Table 1. Baseline Demographics, Clinical Characteristics, and Antiretroviral Treatment History as Predictors of Virologic Response to Saquinavir–Ritonavir Therapy.
| Characteristic | Overall | Complete Response* | Partial Response† | Nonresponse‡ | P Value§ |
|---|---|---|---|---|---|
| Demographic characteristic | |||||
| Patients, n (%) | 54 | 22 (41) | 14 (26) | 18 (33) | |
| Median age, y | 41 | 39 | 42.5 | 38.5 | >0.2 |
| Men, n (%) | 51 (94) | 20 (90) | 13 (93) | 18 (100) | >0.2 |
| White, non-Hispanic ethnicity, n (%) | 39 (72) | 14 (64) | 12 (86) | 13 (72) | >0.2 |
| Baseline clinical characteristics | |||||
| AIDS diagnosis, n (%)‖ | 20 (37) | 5 (23) | 5 (36) | 10 (56) | 0.03 |
| Median CD4 count (range), ×109/L | 245 (5–1060) | 295 (20–1060) | 220 (5–460) | 155 (9–470) | <0.01 |
| Median log10 plasma HIV-1 RNA level (range), copies/mL | 5.0 (3–5.9) | 4.0 (3.0 –5.9) | 5.0 (4.1–5.9) | 5.0 (4.0 –5.9) | <0.01 |
| Antiretroviral treatment history | |||||
| Median nucleoside reverse transcriptase inhibitors (range), n | 4 (2–5) | 3 (2–5) | 4 (3–5) | 4 (2–5) | 0.01 |
| Median duration of prior nucleoside reverse transcriptase inhibitor therapy (range), wk | 188 (30–472) | 118 (30–346) | 226 (64–408) | 334 (75–472) | <0.01 |
| Patients with previous non-nucleoside reverse transcriptase inhibitor therapy, n (%) | 16 (29) | 8 (36) | 5 (36) | 3 (17) | 0.19 |
| Median previous protease inhibitors (range), n | 2 (1–4) | 1 (1–3) | 2 (1–3) | 2 (1– 4) | 0.01 |
| Median duration of protease inhibitor thearapy (range), wk | 48 (12–216) | 38 (12–104) | 48 (32–216) | 58 (24–156) | 0.08 |
| Patients who received new nucleoside reverse transcriptase inhibitors, n (%) | 13 (24) | 7 (32) | 3 (16) | 3 (17) | >0.2 |
| Previous protease inhibitors, n | |||||
| Indinavir | 14 | 5 | 4 | 5 | –¶ |
| Nelfinavir | 5 | 5 | 0 | 0 | – |
| Saquinavir then indinavir | 14 | 4 | 4 | 6 | – |
| Saquinavir then nelfinavir | 9 | 6 | 2 | 1 | – |
| Indinavir then nelfinavir | 1 | 1 | – | ||
| Ritonavir then indinavir | 2 | 0 | 1 | 1 | – |
| Saquinavir, nelfinavir, and indinavir | 7 | 1 | 2 | 4 | – |
| Saquinavir, ritonavir, and indinavir | 1 | 0 | 1 | 0 | – |
| All four protease inhibitors | 1 | 0 | 0 | 1 | – |
*
Defined as ≤500 copies/mL at 4 or 12 weeks.
†
Defined as a >0.5 log10 or greater reduction in plasma HIV-1 RNA level but not <500 copies/mL at 4 or 12 weeks.
‡
<0.5 log10 reduction at 4 or 12 weeks.
§
Linear regression.
‖
Excludes CD4 cell count criterion.
¶
No statistical test as a bivariate predictor.