“Randomized trial or prospective cohort”
AND
“zidovudine or stavudine or didanosine or lamivudine or tenofovir or emtricitabine or abacavir or GS-7340 or nevirapine or efavirenz or rilpivirine or doravirine or etravirine or MK-1439 or maraviroc or cenicriviroc or cobicistat or ritonavir or lopinavir or darunavir or atazanavir or fosamprenavir or tipranavir or indinavir or saquinavir or raltegravir or elvitegravir or dolutegravir or cabotegravir or bictegravir or GS-9883”
AND
“Untreated or naïve”
LIMIT
October 1, 2012 to July 31, 2017
Study name Reference Design Placebo NRTI backbone
3rd drug Follow-up (months)
Subjects exposed
(n) Antivir Ther 2011; 16: 759-69 RCT Yes TDF-FTC NVP 12 505 1100.1486
(VERxVE) TDF-FTC NVP 12 508
2NN Lancet 2004; 363: 1253-63 RCT No d4T-3TC EFV 12 381
d4T-3TC NVP 12 378
A1467003 Lancet HIV 2016; 3: e13-22 RCT No 2 NRTIs EFV 12 65
2 NRTIs EFV 12 67
2 NRTIs EFV 12 66
TDF-3TC EFV 12 99
AZT-3TC MVC 36 303
A4001026 (MERIT) J Infect Dis 2010; 201: 803-13 / AIDS 2014;
28: 717-25
RCT
Yes
AZT-3TC EFV 36 311
Nil rAZV 24 60 A4001078 6th IAS Conference 2011 (abstract
TUAB0103)
RCT
No
TDF-FTC rAZV 24 61
A5271015 RCT Yes TDF-FTC EFV 12 63
6th IAS Conference 2011 (abstract
TUAB0101) TDF-FTC LRV 12 130
ABCDE RCT No ABC-3TC EFV 24 115
J Acquir Immun Defic Syndr 2007; 44: 139-
47 d4T-3TC EFV 24 122
ACH443-015 CROI 2010 (abstract K-131) RCT Yes TDF-3TC EFV 24 37
TDF-ELV EFV 24 39
ACTG 384 N Engl J Med 2003; 349: 2293-303 RCT Yes AZT-3TC EFV 24 155
d4T-ddI EFV 24 155
AZT-3TC NFV 24 155
d4T-ddI NFV 24 155
ACTG 5095 N Engl J Med 2004; 350: 1850-61 RCT Yes AZT-3TC EFV 36 382
ACTG A5073 Clin Infect Dis 2010; 50: 1041-52 RCT No 2 NRTIs rLPV 12 159
2 NRTIs rLPV 12 161
ACTG A5142 N Engl J Med 2008; 358: 2095-106 RCT No 2 NRTIs rLPV 24 253
Nil rLPV 24 250
2 NRTIs EFV 24 250
ACTG A5175 PLoS Med 2012; 9: e1001290 RCT No AZT-3TC EFV 24 519
(PEARLS) TDF-FTC EFV 24 526
ACTG A5202 Ann Intern Med 2011; 154: 445-56 RCT Yes ABC-3TC rAZV 36 463
TDF-FTC rAZV 36 465
ABC-3TC EFV 36 465
TDF-FTC EFV 36 464
PLoS Med 2012; 9: e1001236 RCT No TDF-FTC rLPV 36 251 ACTG A5208
(OCTANE 2) TDF-FTC NVP 36 249
ACTG A5257 Ann Intern Med 2014; 161: 461-71 RCT No TDF-FTC rDRV 24 601
TDF-FTC rAZV 24 605
TDF-FTC RAL 24 603
ACTG A5262 AIDS 2011; 25: 2113-22 Cohort No Nil rDRV 12 112
RCT Yes FTC rDRV 12 119
ACTG A5303 Clin Infect Dis 2015; 61: 1179-88 / AIDS
2016; 30: 2315-21 TDF-FTC rDRV 12 111
RCT No AZT-3TC rLPV 12 94
Advanced HIV Mexico
J Acquir Immun Defic Syndr 2010; 53: 582-
88 AZT-3TC EFV 12 95
Advanz RCT No AZT-3TC rIDV 36 31
AIDS Res Hum Retrovirus 2010; 26: 747-57
AZT-3TC EFV 36 34
ADVANZ-3 RCT No TDF-FTC rAZV 12 30
TDF-FTC rLPV 12 29
J Acquir Immun Defic Syndr 2015; 69: 206- 15
TDF-FTC EFV 12 28
AI424-007 RCT No d4T-ddI NFV 12 103
J Acquir Immun Defic Syndr 2003; 32: 18-
29 d4T-ddI AZV 12 103
AI424-008 AIDS 2003; 17: 2603-14 RCT No d4T-3TC NFV 12 91
d4T-3TC AZV 12 181
AI424-034 J Acquir Immun Defic Syndr 2004; 36: RCT Yes AZT-3TC EFV 12 401
1001-19 AZT-3TC AZV 12 404
AI424-089 J Acquir Immun Defic Syndr 2008; 47: 161- RCT No d4T-3TC rAZV 24 95
67 d4T-3TC AZV 24 104
RCT No TDF-3TC rAZV 24 438
AI424-138 (CASTLE)
Lancet 2008; 372: 646-55
TDF-3TC rLPV 24 440
AI454-148 FDA Product Label (Videx): RCT No AZT-3TC NFV 12 253
http://www.accessdata.fda.gov/drugsatfd a_docs/abel/2006/020154s50,20155s39,2 0156s40,21183s16lbl.pdf
d4T-ddI NFV 12 503
AI454-152 RCT No AZT-3TC NFV 12 253
J Acquir Immun Defic Syndr 2002; 31: 399-
403 d4T-ddI NFV 12 258
AI455-096 43rd Annual ICAAC 2003 (abstract H843) RCT Yes d4T-3TC EFV 12 74
d4T-3TC EFV 12 76
AI455-099 43rd Annual ICAAC 2003 (abstract H843) RCT Yes d4T-3TC EFV 12 392
d4T-3TC EFV 12 391
Altair Clin Infect Dis 2010; 51: 855-64 RCT No TDF-FTC rAZV 12 105
TDF-FTC EFV 12 114
TDF-FTC ABC+AZT 12 103
ANRS 12-04 (IMEA 011)
AIDS 2003; 17: 1017-22 Cohort No ddI-3TC EFV 12 40
RCT No TDF rLPV 24 30
TDF-FTC EFV 24 30
TDF-FTC NVP 24 31
ANRS 12115 (DAYANA)
Antivir Ther 2014; 19: 51-9
TDF-FTC AZT 24 29
ANRS 12168 Cohort No AZT-3TC rLPV 12 47
8th IAS Conference 2015 (abstract
TUPEB266) TDF-3TC rLPV 12 94
ANRS 129 (BKVIR) 50th Annual ICAAC 2010 (abstract H232) Cohort No TDF-FTC EFV 12 69
APV109141 HIV Clin Trials 2009; 10: 356-67 RCT No ABC-3TC rFPV 12 106
ABC-3TC rFPV 12 106
RCT No ABC-3TC FPV 12 166
