Table 3.
Treatment-Limiting Adverse Events and New Grade 3 or 4 Clinical Events or Laboratory Abnormalities.*
| Event | Efavirenz Group (N = 250) | Lopinavir–Ritonavir Group (N = 253) | NRTI-Sparing Group (N = 250) |
|---|---|---|---|
| number (percent) | |||
| Treatment-limiting event | |||
| Pain or discomfort | 10 (4) | 5 (2) | 3 (1) |
| Fasting triglycerides† | 0 | 4 (2) | 11 (4) |
| Macules, papules, or rash‡ | 6 (2) | 0 | 3 (1) |
| Nausea | 3 (1) | 7 (3) | 3 (1) |
| Grade 3 or 4 clinical event | |||
| Any new sign or symptom | 42 (17) | 46 (18) | 43 (17) |
| Pain or discomfort | 14 (6) | 14 (6) | 19 (8) |
| Diarrhea or loose stool‡ | 1 (<1) | 8 (3) | 7 (3) |
| Nausea | 7 (3) | 4 (2) | 8 (3) |
| Macules, papules, or rash | 6 (2) | 2 (1) | 7 (3) |
| Headache | 6 (2) | 9 (4) | 2 (1) |
| Grade 3 or 4 laboratory abnormality | |||
| Any abnormality†§ | 72 (29) | 80 (32) | 107 (43) |
| Creatine kinase >5 times ULN | 8 (3) | 8 (3) | 14 (6) |
| Absolute neutrophil count <750/mm3 | 11 (4) | 18 (7) | 12 (5) |
| Fasting LDL cholesterol >190 mg/dl§ | 7 (3) | 2 (1) | 14 (6) |
| Fasting triglycerides >750 mg/dl†‡§ | 6 (2) | 16 (6) | 34 (14) |
| Hepatic aminotransferase >5 times ULN†¶ | 10 (4) | 16 (6) | 21 (8) |
| Lipase >2 times ULN‡ | 22 (9) | 11 (4) | 12 (5) |
| Clinical lipoatrophy†|| | 8 (3) | 3 (1) | 0 |
Treatment-limiting events, as determined by the site investigator, were defined as those occurring in 2% or more of patients in any study group. Adverse events are those that occurred in 3% or more of patients in any study group. To convert the values for cholesterol to millimoles per liter, multiply by 0.02586. To convert the values for triglycerides to milli-moles per liter, multiply by 0.01129. LDL denotes low-density lipoprotein, and ULN upper limit of the normal range.
P<0.05 for the pairwise comparison between the efavirenz group and the NRTI-sparing group, with no adjustment for multiple testing.
P<0.05 for the pairwise comparison between the efavirenz group and the lopinavir–ritonavir group, with no adjustment for multiple testing.
P<0.05 for the pairwise comparison between the lopinavir–ritonavir group and the NRTI-sparing group, with no adjustment for multiple testing.
Included in this category were aspartate aminotransferase, alanine aminotransferase, or both.
Included in this category were events of any grade reported by site investigators.