TABLE 1.
Characteristics of studies included in the analysis.
| First author, year | Study sites | Study design | Study population | Treatment arms | CD4+ Count (cells/mm3) at baseline | Number of participants with TE‐RAMs | Number of TE‐RAMs | Sample size | Number of DC‐AEs | Sample size |
|---|---|---|---|---|---|---|---|---|---|---|
| Daar 2018 [28] | 121 outpatient centers in 10 countries (Australia, Belgium, Canada, the Dominican Republic, France, Germany, Italy, Spain, the United Kingdom and the United States) | Randomized, open‐label, multicenter, active‐controlled, noninferiority phase 3 trial | Virologically suppressed adults | bPI + 2 NRTIs | 626 (437–821) | 1 | 1 | 287 | 1 | 287 |
| B/F/TAF | 617 (469–809) | 0 | 0 | 290 | 2 | 290 | ||||
| Molina 2018 [29] | 96 outpatient centers in 9 countries (Australia, Belgium, Canada, France, Germany, Italy, Spain, the United Kingdom and the United States) | Randomized, double‐blind, multicenter, active‐controlled, noninferiority phase 3 trial | Virologically suppressed adults | DTG/ABC/3TC | 661 (478–874) | 0 | 0 | 281 | 2 | 281 |
| B/F/TAF | 732 (554–936) | 0 | 0 | 282 | 6 | 282 | ||||
| Sax 2021 [30] | 94 locations (the United States) | Randomized, double‐blind, multicenter, active‐controlled, noninferiority phase 3 trial | Virologically suppressed adults | DTG + 2 NRTIs | 642 (462–791) | 0 | 0 | 281 | 6 | 281 |
| B/F/TAF | 659 (486–885) | 0 | 0 | 284 | 6 | 284 | ||||
| Arribas 2014 [31] | 86 sites in Europe and North America | Randomized, open‐label, multicenter, noninferiority phase 3b trial | Virologically suppressed individuals on ART | bPI + 2 NRTIs | 585 (445–770) | 0 | 0 | 139 | 4 | 140 |
| E/C/F/TXF | 564 (423–757) | 0 | 0 | 290 | 6 | 293 | ||||
| Hodder 2018 [32] | 99 locations (the United States) | Randomized, open‐label multicenter trial | Virologically suppressed women | bPI + 2 NRTIs | NR | 0 | 0 | 53 | 1 | 53 |
| E/C/F/TXF | NR | 0 | 0 | 159 | 1 | 159 | ||||
| Kityo 2019 [33] | 58 outpatient centers in the Dominican Republic, Puerto Rico, the Russian Federation, Thailand, Uganda and the United States | Randomized, open‐label, multicenter, active‐controlled, noninferiority phase 3 trial | Virologically suppressed women | E/C/F/TXF | 704 (546–878) | 1 | 1 | 223 | 0 | 223 |
| B/F/TAF | 667 (532–852) | 0 | 0 | 234 | 0 | 234 | ||||
| Mills 2016 a [34] | 168 sites in 19 countries in North America, Europe, Latin America, Asia and Australia | Randomized, open‐label, multicenter, active‐controlled noninferiority trial | Virologically suppressed adults | bPI + 2 NRTIs | 662 (525–831) | 0 | 0 | 199 | N/A | N/A |
| E/C/F/TXF | 675 (520–833) | 1 | 1 | 959 | N/A | N/A | ||||
| Pozniak 2014 a [35] | 72 sites in Australia, Europe and North America | Randomized, open‐label, multicenter phase 3b trial | Virologically suppressed adults | EFV/FTC/TDF | 562 (401–750) | 0 | 0 | 100 | N/A | N/A |
| E/C/F/TXF | 561 (450–722) | 0 | 0 | 290 | N/A | N/A | ||||
| Swindells 2020 a [7] | 115 locations (the United States) | Randomized, open‐label, multicenter parallel‐group trial | Treatment‐experienced, virologically suppressed adults (aged ≥18 years) | E/C/F/TXF | 680 (133–2089) | 1 | 1 | 75 | N/A | N/A |
| CAB + RPV Q4W | 684 (94–1954) | 1 | 2 | 308 | N/A | N/A | ||||
| Overton 2021 [8] | 13 countries (Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the United States) | Randomized, open‐label, multicenter, parallel‐group, noninferiority phase 3b trial | Treatment‐experienced, virologically suppressed (plasma HIV‐1 RNA <50 copies/mL) adults | CAB + RPV Q4W | 688 (523–878) | 2 | 5 | 523 | 13 | 523 |
| CAB + RPV Q8W | 642 (499–827) | 8 | 12 | 522 | 12 | 522 | ||||
| Ramgopal 2023 [9] | 118 clinical centers in 14 countries (Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Japan, the Netherlands, Spain, Switzerland, the United Kingdom and the United States) | Randomized, open‐label, multicenter, active‐controlled, noninferiority phase 3b trial | Virologically suppressed adults | B/F/TAF | 640 (459–846) | 0 | 0 | 223 | 2 | 227 |
| CAB + RPV Q8W | 649 (477–850) | 3 | 6 | 447 | 25 | 454 | ||||
| Llibre 2023 a [36] | 119 investigational centers in 17 countries (Argentina, Belgium, Brazil, Canada, China, Denmark, France, Germany, Italy, Mexico, Russia, South Africa, Spain, Sweden, Taiwan, the United Kingdom and the United States) | Randomized, open‐label, multicenter, noninferiority phase 3 trial | Virologically suppressed adults | EFV/FTC/TDF | 668 (94–1954) | 0 | 0 | 73 | N/A | N/A |
| DTG/3TC | 675 (154–2089) | 0 | 0 | 246 | N/A | N/A | ||||
| van Wyk 2020 a [37] | 133 locations (the United States) | Randomized, open‐label, multicenter, noninferiority phase 3 trial | Virologic suppressed adults | E/C/F/TXF | 720 (119–1810) | 0 | 0 | 249 | N/A | N/A |
| DTG/3TC | 682 (133–1904) | 0 | 0 | 369 | N/A | N/A | ||||
| Moyle 2024 [38] | 32 hospital‐based HIV clinics in 7 European countries (Belgium, France, Germany, Ireland, Italy, Spain and the United Kingdom) | Randomized, open‐label, multicenter, parallel 2‐arm trial | Virologically suppressed people with virus harbouring the Lys103Asn (K103N) mutation | bPI + 2 NRTIs | 617 (284–787) | 0 | 0 | 28 | 0 | 28 |
| DTG/RPV | 510 (284–715) | 0 | 0 | 95 | 3 | 95 |
Abbreviations: B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; bPI, boosted protease inhibitor; CAB + RPV, cabotegravir + rilpivirine; DC‐AEs, discontinuation due to adverse events; DTG, dolutegravir; DTG/3TC, dolutegravir/lamivudine; DTG/ABC/3TC, dolutegravir/abacavir/lamivudine; DTG/RPV, dolutegravir/rilpivirine; E/C/F/TXF, elvitegravir/cobicistat/emtricitabine/(tenofovir disoproxil fumarate or tenofovir alafenamide); EFV/FTC/TDF, efavirenz/emtricitabine/tenofovir disoproxil fumarate; N/A, not applicable; NR, not reported; NRTI, nucleoside reverse transcriptase inhibitor; Q4W, every 4 weeks; Q8W, every 8 weeks; RR, risk ratio; TE‐RAM, treatment‐emergent resistance‐associated mutation.
a
Study was excluded from the analysis of the rate of DC‐AEs due to insufficient data for each regimen in the control arm.