APV30001 (NEAT) J Acquir Immun Defic Syndr 2004; 35: 22-
32 ABC-3TC NFV 12 83
APV30002 (SOLO) AIDS 2004; 18: 1529-37 RCT No ABC-3TC rFPV 12 322
ARCA Cohort No TDF-FTC rAZV 24 321
TDF-FTC rLPV 24 694
J Antimicrob Chemother 2013; 68: 200-05
TDF-FTC EFV 24 639
ARES HIV Clin Trials 2005; 5: 235-45 RCT No ddI-3TC rSQV 12 23
ddI-3TC NVP 12 22
d4T-ddI NFV 12 26
ARIA RCT No TDF-FTC rAZV 12 247
21st International AIDS Conference 2016
(abstract THAB0205LB) ABC-3TC DTG 12 248
RCT No TDF-FTC rDRV 36 343
ARTEMIS (TMC- 114-C211)
AIDS 2008; 22: 1389-97 / HIV Med 2013;
14: 49-59 TDF-FTC rLPV 36 346
ARTEN Antivir Ther 2011; 16: 339-48 RCT No TDF-FTC rAZV 12 193
TDF-FTC NVP 12 376
ATADAR Clin Infect Dis 2015; 60: 811-20 / HIV Med 2014; 15: 330-08
RCT No TDF-FTC rDRV 24 88
ATHENA Clin Infect Dis 2015; 60: 143-53 Cohort No TDF-3TC EFV 36 535
TDF-3TC NVP 36 193
TDF-FTC EFV 36 3343
TDF-FTC NVP 36 669
AVANTI 2 AIDS 2000; 14: 367-74 RCT Yes AZT-3TC IDV 12 52
BI1046 (INCAS) JAMA 1998; 279: 930-37 RCT Yes AZT-ddI NVP 12 51
RCT No d4T-ddI NVP 24 85
d4T-ddI 3TC 24 104
BI1129 (ATLANTIC)
AIDS 2003; 17: 987-99
d4T-ddI IDV 24 94
BI1182.33 RCT No TDF-3TC rLPV 12 185
TDF-3TC rTPV 12 186
8th International Congress on Drug Therapy 2006 (abstract PL13.4) / PloS One
2016; 11: e0144917 TDF-3TC rTPV 12 187
RCT Yes TAF-FTC DTG 12 33
BICTEGRAVIR Phase 2 (GS-9883)
CROI 2017 (abstract 41)
TAF-FTC BIC 12 65
RCT Yes AZT-3TC IDV 12 103
BMS-001 (START 1) AIDS 2000; 14: 1591-600
d4T-3TC IDV 12 101
AIDS 2000; 14: 1601-10 RCT Yes AZT-3TC IDV 12 103
BMS-002 (START 2)
d4T-ddI IDV 12 102
CADIRIS Lancet HIV 2014; 1: e60-e67 Cohort No TDF-FTC EFV 12 136
CARINEMO Lancet Infect Dis 2013; 13: 303-12 RCT No d4T-3TC EFV 12 285
d4T-3TC NVP 12 285
CCTG589 6th IAS Conference 2011 (abstract RCT No Nil rLPV 12 26
CDB336) TDF-FTC EFV 12 25 Chelsea
Westminster
Antivir Ther 2006; 11: 73-78 RCT No AZT-3TC EFV 12 56
RCT No ABC-3TC EFV 24 192
CNA109586 (ASSERT)
J Acquir Immun Defic Syndr 2010; 55: 49-
57 TDF-FTC EFV 24 193
RCT Yes ABC-3TC EFV 12 386
CNA30021 (ZODIAC)
J Acquir Immun Defic Syndr 2005; 38: 417-
25 ABC-3TC EFV 12 384
CNA30024 Clin Infect Dis 2004; 39: 1038-46 RCT Yes ABC-3TC EFV 12 324
AZT-3TC EFV 12 325
CNAAB3005 JAMA 2001; 285: 1155-63 RCT Yes AZT-3TC ABC 24 262
AZT-3TC IDV 24 264
CNAB3014 Curr Med Res Opin 2004; 20: 1103-14 RCT No AZT-3TC ABC 12 169
AZT-3TC IDV 12 173
CNAF3007 Antivir Ther 2003; 8: 163-71 RCT No AZT-3TC ABC 12 98
AZT-3TC NFV 12 97
COL100758 RCT No ABC-3TC rFPV 24 58
AIDS Res Hum Retrovirus 2009; 25: 395-
403 ABC-3TC rFPV 24 57
COL102060 (SHARE)
HIV Clin Trials 2008; 9: 152-63 Cohort No ABC-3TC rAZV 12 111
RCT No TDF-FTC rAZV 12 53
COL103952 (ALERT)
AIDS Res Ther 2008; 5: 5
TDF-FTC rFPV 12 53
COL111429 (SHIELD)
HIV Clin Trials 2010; 11: 260-69 Cohort No ABC-3TC RAL 24 35
COMBINE Antivir Ther 2002; 7: 81-90 RCT No AZT-3TC NVP 12 72
AZT-3TC NFV 12 70
CTN 177 RCT No AZT-3TC rLPV 24 25
J Acquir Immun Defic Syndr 2009; 50: 335-
37 AZT-3TC NVP 24 26
CVC AIDS 2016; 30: 869-78 RCT Yes TDF-FTC CVC 12 56
TDF-FTC CVC 12 59
TDF-FTC EFV 12 28
Danish AIDS 2003; 17: 2045-52 RCT No AZT-3TC rSQV 12 60
d4T-ddI ABC 12 60
DART AIDS 2006; 20: 1391-99 Cohort No AZT-3TC TDF 12 300
DAT'AIDS Cohort No ABC-3TC rAZV 24 319
ABC-3TC rDRV 24 239
TDF-FTC rDRV 24 1028
TDF-FTC rAZV 24 895
Medicine 2015; 94: e1668 / HIV Med 2016; 17: 380-84
TDF-FTC EFV 24 647
DMP 266-006 N Engl J Med 1999; 341: 1865-73 RCT No AZT-3TC EFV 36 422
AZT-3TC IDV 36 415
Nil IDV 36 429
DRC RCT No 2 NRTIs rLPV 24 216
AIDS 2014; 28: 1143-53 / CROI Conference
2014 (abstract 542) 2 NRTIs NVP 24 209
DRIVE AHEAD RCT Yes TDF-3TC DOR 12 364
9th IAS Conference 2017 (abstract
TUAB0104LB) TDF-FTC EFV 12 364
EARTH 2 J Acquir Immun Defic Syndr 2000; 25: 26- 35
RCT No d4T-3TC IDV 12 32
ENCORE RCT Yes TDF-FTC EFV 24 321
Lancet 2014; 383: 1474-82 / Lancet Infect
Dis 2015; 15: 793-802 TDF-FTC EFV 24 309
EPV20001 Clin Infect Dis 2004; 39: 411-18 RCT Yes AZT-3TC EFV 12 276
AZT-3TC EFV 12 278
RCT Yes ABC-3TC rLPV 24 343
EPZ104057 (HEAT) AIDS 2009; 23: 1547-56
TDF-FTC rLPV 24 345
RCT No ABC-3TC rAZV 24 54
EPZICOM- TRUVADA
Intern Med 2013; 52: 735-44
TDF-FTC rAZV 24 55
RCT No AZT-3TC ABC 12 139
ESS100327 (ACTION)
AIDS Res Ther 2009; 6: 3
AZT-3TC AZV 12 140
Lancet 2006; 368: 476-82 RCT No ABC-3TC rFPV 12 443
