Table 1.
Study (Source) | Treatment Arms | N | Male | Age, y | Baseline mean CD4+, cells/mL (SD) | Baseline mean viral load, log10 RNA copies/mL, (SD) | N with Virologic Suppression HIV RNA < 50 copies/mL (r/n) | CD4+ change, cells/μL | AEs (r/n) | Drug-related AEs (r/n) | Serious AEs (r/n) | Discontin-uations (r/n) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ACTG A5257 ([15]) | ATV/r + TDF/FTC | 605 | 76.20 | 37 | 309 | 4.60a | 379/605 | 280 | 489/605 | – | – | 89/605 |
DRV/r + TDF/FTC | 601 | 76.21 | 37 | 310 | 4.61a | 437/601 | 256 | 390/601 | – | – | 101/601 | |
RAL + TDF/FTC | 603 | 75.46 | 36 | 304 | 4.66a | 481/603 | 288 | 359/603 | – | – | 72/603 | |
ECHO + THRIVE [16] | EFV + TDF/FTC | 546 | 78.94 | 36 | 261a | 5.0a | 422/546 | 222 | – | – | 61/546 | – |
RPV + TDF/FTC | 550 | 78.00 | 36 | 247a | 5.0a | 423/550 | 226 | – | – | 52/550 | – | |
FLAMINGO (CSR) [17] | DRV/r + ABC/3TC | 242 | 83.06 | 34 | 400a | 4.48a | 60/80 | 274.4 (SD:226.64) | 217/242 | 124/242 | 21/242 | 52/242 |
DRV/r + TDF/FTC | 104/162 | |||||||||||
DTG + ABC/3TC | 242 | 87.19 | 34 | 390a | 4.49a | 65/79 | 298.2 (SD:199.95) | 222/242 | 83/242 | 36/242 | 34/242 | |
DTG + TDF/FTC | 129/163 | |||||||||||
GS-236-0102 [18] | EFV + TDF/FTC | 352 | 89.77 | 38 | 382 (170.2) | 4.78 (0.6) | 287/352 | 273 | – | – | – | 61/352 |
EVG/c + TDF/FTC | 348 | 88.22 | 38 | 391 (188.6) | 4.73 (0.6) | 293/348 | 295 | – | – | – | 53/348 | |
GS-US-380-1489 [19] | BIC + TAF/FTC | 314 | 90.76 | 31 | 443a | 4.42a | 276/314 | 287 (SD:207) | 292/314 | 89/314 | 36/314 | 36/314 |
DTG + ABC/3TC | 315 | 89.52 | 32 | 450a | 4.51a | 283/315 | 288 (SD: 247) | 302/315 | 127/315 | 39/315 | 31/315 | |
GS-US-380-1490 [20] | BIC + TAF/FTC | 320 | 87.50 | 33 | 440a | 4.43a | 269/320 | 237 (SD:204) | 283/320 | 64/320 | 55/320 | 48/320 |
DTG + TAF/FTC | 325 | 88.62 | 34 | 441a | 4.45a | 281/325 | 281 (SD:209) | 288/325 | 92/325 | 33/325 | 36/325 | |
SINGLE (CSR) [21] | DTG + ABC/3TC | 414 | 83.82 | 36 | 334.5a | 4.67a | 332/414 | 325.3 (SE:10.46) | 376/414 | 184/414 | 44/414 | 72/414 |
EFV + TDF/FTC | 419 | 84.96 | 35 | 339a | 4.7a | 303/419 | 281.4 (SE:10.87) | 394/419 | 282/419 | 51/419 | 109/419 | |
SPRING-2 (CSR) [22] | DTG + ABC/3TC | 411 | 84.67 | 37 | 359a | 4.52a | 125/169 | 292.2 (SD:195.70) | 349/411 | 124/411 | 41/411 | 62/411 |
DTG + TDF/FTC | 207/242 | |||||||||||
RAL + ABC/3TC | 411 | 86.37 | 35 | 362a | 4.58a | 124/164 | 286.2 (SD:192.45) | 349/411 | 121/411 | 48/411 | 79/411 | |
RAL + TDF/FTC | 190/247 | |||||||||||
STaR (GS-US-264-0110) [23] |
EFV + TDF/FTC | 392 | 92.86 | 35 | 385 (187) | 4.8 (0.6) | 284/392 | 259 (SD:191) | 368/392b | – | – | 102/392 |
RPV + TDF/FTC | 394 | 92.89 | 37 | 396 (180) | 4.8 (0.7) | 307/394 | 278 (SD:189) | 362/394b | – | – | 78/394 | |
