TABLE 5.
| Laboratory Test§ | Toxicity Criteria† |
Raltegravir Group N = 281, m/n (%) |
Efavirenz Group N = 282, m/n (%) |
|---|---|---|---|
| Absolute neutrophil count | <750 cells/µL | 7/281 (2.5) | 3/278 (1.1) |
| Hemoglobin | <7.5 gm/dL | 2/281 (0.7) | 2/278 (0.7) |
| Platelet count | <50,000/µL | 0/276 (0.0) | 1/276 (0.4) |
| Fasting total cholesterol | >300 mg/dL | 0/276 (0.0) | 11/267 (4.1) |
| Fasting LDL-cholesterol | ≥190 mg/dL | 3/271 (1.1) | 17/262 (6.5) |
| Fasting triglycerides | >750 mg/dL | 1/276 (0.4) | 4/267 (1.5) |
| Fasting glucose | >250 mg/dL | 3/274 (1.1) | 0/266 (0.0) |
| Total bilirubin | >2.5 × ULN | 2/281 (0.7) | 0/279 (0.0) |
| Alkaline phosphatase | >5 × ULN | 0/281 (0.0) | 2/279 (0.7) |
| Aspartate aminotransferase | >5 × ULN | 9/281 (3.2) | 8/279 (2.9) |
| Alanine aminotransferase | >5 × ULN | 5/281 (1.8) | 7/279 (2.5) |
Grades 3/4 by DAIDS criteria [http://rcc.tech-res-intl.com/tox_tables.htm].
All treated patients were included in the safety analysis. All laboratory abnormalities exceeding the predefined limit of change through May 6, 2009 (the day when the last patient remaining in the study had their 96-week assessment) were tallied. Only patients with a worsened grade from baseline were included.
Although there were no grade 3 or 4 abnormalities of serum creatinine levels (≥1.9 × ULN), the frequency of grade 1 elevations in serum creatinine concentration from baseline was 5.7% (16 of 281) in the raltegravir group compared with 1.1% (3 of 279) in the efavirenz group, and the frequency of grade 2 elevations was 0.4% (1 of 281) in the raltegravir group compared with 0.4% (1 of 279) in the efavirenz group. The mean change from baseline was 0.01 for raltegravir recipients and −0.03 for efavirenz recipients.
N, total number of treated patients in each group.
m, number of patients with Grade 3 or 4 abnormalities of the specified laboratory test.
n, number of patients with results for the specified laboratory test.
ULN, upper limit of normal range.