ESS100732
(KLEAN) ABC-3TC rLPV 12 444
ESS30009 J Infect Dis 2005; 192: 1921-30 RCT No ABC-3TC EFV 12 169
RCT No ABC-3TC rFPV 24 96
ESS40001 (CLASS) J Acquir Immun Defic Syndr 2006; 43: 284-
92 ABC-3TC EFV 24 97
ABC-3TC d4T 24 98
ESS40002 HIV Med 2006; 7: 85-98 RCT No AZT-3TC ABC 24 85
AZT-3TC NFV 24 88
d4T-3TC NFV 24 81
FLAMINGO Lancet 2014; 383: 2222-31 RCT No 2 NRTIs rDRV 24 242
2 NRTIs DTG 24 242
FOCUS J Int AIDS Soc 2006; 8: 36 RCT No 2 NRTIs rSQV 12 82
2 NRTIs EFV 12 83
FREE HIV Med 2015; 16: 122-31 Cohort No AZT-3TC rLPV 24 104
FTC301A JAMA 2004; 292: 180-90 RCT Yes d4T-ddI EFV 12 285
ddI-FTC EFV 12 286
GARDEL RCT No 2 NRTIs rLPV 12 202
Lancet Infect Dis 2014; 14: 572-80 / 20th International AIDS Conference 2014 (abstract WEPE080)
3TC rLPV 12 214
GEMINI RCT No TDF-FTC rLPV 12 170
J Acquir Immun Defic Syndr 2009; 50: 367-
74 TDF-FTC rSQV 12 167
GESIDA 3093 Clin Infect Dis 2008; 47: 1083-92 RCT No AZT-3TC EFV 12 183
ddI-3TC EFV 12 186
RCT Yes TAF-FTC rDRV 12 103
GILEAD-TAF-DRV (NCT01565850)
J Acquir Immun Defic Syndr 2015; 69: 439-
45 TDF-FTC rDRV 12 50
GS 104 / 111 RCT Yes TAF-FTC COBI+EVG 36 866
Lancet 2015; 385: 2606-15 / J Acquir Immun Defic Syndr 2016; 72: 58-64 / CROI 2015 (abstract 113LB) / CROI 2017
(abstract 453)
TDF-FTC COBI+EVG 36 867
GS-01-934 RCT No AZT-3TC EFV 36 243
N Engl J Med 2006; 354: 251-60 / J Acquir Immun Defic Syndr 2006; 43: 535-40 / J Acquir Immune Defic Syndr 2008; 47: 74-8
TDF-FTC EFV 36 244
GS-99-903 JAMA 2004; 292: 191-201 RCT Yes d4T-3TC EFV 36 301
TDF-3TC EFV 36 299
RCT Yes TDF-FTC COBI+AZV 12 50
GS-US-216-0105 AIDS 2011; 25: 1881-86
TDF-FTC rAZV 12 29
GS-US-216-114 RCT Yes TDF-FTC COBI-AZV 36 344
J Infect Dis 2013; 208: 32-9 / J Acquir Immun Defic Syndr 2015; 69: 338-40 / Curr HIV Res 2017; 15: 216-224
TDF-FTC rAZV 36 348
RCT Yes TDF-FTC COBI+EVG 36 348
GS-US-236-0102
Lancet 2012; 379: 2439-48 / J Acquir Immun Defic Syndr 2013; 63: 96-100 / J Acquir Immun Defic Syndr 2014; 65: e118- 20
TDF-FTC EFV 36 352
RCT Yes TDF-FTC rAZV 36 355
GS-US-236-0103
Lancet 2012; 379: 2429-38 / J Acquir Immun Defic Syndr 2013; 62: 483-6 / J Acquir Immun Defic Syndr 2014; 65: e121- 4
TDF-FTC COBI+EVG 36 353
RCT Yes TDF-FTC COBI+EVG 12 48
GS-US-236-0104 AIDS 2011; 25: F7-12
TDF-FTC EFV 12 23
RCT Yes TAF-FTC COBI+EVG 12 112
GS-US-292-0102 J Acquir Immun Defic Syndr 2013; 63: 96- 100 / J Acquir Immune Defic Syndr 2014;
67: 52-58
TDF-FTC COBI+EVG 12 58
RCT Yes ABC-3TC DTG 12 315
GS-US-380-1489 9th IAS Conference 2017 (abstract
MOAB0105LB) TAF-FTC BIC 12 314
RCT Yes TAF-FTC BIC 12 320
GS-US-380-1490 9th IAS Conference 2017 (abstract
TUPDB0201LB) TAF-FTC DTG 12 325
HAND CROI 2015 (abstract 56) RCT No AZT-3TC NVP 24 233
TDF-3TC EFV 24 233
HCTC RCT No TDF-3TC EFV 12 115
J Acquir Immun Defic Syndr 2015; 70: 495-
502 TDF-3TC EFV 12 115
HIV-NAT 003 J Acquir Immun Defic Syndr 2001; 27: 116- 23
RCT No AZT-3TC ddI 12 53
IMEA 040 RCT No TDF-FTC rDRV 12 61
J Antimicrob Chemother 2016; 71: 2252-
61 TDF-FTC rAZV 12 59
JAPAN AIDS 2013; 27: 839-48 Cohort No ABC-3TC rDRV 12 21
TDF-FTC rDRV 12 59
JO'BURG J Int AIDS Soc 2013; 16: 18794 / Trop Med Cohort No d4T-3TC EFV 24 2062
Int Health 2014; 19: 490-98 TDF-3TC EFV 24 1878 KALEAD J Antivir Antiretrovir 2010; 2: 056-062 RCT No 2 NRTIs rLPV 18 80
TDF rLPV 18 72
LAKE Antiviral Res 2010; 85: 403-8 RCT No ABC-3TC rLPV 12 63
ABC-3TC EFV 12 63
LATTE CROI 2015 (abstract 554LB) / Lancet Infect Dis 2015; 15: 1145-55 / 21st International AIDS Conference 2016 (abstract
THAB0206LB)
RCT Yes 2 NRTIs EFV 24 62
LORAN Open AIDS J 2011; 5: 44-50 RCT No AZT-3TC rLPV 12 35
LOREDA 6th IAS Conference 2011 (abstract CDB354)
Cohort No 3TC rLPV 12 39
Low Dose D4T HIV Med 2014; 15: 3-12 RCT No d4T-3TC EFV 12 20
d4T-3TC EFV 12 20
TDF-3TC EFV 12 20
M02-418 RCT No TDF-FTC rLPV 24 75
J Acquir Immun Defic Syndr 2006; 43: 153-
60 TDF-FTC rLPV 24 115
M05-730 RCT No TDF-FTC rLPV 24 331
J Acquir Immun Defic Syndr 2009; 50: 474-
81 TDF-FTC rLPV 24 333
HIV Clin Trials 2011; 12: 255-67 RCT No Nil rLPV 24 101 M10-336
(PROGRESS) TDF-FTC rLPV 24 105
M97-720 AIDS 2001; 15: 1-9 Cohort No d4T-3TC rLPV 12 100
M98-863 N Engl J Med 2002; 346: 2039-46 RCT Yes d4T-3TC rLPV 12 326
d4T-3TC NFV 12 327
M99-056 J Infect Dis 2004; 189: 265-72 RCT No d4T-3TC rLPV 12 19
d4T-3TC rLPV 12 19
METABOLIK RCT No TDF-FTC rDRV 12 34
