30.3% and 13.6% respectively, and with HIV-1 RNA <50 copies/mL was 22.7% and 10.2% respectively. Among all randomized and treated patients, the median change from baseline in HIV-1 RNA at the last measurement up to Week 48 was -0.64 log10 copies/mL in patients receiving APTIVUS/ritonavir versus -0.22 log10 copies/mL in the comparator PI/ritonavir arm.
Among all randomized and treated patients, the median change from baseline in CD4+ cell count at the last measurement up to Week 48 was +23 cells/mm3 in patients receiving APTIVUS/ritonavir (N=740) versus +4 cells/mm3 in the comparator PI/ritonavir (N=727) arm.
Patients in the APTIVUS/ritonavir arm achieved a significantly better virologic outcome when APTIVUS/ritonavir was combined with enfuvirtide. Among patients with new enfuvirtide use, the proportion of patients in the APTIVUS/ritonavir arm compared to the comparator PI/ritonavir arm with HIV-1 RNA <400 copies/mL was 52.4% and 19.6% respectively, and with HIV-1 RNA <50 copies/mL was 37.3% and 14.4% respectively [see Clinical Pharmacology (12.2, 12.4)]. The me
