Table 2.
Selected Events That Triggered a Safety Endpoint While Receiving Randomized Antiretroviral Drugs in Low Screening HIV RNA Stratum
| ABC (n = 263) | TDF (n = 265) | ABC (n = 264) | TDF (n = 263) | All subjects (n = 1055)a | |
| ATV/r | EFV | ||||
| Overall, n (%) | 80 (30) | 78 (29) | 98 (37) | 83 (32) | 339 (32) |
| Metabolic, n (%) | 22 (8) | 19 (7) | 24 (9) | 13 (5) | 78 (7) |
| Total cholesterol (fasting), n | 4 | 1 | 9 | 4 | … |
| LDL (fasting), n | 7 | 7 | 15 | 8 | … |
| Triglycerides (fasting), n | 8 | 3 | 5 | 0 | … |
| Glucose (nonfasting) | 2 | 5 | 0 | 1 | … |
| Gastrointestinal, n (%) | 21 (8) | 16 (6) | 12 (5) | 12 (5) | 61 (6) |
| Diarrhea/loose stool, n | 2 | 4 | 8 | 2 | … |
| ALT, n | 7 | 1 | 1 | 6 | … |
| Nausea and/or vomiting, n | 6 | 3 | 3 | 1 | … |
| Neuropsychological, n (%) | 8 (3) | 1 (<1) | 16 (6) | 14 (5) | 39 (4) |
| Depression, n | 3 | 0 | 3 | 7 | … |
| General body, n (%) | 29 (11) | 30 (11) | 42 (16) | 30 (11) | 131 (12) |
| Ache/pain/discomfort, n | 20 | 11 | 12 | 17 | … |
| Fever, n | 6 | 7 | 6 | 1 | … |
| Asthenia/fatigue, n | 3 | 3 | 7 | 3 | … |
| Rash/allergic reaction, n | 2 | 2 | 5 | 2 | … |
| Headache, n | 3 | 3 | 6 | 1 | … |
| Hematologic, n (%) | 1 (<1) | 7 (3) | 4 (2) | 7 (3) | 19 (2) |
| Neutrophil count, n | 1 | 6 | 4 | 7 | … |
Events are listed if >2% of patients had an event in a major category with frequency selected if ≥5 in any study arm.
Abbreviations: ABC indicates abacavir; TDF, tenofovir DF; ATV/r, atazanavir/ritonavir; EFV, efavirenz; LDL, low-density lipoprotein; ALT, alanine aminotransferase.
a
Includes patients who started study medication.