AIDS Res Hum Retrovirus 2012; 28: 1184-
95 TDF-FTC rAZV 12 31
MK0518-004 RCT Yes TDF-3TC RAL 24 160
J Acquir Immun Defic Syndr 2007; 46: 125-
33 TDF-3TC EFV 24 38
MK0518-021 Lancet 2009; 374: 796-806 / J Acquir RCT Yes TDF-FTC RAL 24 281
(STARTMRK) Immun Defic Syndr 2013; 63: 77-85 TDF-FTC EFV 24 282 Lancet Infect Dis 2011; 11: 907-15 RCT Yes TDF-FTC RAL 12 388 MK0518-071
(QDMRK) TDF-FTC RAL 12 382
MK-1439 RCT Yes TDF-FTC DOR 12 108
J Int AIDS Soc 2014; 17: 19532 / CROI 2016
(abstract 470) TDF-FTC EFV 12 108
AIDS 2016; 30: 1229-38 RCT Yes Nil rDRV 12 396
MODERN
A4001095 TDF-FTC rDRV 12 401
MONARK AIDS 2008; 22: 385-93 RCT No AZT-3TC rLPV 12 53
RCT No 3TC rLPV 12 100
MOPEB 0284 (China)
9th IAS Conference 2017 (abstract
MOPEB0284) TDF-3TC EFV 12 98
MVC-HAND CROI 2016 (abstract 423LB) RCT No TDF-FTC rAZV 12 30
N2R Clin Infect Dis 2009; 48: 1752-59 RCT No d4T-3TC EFV 12 71
d4T-3TC NVP 12 71
NEAT001 Lancet 2014; 384: 1942-51 RCT No Nil rDRV 24 401
TDF-FTC rDRV 24 404
BMC Infect Dis 2013; 13: 482 RCT No AZT-3TC EFV 24 68 NEW DELHI /
INDIA - TB AZT-3TC NVP 24 67
No Int J Clin Pract 2011; 65: 1240-49 RCT No TDF-FTC rAZV 12 77
TDF-FTC NVP 12 75
Nigerian ARV Program
J Acquir Immun Defic Syndr 2005; 40: 65- 69
Cohort No d4T-3TC NVP 12 50
HIV Med 2010; 11: 334-44 RCT Yes AZT-3TC NVP 12 300
NORA (DART
substudy) AZT-3TC ABC 12 300
NORTHIV Scand J Infect Dis 2013; 45: 543-51 RCT No 2 NRTIs rAZV 36 81
2 NRTIs rLPV 36 81
2 NRTIs EFV 36 77
PLoS ONE 2008; 3: e3918 Cohort No AZT-3TC NVP 12 64
AZT-ddI NVP 12 65
NVP China Cohort
d4T-3TC NVP 12 69
ONCE cohort Antivir Ther 2002; 6: 249-53 Cohort No ddI-3TC EFV 12 75
ONCE RCT Antivir Ther 2003; 8: 339-46 RCT No AZT-3TC EFV 12 34
AZT-3TC NFV 12 34
ONCEMRK RCT Yes TDF-FTC RAL 12 531
21st International AIDS Conference 2016 (abstract FRAB0103LB) / 9th IAS
Conference 2017 (abstract TULBPEB20)
TDF-FTC RAL 12 266
OPTIPRIM Lancet Infect Dis 2015; 15: 387-96 RCT No TDF-FTC rDRV 24 45
OZCOMBO 1 AIDS 2000; 14: 1171-80 RCT No AZT-3TC IDV 12 35
d4T-3TC IDV 12 34
d4T-ddI IDV 12 37
OZCOMBO 2 HIV Clin Trials 2002; 3: 177-85 RCT No AZT-3TC NVP 12 20
d4T-3TC NVP 12 22
d4T-ddI NVP 12 23
PADDLE 21st International AIDS Conference 2016 (abstract FRAB0104LB) / 9th IAS
Conference 2017 (abstract MOPEB0287)
Cohort No 3TC DTG 12 20
PROAB3001 Antivir Ther 2000; 5: 215-25 RCT Yes AZT-3TC APV 12 116
QUAD J Antimicrob Chemother 2005; 55: 246-51 RCT No AZT-3TC EFV 12 26
RADAR PLoS ONE 2014; 9: e106221 RCT No Nil rDRV 12 40
TDF-FTC rDRV 12 43
RAL-BMD HIV Clin Trials 2015; 16: 163-9 Cohort No TDF-FTC RAL 24 30
REALITY 21st International AIDS Conference 2016 (abstract FRAB0102LB)
RCT No TDF-FTC EFV 12 903
REFLATE Lancet Infect Dis 2014; 14: 459-67 RCT No TDF-3TC RAL 12 51
TDF-3TC EFV 12 51
REMAIN HIV Clin Trials 2016; 17: 17-28 Cohort No 2 NRTIs rAZV 36 517
SCAN AIDS 2000; 14: 2485-94 RCT No d4T-ddI NVP 12 44
d4T-ddI NVP 12 45
SENC HIV Clin Trials 2002; 3: 186-94 RCT No d4T-ddI EFV 12 31
d4T-ddI NVP 12 36
SINGLE RCT Yes ABC-3TC DTG 36 414
N Engl J Med 2013; 369: 1807-18 / J Acquir
Immun Defic Syndr 2015; 70: 515-19 TDF-FTC EFV 36 419
17th AIDS Conference 2008 (abstract MOPE0046)
Cohort No AZT-3TC EFV 36 1416
South African Workplace HIV
Program ddI-3TC NVP 12 70
SPARTAN HIV Clin Trials 2012; 13: 119-30 RCT No TDF-FTC rAZV 12 30
Nil AZV 12 63
RCT No 2 NRTIs DTG 24 155
SPRING-1 (ING112276)
Lancet Infect Dis 2012; 12: 111-18 / AIDS
2013; 27: 1771-78 2 NRTIs EFV 24 50
SPRING-2 RCT Yes ABC-3TC DTG 24 169
ABC-3TC RAL 24 164
Lancet 2013; 381: 735-43 / Lancet Infect Dis 2013; 13: 927-35 / CROI 2015 (abstract
550) TDF-FTC DTG 24 242
TDF-FTC RAL 24 247
STAR RCT Yes TDF-FTC RPV 24 394
20th International AIDS Conference 2014 (abstract WEPE064) / AIDS 2014; 28: 989- 97 / AIDS 2016; 30: 251-9
TDF-FTC EFV 24 392
STAR / STELLA Cohort No 2 NRTIs rLPV 12 140
20th International AIDS Conference 2014
(abstract WEPE069) 2 NRTIs rLPV 12 162
STR-MTR Cohort No TDF-FTC EFV 12 759
8th IAS Conference 2015 (abstract
TUBEB264) TDF-FTC EFV 12 483
SUPPORT BMC Infect Dis 2013; 13: 269 RCT No ABC-3TC rFPV 24 50
ABC-3TC EFV 24 51
Cohort No TDF-FTC rAZV 24 384
Swiss HIV Cohort Study: atazanavir
HIV Clin Trials 2014; 15: 92-103
TDF-FTC EFV 24 1097
Swiss HIV Cohort Study: rilpivirine
BMC Infect Dis 2017; 17: 476 Cohort No TDF-FTC RPV 24 48 Swiss HIV Cohort