STARMRK [24] | EFV + TDF/FTC | 282 | 81.91 | 36.9 | 217.4 (133.6) | 5 (0.6) | 223/282 | 224.8 | 275/282 | 220/282 | 34/282 | 50/282 |
RAL + TDF/FTC | 281 | 80.78 | 37.6 | 218.9 (124.2) | 5.0 (0.6) | 228/281 | 239.6 | 266/281 | 132/281 | 40/281 | 36/281 | |
934 study [25] | EFV + 3TC/ZDV | 254 | 87.01 | 37 | 241a | 5.0a | – | 237 (SD: 136.4) | 180/254 | – | – | – |
EFV + TDF/FTC | 255 | 85.88 | 36 | 233a | 5.0a | – | 270 (SD: 147.5) | 185/257 | – | – | – | |
ABCDE study [26] | EFV + ABC/3TC | 115 | 74.8 | 38.4 | 203 (167) | 4.94 (0.60) | 70/115 | 263 | – | – | – | 40/115 |
EFV + 3TC/d4T | 122 | 78.7 | 38.5 | 223 (177) | 4.92 (0.57) | 58/122 | 294 | – | – | – | 59/122 | |
ACTG A5142 [27] | EFV + CHOICE | 250 | 81.20 | 39 | 195 | 4.8 | 158/178 | 230 | – | – | – | – |
LPV/r + CHOICE | 253 | 76.68 | 37 | 190 | 4.8 | 136/177 | 287 | – | – | – | – | |
ACTG A5202 [28] (Clinicaltrials.gov) | ATV/r + ABC/3TC | 463 | 83.80 | 38 | 236a | 4.7 (0.7) | – | 250.3a | – | – | – | 141/463 |
ATV/r + TDF/FTC | 465 | 83.23 | 38.9 | 224a | 4.7 (0.7) | – | 251.5a | – | – | – | 123/465 | |
EFV + ABC/3TC | 465 | 78.92 | 38.4 | 225a | 4.7 (0.7) | – | 250.5a | – | – | – | 141/465 | |
EFV + TDF/FTC | 464 | 84.70 | 38.2 | 234a | 4.7 (0.7) | – | 220.5a | – | – | – | 121/464 | |
ARTEMIS [29] | DRV/r + TDF/FTC | 343 | 69.68 | 36 | 228a | 7.1a | 271/343 | 171a | – | – | 34/343 | 59/343 |
LPV/r + TDF/FTC | 346 | 69.65 | 35 | 218a | 6.2a | 246/346 | 188a | – | – | 55/346 | 81/346 | |
ASSERT [30] | EFV + TDF/FTC | 193 | 79.79 | 36 | 230a | 5.12a | 76/128 | 220a | – | – | – | 59/193 |
EFV + ABC/3TC | 192 | 82.81 | 38 | 240a | 5.01a | 57/112 | 235a | – | – | – | 77/192 | |
ATADAR [31] | ATV/r + TDF/FTC | 90 | 86.67 | 35 | 328 (205) | 4.8 (0.7) | – | 284 (SD:219) | – | – | 24/90 | – |
DRV/r + TDF/FTC | 88 | 88.64 | 37 | 341 (171) | 4.8 (0.8) | – | 298 (SD: 182) | – | – | 7/88 | – | |
CASTLE [32] | ATV/r + TDF/FTC | 440 | 68.64 | 34 | 205 | 5.01 | 308/440 | 268 | 355/441 | – | 61/441 | 72/438 |
LPV/r + TDF/FTC | 443 | 68.62 | 36 | 204 | 4.96 | 281/443 | 290 | 370/437 | – | 48/437 | 95/440 | |
GS-236-0103 [33] | ATV/r + TDF/FTC | 355 | 89.01 | 39 | 366a | 4.8 (0.62) | 292/355 | 261 | – | – | 50/355 | 55/355 |
EVG/c + TDF/FTC | 353 | 91.78 | 38 | 351a | 4.8 (0.61) | 294/353 | 256 | – | – | 34/353 | 49/353 | |
HEAT ([34], clinicaltrials.gov) | LPV/r + ABC/3TC | 343 | 83.97 | 38 | 214a | 4.903a | 206/343 | 250a | 274/343 | – | 42/343 | 109/343 |
LPV/r + TDF/FTC | 345 | 80.00 | 38 | 193a | 4.844a | 200/345 | 246.5a | 276/345 | – | 45/345 | 124/345 |
a Median was used instead of mean
b Reported as treatment emergent adverse events, assumed to be equivalent to other reported AEs