Table 2. Treatment-emergent adverse reactions and laboratory abnormalities of at least moderate intensity (grades 2 to 4) in treatment-naive patients enrolled in the SPRING-2 study 1.
| Dolutegravir + 2 NRTIs (n = 403) | Raltegravir + 2 NRTIs ( n = 405) | |
| Adverse reactions | ||
| Nausea | 1% | 1% |
| Abnormal dreams | < 1% | < 1% |
| Diarrhea | < 1% | < 1% |
| Dizziness | < 1% | < 1% |
| Headache | < 1% | < 1% |
| Insomnia | < 1% | < 1% |
| Rash | 0% | < 1% |
| Vertigo | 0% | < 1% |
| Laboratory abnormalities | ||
| ALT elevation | ||
| Grade 2 (>2.5 to 5 × ULN) | 2% | 3% |
| Grade 3 to 4 (> 5.1 × ULN) | 2% | 1% |
| AST elevation | ||
| Grade 2 (> 2.5 to 5 × ULN) | 3% | 3% |
| Grade 3 to 4 (> 5.1 × ULN) | 2% | 2% |
| Total bilirubin elevation | ||
| Grade 2 (1.6 to 2.5 × ULN) | 2% | 2% |
| Grade 3 to 4 (> 2.5 × ULN) | < 1% | < 1% |
| Creatine kinase elevation | ||
| Grade 2 (6 to 9.9 × ULN) | 1% | 3% |
| Grade 3 to 4 (> 10 × ULN) | 4% | 3% |
| Hyperglycemia | ||
| Grade 2 (126 to 250 mg/dL) | 5% | 5% |
| Grade 3 (> 251 mg/day) | < 1% | 1% |
| Lipase elevation | ||
| Grade 2 (> 1.5 to 3 × ULN) | 5% | 6% |
| Grade 3 to 4 (> 3.1 × ULN) | 1% | 3% |
| Total neutrophil reduction | ||
| Grade 2 (0.75 to 0.99 × 109) | 3% | 3% |
| Grade 3 to 4 (< 0.74 × 109) | 2% | 1% |
Note: ALT = alanine aminotransferase; AST = aspartate aminotransferase; NRTIs = nucleoside reverse transcriptase inhibitors; ULN = upper limit of normal.