Study: ritonavir
Scand J Infect Dis 2013; 45: 543-51 RCT No AZT-3TC RTV 24 23
TB-HAART PLoS ONE 2015; 10: e0122587 RCT No 2 NRTIs EFV 12 478
Thai indinavir Antivir Ther 2005; 10: 911-16 Cohort No d4T-3TC rIDV 24 80
AIDS 2011; 25: 2249-58 RCT Yes 2 NRTIs EFV 12 78
TMC125 VIR2038
(SENSE) 2 NRTIs ETR 12 79
TMC278-C204 AIDS 2010; 24: 55-65 RCT No 2 NRTIs EFV 24 89
2 NRTIs RPV 24 279 J Acquir Immun Defic Syndr 2012; 60: 33-
42
RCT Yes 2 NRTIs EFV 24 682
TMC278-TiDP6- C209/215
(ECHO/THRIVE) 2 NRTIs RPV 24 686
VACH Cohort No AZT-3TC EFV 36 409
J Antimicrob Chemother 2009; 63: 189-96
ddI-3TC EFV 36 219
VEMAN Clin Microbiol Infect 2015; 21: 510.e1-9 RCT No Nil rLPV 12 26
TDF-FTC rLPV 12 24
VESD HIV Clin Trials 2005; 6; 320-28 Cohort No ddI-3TC EFV 12 167
VIRGO Antivir Ther 2000; 5: 267-72 Cohort No d4T-ddI NVP 12 100
Ann Intern Med 2015; 162: 815-24 RCT No TDF-FTC EFV 12 86 VITAMIN D
(ACTG5280) TDF-FTC EFV 12 79
WAVES RCT Yes TDF-FTC rAZV 12 286
8th IAS Conference 2015 (abstract
MOLBPE08) / Lancet HIV 2016; 3: e410-20 TDF-FTC COBI+EVG 12 289
Zoledronate Clin Infect Dis 2016; 63: 663-71 RCT No TDF-FTC rAZV 12 29
TDF-FTC rAZV 12 34
Abbreviations
3TC, lamivudine; ABC, abacavir; APV, amprenavir; AZT, zidovudine; AZV, atazanavir; BIC, bictegravir; CVC, cenicriviroc; d4T, stavudine; ddI, didanosine; DTG, dolutegravir; COBI+AZV, cobicistat-boosted atazanavir; COBI+EVG, cobicistat-boosted elvitegravir; DOR, doravirine; EFV, efavirenz; ETR, etravirine; FPV, fosamprenavir; FTC, emtricitabine; IDV, indinavir; MVC, maraviroc; NFV, nelfinavir; NRTI, nucleos(t)ide reverse transcriptase inhibitor; NVP, nevirapine; RAL, raltegravir; rAZV, ritonavir-boosted atazanavir; rDRV, ritonavir-boosted darunavir; rFPV, ritonavir- boosted fosamprenavir; rIDV, ritonavir-boosted indinavir; rLPV, ritonavir-boosted lopinavir; RCT, randomised, controlled trial; RPV, rilpivirine;
rSQV, ritonavir-boosted saquinavir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate
Characteristics Groups n (%)
Subjects (n)
Weighted proportion (%)
Total (n) 354 (100%) 77999 100%
Studies
yes 304 (85.88%) 56846 72.88%
Randomised
no 50 (14.12%) 21153 27.12%
yes 108 (30.51%) 28369 36.37%
Placebo
no 246 (69.49%) 49630 63.63%
2 78 (22.03%) 6173 7.91%
3 134 (37.85%) 40046 51.34%
Phase
4 142 (40.11%) 31780 40.74%
academic 117 (33.05%) 32441 41.59%
industry 174 (49.15%) 38565 49.44%
Sponsorship
industry + academic 63 (17.80%) 6993 8.97%
1994-2000 87 (24.58%) 13681 17.54%
2001-2005 100 (28.25%) 29109 37.32%
2006-2010 108 (30.51%) 22418 28.74%
2011-2015 58 (16.38%) 12752 16.35%
Year
commenced
missing 1 (0.28%) 39 0.05%
Africa or Asia only 44 (12.43%) 11234 14.40%
Americas, Europe or
Australia only 228 (64.41%) 44670 57.27%
mixed 53 (14.97%) 14845 19.03%
Recruitment geography
Incomplete or missing 29 (8.19%) 7250 9.29%
48 weeks* 208 (58.76%) 31397 40.25%
96 weeks 105 (29.66%) 27784 35.62%
Maximum reported follow-
up 144 weeks 41 (11.58%) 18666 23.93%
<50 cp/mL plasma 332 (93.78%) 72240 92.62%
Viral load
endpoint other 22 (6.22%) 5759 7.38%
ITT 18 (5.08%) 7749 9.93%
ITT M=F 95 (26.83%) 17736 22.74%
ITT NC=F 108 (30.51%) 17466 22.39%
TLOVR 69 (19.49%) 18308 23.47%
Snapshot 63 (17.80%) 16692 21.40%
ITT analysis
missing 1 (0.28%) 48 0.06%
yes 312 (88.14%) 67628 86.70%
Published
no (abstract only) 42 (11.86%) 10371 13.30%
Eligibility
unrestricted 332 (93.79%) 75326 96.57%
restricted 11 (3.11%) 1221 1.57%
Prior IDU
missing 11 (3.11%) 1452 1.86%
unrestricted 329 (92.94%) 74858 95.97%
restricted 18 (5.08%) 2368 3.04%
Prior AIDS- defining illness
missing 7 (1.98%) 773 0.99%
unrestricted 168 (47.46%) 50567 64.83%
restricted 186 (52.54%) 27105 34.75%
CD4 count
missing 5 (1.41%) 327 0.42%
unrestricted 84 (23.73%) 23367 29.96%
restricted 261 (73.73%) 53715 68.87%
HIV viral load
missing 9 (2.54%) 917 1.18%
unrestricted 197 (55.65%) 42841 54.93%
restricted 155 (43.79%) 35052 44.94%
HIV genotype
missing 2 (0.56%) 106 0.14%
unrestricted 73 (20.62%) 23864 30.60%
restricted 233 (65.82%) 40747 52.24%
ALT/AST
missing 48 (13.56%) 13388 17.16%
unrestricted 115 (32.49%) 35708 45.78%
restricted 177 (50.00%) 31200 40.00%
Haemoglobin
missing 62 (17.51%) 11091 14.22%
Footnote
* Two groups reported data only to 18 months; data reported at 12 months were included.
