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Table 6 Second Generation INSTIs: Virologic Outcomes at Week 48 (FDA Snapshot)

From: A clinical review of HIV integrase strand transfer inhibitors (INSTIs) for the prevention and treatment of HIV-1 infection

 

SPRING-2

SINGLE

GEMINI-1 and -2

GS-US-380–1489

GS-US-380–1490

FLAIR

ATLAS

DTG + 2 NRTIs n = 411

RAL + 2 NRTIs n = 411

DTG + ABC/ 3TC n = 414

EFV/ FTC/ TDF n = 419

DTG/ 3TC n = 716

DTG + FTC/ TDF n = 717

DTG/ABC/3TC n = 315

BIC/ FTC/ TAF n = 314

DTG + FTC/ TAF n = 325

BIC/ FTC/ TAF n = 320

CAB n = 283

CAR n = 283

CAB n = 308

CAR n = 308

HIV-1 RNA < 50 copies/mL

361 (88%)

351 (85%)

364 (88%)

338 (81%)

655 (91%)

669 (93%)

293 (93%)

290 (92%)

302 (93%)

286 (89%)

265 (94%)

264 (93%)

285 (93%)

294 (95%)

Difference, % (95% CI)

2.5 (−2.2, 7.1)

7.4 (2.5, 12.3; P = 0.003)

−1.7 (−4.4, 1.1)

−0.6 (−4.8, 3.6; P = 0.78)

−3.5 (−7.9, 1; P = 0.12)

−0.4 (−2.8, 2.1)

0.7 (−1.2, 2.5)

HIV-1 RNA ≥ 50 copies/mL

8 (2%)

5 (1%)

6 (1%)

5 (1%)

8 (1%)

5 (1%)

8 (2.5%)

3 (1%)

4 (1%)

14 (4%)

6 (2%)

7 (2%)

5 (2%)

3 (1%)

No virologic data

30 (7%)

29 (7%)

29 (7%)

55 (13%)

41 (6%)

35 (5%)

14 (4%)

21 (7%)

19 (6%)

20 (6%)

12 (4%)

12 (4%)

18 (6%)

11 (4%)

INSTI Resistance Mutations Detected

None

T97T/A, E138E/D, V151V/I, N155H

None

N/A

None

None

None

None

None

None

Q148R; G140R

None

N155H; N155H + R263K

None

Reference

[92]

[93]

[96]

[97]

[98]

[99]

[100]

  1. Dash (-) indicates that information was not reported in the study results
  2. 3TC lamivudine, ABC abacavir, ATV atazanavir, BIC bictegravir, CAR current antiretroviral regimen, CI confidence interval, COBI cobicistat; DTG dolutegravir, EFV efavirenz, EVG elvitegravir, FTC emtricitabine, NRTI nucleoside reverse transcriptase inhibitor, RTV ritonavir, RAL raltegravir, TAF tenofovir alafenamide, TDF tenofovir disoproxil fumarate