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Table 1 Week 144 efficacy and safety data from the included trials

From: An indirect comparison of 144-week efficacy, safety, and tolerability of dolutegravir plus lamivudine and second-generation integrase inhibitor–based, 3-drug, single-tablet regimens in therapy-naive people with HIV-1

Outcome, n (%)a

GEMINI-1/-2 (pooled analysis)

GS-US-380-1489

GS-US-380-1490

DTG + 3TC (N = 716)

DTG + TDF/FTC (N = 717)

BIC/FTC/TAF (N = 314)

DTG/ABC/3TC (N = 315)

DTG + TAF/FTC (N = 325)

BIC/FTC/TAF (N = 320)

HIV-1 RNA < 50 copies/mLb

584 (81.6)

599 (83.5)

256 (81.5)

265 (84.1)

273 (84.0)

262 (81.9)

HIV-1 RNA ≥ 50 copies/mLb

23 (3.2)

21 (2.9)

2 (0.6)

9 (2.9)

10 (3.1)

15 (4.7)

Change in CD4 + cell count from baseline, mean (SD), cells/µL

300 (203.5)

298 (227.1)

299 (224.9)

317 (219.5)

289 (218.5)

278 (236.6)

Discontinuations

134 (18.7)

123 (17.2)

54 (17.2)

48 (15.2)

47 (14.5)

59 (18.4)

AEs

613 (85.6)

625 (87.2)

300 (95.5)

304 (96.5)

300 (92.3)

291 (90.9)

Grade 3–4 AEs

83 (11.6)

88 (12.3)

50 (15.9)

50 (15.9)

43 (13.2)

54 (16.9)

Serious AEs

76 (10.6)

85 (11.9)

41 (13.1)

53 (16.8)

40 (12.3)

63 (19.7)

Drug-related AEs

146 (20.4)

192 (26.8)

94 (29.9)

132 (41.9)

95 (29.2)

71 (22.2)

Discontinuations due to AEs

24 (3.4)

25 (3.5)

0 (0)

5 (1.6)

6 (1.8)

6 (1.9)

  1. ABC, abacavir; AE, adverse event; BIC, bictegravir; DTG, dolutegravir; FDA, US Food and Drug Administration; FTC, emtricitabine; TAF, tenofovir alafenamide; 3TC, lamivudine; TDF, tenofovir disoproxil fumarate
  2. aUnless otherwise specified. bFDA Snapshot algorithm