Abbreviations
ALT / AST, alanine / aspartate aminotransferase; IDU, injection drug user; ITT, intention to treat;
ITT M=F, ITT missing equals failure; ITT NC=F, ITT non-completion equals failure; TLOVR, time to
loss of virological response
Characteristics Groups*
n (%)
Subjects*
n (%)
Mean (across groups)
% or mean (SD)
Mean (weighted)
% or mean (SD)
Antiretroviral therapy
overall 354 (100%). 77999 (100%). 5.5 (3.4) 4.8 (3.1)
1 7 (2.0%) 1275 (1.6%) 2.0% 1.6%
2 34 (9.6%) 13477 (17.3%) 9.6% 17.3%
3 77 (21.8%) 19532 (25.0%) 21.8% 25.0%
4 60 (17.0%) 13521 (17.3%) 17.0% 17.3%
5 41 (11.6%) 8792 (11.3%) 11.6% 11.3%
Pills per day
6 or more 135 (38.1%) 21402 (27.4%) 27.4%
overall 354 (100%). 77999 (100%). 1.7 (0.7) 1.6 (0.7) 1 136 (38.4%) 36247 (46.5%) 38.4% 46.5%
2 187 (52.8%) 35916 (46.0%) 52.8% 46.0%
Doses per day
3 or more 31 (8.8%) 5836 (7.5%) 8.8% 7.5%
unrestricted 98 (27.7%) 19032 (24.4%) 27.7% 24.4%
fasting only 103 (29.1%) 27669 (35.5%) 29.1% 35.5%
food only 129 (36.4%) 26075 (33.4%) 36.4% 33.4%
Dosing relative to food
fasting + food
24 (6.8%) 5223 (6.7%) 6.8% 6.7%
TDF/TAF-FTC 121 (34.2%) 34449 (44.2%) 34.2% 44.2%
Historical** 125 (35.3%) 21603 (27.7%) 35.3% 27.7%
ABC-3TC 37 (10.5%) 7560 (9.7%) 10.5% 9.7%
2 NRTIs*** 31 (8.8%) 6073 (7.8%) 8.8% 7.8%
TDF-3TC 22 (6.2%) 5816 (7.5%) 6.2% 7.5%
No NRTI 11 (3.1%) 1904 (2.4%) 3.1% 2.4%
NRTI backbone
Single NRTI 7 (2.0%) 594 (0.8%) 0.8% 0.8%
INSTI 33 (9.3%) 8941 (11.5%) 9.3% 11.5%
NNRTI 145 (41.0%) 38748 (49.7%) 41,0% 49.7%
PI (boosted) 120 (33.9%) 21914 (28.1%) 33.9% 28.1%
PI 40 (11.3%) 6178 (7.9%) 11.3% 7.9%
NRTI 13 (3.7%) 1800 (2.3%) 3.7% 2.3%
Anchor drug class
CCR5 3 (0.9%) 418 (0.5%) 0.9% 0.5%
Subjects
Age (years) 341 (96.3%) 77060 (98.8%) 36.6 (2.5) 36.9 (2.5) .
Male 349 (98.6%) 77699 (99.6%) 75.6 (18.3) 74.7 (18.1)
groups)
% or mean (SD)
% or mean (SD) white 278 (78.5%) 61085 (78.3%) 57.4 (27.4) 61.0 (22.6) black 272 (76.8%) 62610 (80.3%) 31.8 (26.3) 33.7 (27.5) Race
other 269 (76.0%) 57505 (73.7%) 13.7 (24.1) 11.5 (16.7) MSM 129 (36.4%) 31969 (41.0%) 49.5 (20.8) 54.2 (18.4) IDU 131 (37.0%) 31637 (40.6%) 10.1 (10.8) 7.1 (8.1) heterosexual 110 (31.1%) 26514 (34.0%) 39.4 (18.4) 35.4 (15.3) HIV risk factor
other 105 (29.7%) 25387 (32.6%) 5.3 (8.0) 4.1 (5.9)
CDC C 247 (69.8%) 52637 (67.5%) 67.5% 11.9 (14.8)
CD4 count (cells/mm
3) 349 (98.6%) 77208 (99.0%) 99.0% 262 (96) . log cp/mL 340 (96.1%) 71843 (92.1%) 4.8 (0.3) 4.8 (0.3) HIV viral load
≥100,000 cp/mL
256 (72.3%) 62512 (80.1%) 39.0 (16.5) 39.3 (12.9) Hepatitis B sAg + 217 (61.3%) 50366 (64.6%) 3.1 (3.6) 3.7 (3.5) Hepatitis C Ab + 207 (58.5%) 52516 (67.3%) 9.5 (9.3) 9.2 (7.4) Weight (kg) 134 (37.9%) 24967 (32.0%) 69.3 (6.8) 69.3 (6.4) .
Abbreviations
3TC, lamivudine; ABC, abacavir; CDC C, Centers for Disease Control Category C (AIDS-defining condition); CCR5, CCR5 receptor antagonist; FTC, emtricitabine; IDU, injection drug user; INSTI, integrase strand transfer inhibitor; MSM, men who have sex with men; NRTI, nucleos(t)ide reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI,
protease inhibitor; SD, standard deviation; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate
Footnotes
* For some characteristics, data were not reported for all 354 groups; the totals for each characteristic represents the number of groups and the proportion of subjects with data for a given characteristic.
