Table 1.
Phase 3 clinical trials of integrase strand transfer inhibitor (INSTI)-based regimens as first-line therapy.
| INSTI | Clinical Trial | Treatment Groups (n) | Week 48 Treatment Outcome (HIV-1 RNA <50 Copies/mL) | Interpretation | Reference |
|---|---|---|---|---|---|
| RAL | STARTMRK | RAL (BID) + FTC/TDF (n = 281) vs. EFV + FTC/TDF (n = 282) | 86.1% vs. 81.9% (difference 4.2%, 95% CI −1.9 to 10.3) | Non-inferiority | [29] |
| QDMRK | RAL (QD) + FTC/TDF (n = 382) vs. RAL (BID) + FTC/TDF (n = 388) | 83.2% vs. 88.9% (difference −5.7%, 95% CI −10.7 to −0.83) | Not non-inferiority | [30] | |
| EVG | GS-US-236-0102 | EVG/COBI/FTC/TDF (n = 348) vs. EFV/FTC/TDF (n = 352) | 87.6% vs. 84.1% (difference 3.6%, 95% CI –1.6 to 8.8) | Non-inferiority | [31] |
| GS-US-236-0103 | EVG/COBI/FTC/TDF (n = 353) vs. ATV + RTV + FTC/TDF (n = 355) | 89.5% vs. 86.8% (difference 3.0%, 95% CI –1.9 to 7.8). | Non-inferiority | [32] | |
| DTG | SPRING-2 | DTG + [FTC/TDF or ABC/3TC] (n = 411) vs. RAL + [FTC/TDF or ABC/3TC] (n = 411) | 87.8% vs. 85.4% (difference 2.5%; 95% CI –2.2 to 7.1). | Non-inferiority | [33] |
| SINGLE | DTG + ABC/3TC (n = 414) vs. EFV/FTC/TDF (n = 419) | 87.9% vs. 80.7% (difference 7%, 95% CI 2 to 12) | Non-inferiority with secondary superiority | [34] | |
| FLAMINGO | DTG + [FTC/TDF or ABC/3TC] (n = 242) vs. DRV + RTV + [FTC/TDF or ABC/3TC] (n = 242) | 89.7% vs. 82.6% (difference 7.1%, 95% CI 0.9 to 13.2) | Non-inferiority with secondary superiority | [35] |
RAL = raltegravir; BID = twice a day; FTC = emtricitabine; QD = once a day; EVG = elvitegravir; DTG = dolutegravir; CI = confidence interval; RTV = ritonavir; 3TC = lamivudine; TDF, tenofovir disoproxil fumarate; EFV, efavirenz; COBI, cobicistat; ATV, atazanavir; ABC, abacavir; DRV, darunavir.