Table 2.
Main clinical trials comparing two- versus three-drug regimens for HIV infection.
| Clinical Trial | 2DR Arm | Comparator | Subject Population | Sample Size | Follow-Up | HIV-RNA ≤ 50 cp/mL, Absolute Risk Difference (95% CI) | Virological Response in 2DR Arm vs. Comparator |
|---|---|---|---|---|---|---|---|
| GARDEL | LPV/r + 3TC | LPV/r + 2 NRTIs | Naive to ART | 214 vs. 202 | 48 weeks | 4.6 (–2.2 to 11.8) † | 88.3% vs. 83.7% † |
| OLE | LPV/r + 3TC | LPV/r + 2 NRTIs | Virologically suppressed | 118 vs. 121 | 48 weeks | 1.19 (–7.10 to 9.50) † | 88.0% vs. 87.0% † |
| SALT | ATV/r + 3TC | ATV/r + 2 NRTIs | Virologically suppressed | 133 vs. 134 | 96 weeks | 1.39 (–8.50 to 11.30) ‡ | 69.9% vs. 71.3% ‡ |
| ATLAS-M | ATV/r + 3TC | ATV/r + 2 NRTIs | Virologically suppressed | 133 vs. 133 | 48 weeks | 6.77 (–2.20 to 15.70) * | 89.5% vs. 79.7% * |
| DUAL-GESIDA 8014 | DRV/r + 3TC | DRV/r + 2 NRTIs | Virologically suppressed | 126 vs. 123 | 48 weeks | –3.79 (–10.90 to 3.30) * | 88.9% vs. 92.7% * |
| SECOND-LINE | LPV/r + RAL | LPV/r + 2 or 3 NRTIs | First-line virological failure | 270 vs. 271 | 48 weeks | 1.8 (–4.7 to 8.3) ¶ | 80.8% vs. 82.6% ¶ |
| SELECT | LPV/r + RAL | LPV/r + 2 or 3 NRTIs | First-line virological failure | 260 vs. 255 | 48 weeks | 3.4 (–8.4 to 1.5) ¶ | 89.7% vs. 87.6% ¶ |
| EARNEST | LPV/r + RAL | LPV/r + 2 or 3 NRTIs | First-line virological failure | 433 vs. 426 | 96 weeks | –0.1 (–5.0 to 4.8) § | 64.0% vs. 60.0% § |
| GEMINI 1 and 2 | DTG + 3TC | DTG + FTC/TDF | Naive to ART | 719 vs. 722 | 48 weeks | –1.7 (–4.4 to 1.1) * | 91.0% vs. 93.0% * |
| TANGO | DTG + 3TC | TAF-based 3DR | Virologically suppressed | 369 vs. 372 | 48 weeks | –0.3 (–1.2 to 0.7) * | 93.2% vs. 93.0% * |
| SWORD 1 and 2 | DTG + RPV | 3DR | Virologically suppressed | 516 vs. 512 | 48 weeks | –0.2 (–3.0 to 2.5) * | 95.0% vs. 95.0% * |
| DUALIS | DTG + bDRV | DRV-based 3DR | Virologically suppressed | 131 vs. 132 | 48 weeks | –1.6 (–9.9 to 6.7) * | 86.3% vs. 87.9% * |
| NEAT001/ANRS 143 | RAL + DRV/r | DRV/r + FTC/TDF | Naive to ART | 401 vs. 404 | 123 weeks | 4.0 (–0.8 to 8.8) †† | 87.6 % vs. 89.7% †† |
| PROBE-2 | bDRV + RPV | 3DR | Pre-treated | 80 vs. 80 | 24 weeks | –3.75 (–11.63 to 5.63) * | 90.0% vs. 93.8% * |
| FLAIR | CAB + RPV | DTG/3TC/ABC | Pre-treated | 283 vs. 283 | 48 weeks | 0.4 (–3.7 to 4.5) * | 93.6% vs. 93.3% * |
2DR: two-drug regimen; LPV/r: ritonavir-boosted lopinavir; 3TC: lamivudine; NRTIs: nucleoside/nucleotide reverse transcriptase inhibitors; ATV/r: ritonavir-boosted atazanavir; DRV/r: ritonavir-boosted darunavir; RAL: raltegravir; FTC/TDF: emtricitabine/tenofovir-disoproxil-fumarate; DTG: dolutegravir; TAF: tenofovir alafenamide; 3DR: three-drug regimen; RPV: rilpivirine; bDRV: boosted-darunavir; CAB: cabotegravir; DTG/3TC/ABC: dolutegravir/abacavir/lamivudine. † Intention-to-treat, exposed, snapshot; ‡ Time to loss of virological response (TLOVR); * US Food and Drug administration (FDA) snapshot algorithm; ¶ Custom analysis equivalent to FDA snapshot algorithm; § Custom composite end-point; †† Kaplan–Meier estimated proportions analysis.