** Historical NRTI backbones were defined as those comprising AZT-3TC (zidovudine- lamivudine), d4T-ddI (stavudine-didanosine), d4T-3TC, ddI-3TC, or AZT-ddI.
*** 2 NRTI-based regimens most commonly included AZT-3TC and TDF-FTC in earlier studies,
and TDF-FTC and ABC-3TC in more recent studies.
Efficacy Univariable analysis Multivariable analysis
% (SD) Coeff
., %
95% CI P P trend r2 (%)
Coeff.,
%
95% CI P P group
Study characteristics
yes 65.4 14.7 ref.
Randomised
no (cohort) 57.9 14.6 -7.5 -14.7, -0.3 0.04 3.7 yes 70.5 13.9 ref.
Placebo
no 60.9 14.3 -9.6 -14.4, -4.9 <0.0001 0.02 10.9 -6.3 -10.3, -2.4 0.002 0.002 2 73.7 13.9 5.6 -1.4, 12.6 0.12 <0.001 19.8 7.9 2.8, 13.0 0.03 <0.0001
3 68.1 13.2 ref. ref.
Phase
4 56.6 13.8 -11.5 -16.2, -6.7 <0.0001 -4.9 -2.6, -1.2 0.01
1994-2000 51.8 12.7 ref. <0.0001 30.1
2001-2005 62.6 12.7 10.9 5.1, 16.6 0.0002 2006-2010 71.3 12.7 19.5 13.6, 25.3 <0.0001 2011-2015 81.5 12.5 29.7 18.6, 40.8 <0.0001 Year
commenced
*
missing
ITT 66.6 13.1 -11.3 -22.2, -0.3 0.04 <0.0001 22.2 ITT M=F 57.6 13.5 -20.2 -27.0, -13.3 <0.0001
ITT NC=F 62.1 13.6 -15.7 -22.2, -9.2 <0.0001 TLOVR 63.1 13.1 -14.8 -21.4, -8.2 <0.0001 ITT analysis
Snapshot 77.8 12.9 ref.
Eligibility
unrestricted 66.8 14.4 ref.
restricted 60.6 14.9 -6.3 -11.2, -1.3 0.01 4.7 CD4 count
missing
unrestricted 57.0 12.7 ref.
restricted 73.0 12.5 16.0 11.9, 20.1 <0.0001 <0.0001 30.9 HIV
genotype
missing Antiretroviral therapy
., % (%) %
1 73.0 14.7 8.2 -20.9, 37.4 0.58 11.9 -10.3, 34.3 0.29 0.02 2 71.6 12.8 6.8 -0.6 14.2 0.07 -2.4 -8.0, 3.1 0.39
3 64.8 13.0 ref <0.0001 27.0
4 73.3 12.8 8.6 2.5, 14.7 0.006 1.1 -3.4, 5.5 0.64 5 64.6 13.0 -2.1 -8.7, 8.3 0.96 -2.1 -8.3, 4.2 0.52 Pills per day
6 or more 54.9 13.0 -9.9 -15.6, -4.2 0.0006 -6.4 -11.3, -1.5 0.01
1 70.3 13.6 ref. <0.0001 16.1
2 61.7 13.9 -8.7 -13.3, -4.0 0.0003
Doses per day
3 or more 49.0 13.6 -21.3 -30.8, -11.7 <0.0001
unrelated 63.9 14.6 ref. 0.02 7.2 ref. 0.03
fasting only 59.2 14.4 -4.6 -10.9, 1.6 0.15 -5.7 -10.3, -1.0 0.02 food only 67.7 14.4 3.8 -3.6, 16.4 0.21 0.9 -4.1, 5.8 0.73 Dosing
relative to food, %
fasting + food
70.2 14.4 6.4 -2.0, -9.7 0.20 0.6 -6.4, 7.6 0.86
TDF/TAF-FTC 73.5 11.5 ref. <0.0001 41.5 ref. 0.0003
Historical** 50.8 11.9 -22.7 -27.4, -17.9 <0.0001 -13.0 -18.0, -8.0 <0.0001 ABC-3TC 63.4 11.9 -10.1 -16.3, -3.9 0.001 -7.2 -12.1, -2.4 0.004 2 NRTIs*** 68.2 11.6 -5.2 -11.6, 1.1 0.11 -3.1 -8.1, 1.9 0.23 TDF-3TC 68.9 11.6 -4.6 -13.7, 4.6 0.33 -4.8 -12.0, 2.3 0.18 Single NRTI 66.4 13.4 -7.1 -26.0, 11.8 0.46 -7.8 -23.9, 8.2 0.34 NRTI
backbone
No NRTI 62.2 11.6 -11.3 -22.0, -0.6 0.04 -3.7 -12.1, 4.7 0.38
INSTI 81.1 14.7 ref. <0.0001 38.9 ref. 0.003
NNRTI 61.8 19.0 -19.3 -25.2, -13.4 <0.0001 -9.1 -12.2, -1.6 0.01 PI (boosted) 65.8 18.4 -15.3 -21.3, -9.3 <0.0001 -13.0 -13.5, -0.8 0.03 PI 47.0 24.3 -34.1 -43.2, -25.1 <0.0001 -18.8 -21.0, -3.2 0.008
NRTI 45.4 20.0 -35.7 -47.7, -23.8 <0.0001 -24.0 -29.9, -10.8 <0.0001 Anchor drug
class
CCR5 59.0 20.0 -22.1 -45.3, 1.1 0.06 -4.0 -22.7, 12.5 0.57 Subjects
CD4 count (per 100 5.0 3.0, 8.0 0.0001 10.4
., % (%) % cells/mm3 higher)
Male, % (SD) 0.2 0.02, 0.3 0.02 3.7
Multiple regression – R2=66.7%; I2 = 96.7%
Abbreviations
3TC, lamivudine; ABC, abacavir; FTC, emtricitabine; IDU, injection drug user; INSTI, integrase strand transfer inhibitor; ITT, intention to treat; ITT M=F, intention to treat missing equals failure; ITT NC=F, intention to treat non-completion equals failure; MSM, men who have sex with men;
NRTI, nucleos(t)ide reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; SD, standard deviation; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; TLOVR, time to loss of virological response
Footnotes
Variables not listed are those not significant on univariate analysis: study sponsorship; recruitment geography; publication status; eligibility based on prior injection drug use, prior AIDS-defining illness, HIV viral load, liver transaminases, and haemoglobin; baseline age, baseline race, risk factor for HIV acquisition, AIDS-defining illness prior to baseline and baseline HIV viral load).
For some characteristics, data were not reported for all 145 groups; the totals for each characteristic represents the number of groups and the proportion of subjects with data for a given characteristic.
