Table 3.
Adverse events and discontinuation rates within clinical trials comparing 2DRs and 3DRs.
| Clinical Trial | 2DR Arm | Comparator | Total Number of Patients with One or More AEs | Total Number of Patients with One or More SAEs | Discontinuation Because of Adverse Events or Death | eGFR Difference in mL/min/1.7 m2 |
|---|---|---|---|---|---|---|
| GARDEL | LPV/r + 3TC | LPV/r + 2 NRTIs | 65 (30%) vs. 88 (44%) † | 1 (<1%) vs. 0 ‡ | 3 (1%) vs. 16 (8%) | Not reported |
| OLE | LPV/r + 3TC | LPV/r + 2 NRTIs | 63 (53%) vs. 70 (58%) | 5 (4%) vs. 8 (7%) | 1 (1%) vs. 4 (3%) | Not reported |
| SALT | ATV/r + 3TC | ATV/r + 2 NRTIs | 99 (70.7%) vs. 99 (70.2%) | 10 (7.5%) vs. 9 (6.7%) | 7 (5.3%) vs. 11 (8.2%) | −0.8 vs. −1.4 |
| ATLAS-M | ATV/r + 3TC | ATV/r + 2 NRTIs | 33 (24.8%) vs. 40 (30.1% | 3 (2.3%) vs. 4 (3.0%) | 4 (3.0%) vs. 8 (6%) | +2 vs. −5 |
| DUAL-GESIDA 8014 | DRV/r + 3TC | DRV/r + 2 NRTIs | 88 (70%) vs. 93 (76%) | 6 (5%) vs. 6 (5%) | 1 (1%) vs. 2 (2%) | Not reported |
| SECOND LINE | LPV/r + RAL | LPV/r + 2 or 3 NRTIs | 993 vs. 895 * | 23 (8.5%) vs. 24 (8.9%) | 11 (4%) vs. 8 (3%) | −5.2 vs. −4.7 |
| SELECT | LPV/r + RAL | LPV/r + 2 or 3 NRTIs | 18 (7%) vs. 27 (11%) | 5 (1.9%) vs. 5 (1.9%) | 3 (1.2%) vs. 3 (1.2%) | Not reported |
| EARNEST | LPV/r + RAL | LPV/r + 2 or 3 NRTIs | 104 (24%) vs. 92 (23%) | 93 (22%) vs. 91 (21%) | 30 (6.9%) vs. 30 (7.0%) ¶ | −5.4 vs. −11.2 |
| GEMINI 1 and 2 | DTG + 3TC | DTG + FTC/TDF | 543 (76%) vs. 579 (81%) | 50 (7%) vs. 55 (85) | 10 (1%) vs. 13 (2%) | −2.1 vs. −15.5 |
| TANGO | DTG + 3TC | TAF-based 3DR | 295 (79.9%) vs. 292 (78.7%) | 21 (5.7%) vs. 16 (4.3%) | 13 (3.5%) vs. 2 (0.5%) | −7.7 vs. −3.0 |
| SWORD 1 and 2 | DTG + RPV | 3DR | 395 (77%) vs. 364 (71%) | 27 (5%) vs. 21 (4%) | 17 (3%) vs. 3 (1%) | Not reported |
| DUALIS | DTG + bDRV | DRV-based 3DR | 104 (78.2%) vs. 100 (75.2%) | 7 (5.3%) vs. 7 (5.3%) | 14 (4.6%) vs. 5 (1.6%) | Not reported |
| NEAT001/ANRS 143 | DRV/r + RAL | DRV/r + FTC/TDF | 34 vs. 38 ** | 73 (18.2%) vs. 61 (15.1%) | 1.5% vs. 2.6% | +0.8 vs. −4.6 |
| PROBE-2 | bDRV + RPV | 3DR | 6 (7.5%) vs. 3 (3.4%) | Not reported | 6 vs. 0 | Not reported |
| FLAIR | CAB + RPV | DTG/3TC/ABC | 267 (94%) vs. 225 (80%) | 18 (6%) vs. 12 (4%) | 9 (3%) vs. 4 (1%) | Not reported |
† Grade 2–3 AEs; ‡ Only drug-related SAEs; * Total number of AEs; ¶ Only discontinuations due to death; ** Only number of AEs leading to treatment modification.