* excluded from multivariate analysis (see Methods)
** thymidine analogue-based NRTI backbones were AZT-3TC (zidovudine-lamivudine), d4T-ddI (stavudine-didanosine), d4T-3TC, ddI-3TC, and AZT-ddI
*** 2 NRTI-based regimens most commonly included AZT-3TC and TDF-FTC in earlier studies, and TDF-FTC and ABC-3TC in more recent studies
% SD Coeff ., %
95% CI P P trend r2 (%)
Coeff.,
%
95% CI P P group
Study characteristics
yes 64.1 13.7 ref. 11.1 ref
Randomised
no (cohort) 47.8 13.5 -16.2 -30.1, -2.4 0.02 -8.7 -15.4, -2.0 0.01
yes 70.7 11.7 ref. 35.0
Placebo
no 53.7 12.0 -17.0 -23.7, -10.2 <0.0001 0.02 2 72.8 13.1 8.0 -3.4, 19.4 0.17 0.001
3 64.8 12.5 ref. 24.4
Phase
4 49.0 13.2 -15.8 -25.1, -6.6 0.0008
academic 57.0 14.1 ref. 0.04 8.3
industry 65.9 13.8 8.9 0.8, 11.7 0.07 Sponsorship
industry + academic
Null
1994-2000 47.4 10.9 ref. <0.0001 43.6
2001-2005 59.8 11.3 12.4 3.2, 21.7 0.008 2006-2010 72.4 10.9 25.0 15.1, 35.0 <0.0001 2011-2015 82.0 10.7 34.6 17.8, 51.5 <0.0001 Year
commenced
*
missing
ITT Null Null <0.0001
ITT M=F 51.3 12.6 -22.2 -36.7, -7.8 0.003 ITT NC=F 61.3 13.1 -12.2 -21.8, -2.6 0.01 TLOVR 59.2 12.8 -14.3 -24.1, -4.4 0.004 ITT analysis
Snapshot 73.5 12.6 ref. 22.9
Eligibility
unrestricted 62.6 14.5
restricted Null
Prior IDU
missing
., % (%) % unrestricted 62.6 14.5
restricted Null
Prior AIDS- defining
illness missing
unrestricted 65.9 13.1 ref. ref.
restricted 52.3 13.5 -13.6 -22.4, -4.8 0.002 18.2 -10.5 -14.5, -6.6 <0.0001 CD4 count
missing
unrestricted 48.1 13.6 ref.
restricted 66.1 13.0 17.9 8.1, 27.8 0.0003 21.9 HIV viral
load
missing
unrestricted 50.7 11.2 ref.
restricted 70.2 10.9 19.5 13.1, 25.9 <0.0001 44.8 HIV
genotype
missing Antiretroviral therapy
1 Null Null
2 79.2 10.3 20.2 10.6, 29.8 <0.0001 8.1 2.8, 13.4 0.003
3 59.0 10.4 ref <0.0001 51.8 0.001
4 70.6 10.2 11.6 4.1, 19.2 0.003 3.3 -0.6, 7.3 0.10 5 66.0 10.6 7.0 -4.5, 18.5 0.23 0.8 -8.3, 9.9 0.86 Pills per day
6 or more 46.4 10.4 -12.6 -21.0, -4.2 0.003 -7.4 -13.6, -1.3 0.02
1 70.2 10.7 ref. <0.0001 46.5
2 58.8 10.9 -11.4 -17.6, -5.1 0.0004
Doses per day
3 or more
27.0 10.5
-43.2 -58.5, -27.9 <0.0001
unrelated 56.2 13.0 ref. 7.2 ref.
fasting only 57.4 13.1 1.2 -9.1, 11.5 0.82 -5.7
food only 68.9 13.0 12.7 2.7, 22.6 0.01 0.9
Dosing relative to food, %
fasting +
food 72.8 13.0
16.6 -0.3, 33.4 0.05 0.6
NRTI TDF/TAF-FTC 71.2 8.9 ref. <0.0001 63.3 ref. 0.0003
., % (%) %
Historical** 47.2 9.3 -24.0 -30.4, -17.6 <0.0001 -5.9 -12.7, 0.8 0.08 ABC-3TC 65.0 8.8 -6.2 -16.9, 4.4 0.25 -4.7 -9.9, 0.5 0.08 2 NRTIs*** 58.3 9.7 -12.9 -21.5, -4.3 0.003 -4.7 -9.9, 0.6 0.08 TDF-3TC 74.1 9.6 2.8 -8.6, 14.3 0.63 12.3 2.9, 21.7 0.01
Single NRTI Null Null Null
backbone
No NRTI 31.0 8.8 -40.2 -57.9, -22.5 <0.0001 2.1 -11.0, 15.1 0.76
INSTI 78.1 9.3 ref. <0.0001 60.3 ref. <0.0001
NNRTI 58.8 9.5 -19.2 -26.3, -12.2 <0.0001 -8.6 -13.1, -4.2 0.0002 PI (boosted) 63.4 9.5 -14.7 -22.3, -7.0 0.0002 -5.6 -10.1, -1.1 0.02
PI 27.0 9.2 -51.1 -65.0, -37.2 <0.0001 -28.7 -39.0, -18.4 <0.0001
NRTI Null Null Null
Anchor drug class
CCR5 55.0 N=1 -23.1 -42.3, -3.9 0.02 -14.5 -26.4, -2.6 0.02
Subjects
CD4 count (per 100 cells/mm3 higher)
0.8 0.4, 1.3 0.0001 26.0
Age, years -2.0 -3.9, -0.08 0.04 7.4 -1.0 -1.8, -0.2 0.02
HIV risk factor, MSM % (SD) 0.4 0.03, 0.7 0.04 15.1
CDC C, % (SD) -0.4 -0.7, -0.2 0.0002 28.7
HIV viral load log cp/mL plasma
-21.4 -38.8, -3.9 0.02 10.0
Multiple regression – R2=64.3%; I2 = 94.2%
Abbreviations
3TC, lamivudine; ABC, abacavir; FTC, emtricitabine; IDU, injection drug user; INSTI, integrase strand transfer inhibitor; ITT, intention to treat; ITT M=F, intention to treat missing equals failure; ITT NC=F, intention to treat non-completion equals failure; MSM, men who have sex with men;
NRTI, nucleos(t)ide reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; Null, no data reported; PI, protease inhibitor; SD, standard deviation; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; TLOVR, time to loss of virological response
defining illness).
For some characteristics, data were not reported for all 48 groups; the totals for each characteristic represents the number of groups and the proportion of subjects with data for a given characteristic.
* excluded from multivariate analysis (see Methods)
** thymidine analogue-based NRTI backbones were AZT-3TC (zidovudine-lamivudine), d4T-ddI (stavudine-didanosine), d4T-3TC, ddI-3TC, and AZT-ddI
*** 2 NRTI-based regimens most commonly included AZT-3TC and TDF-FTC in earlier studies, and TDF-FTC and ABC-3TC in more recent studies
