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Table 2 Study population demographic characteristics at baseline for the ATLAS, FLAIR, pooled ATLAS/FLAIR and ATLAS-2M trials

From: Indirect comparison of 48-week efficacy and safety of long-acting cabotegravir and rilpivirine maintenance every 8 weeks with daily oral standard of care antiretroviral therapy in participants with virologically suppressed HIV-1-infection

 

ATLAS/FLAIR [12,13,14]

ATLAS-2M [15]

Statistical comparison

 

SoC

(n = 591)

CAB + RPV Q4W

(n = 591)

CAB + RPV Q4Wa

(n = 327)

CAB + RPV Q8Wa

(n = 327)

ATLAS/FLAIR vs ATLAS-2M

CAB + RPV Q4W

Age (years), median (range)

38 (18, 82)

38 (19, 74)

42 (19, 67)

41 (20, 83)

P = 0.0002b

Male, n (%)

423 (72)

429 (73)

252 (77)

254 (78)

P = 0.1563c

Race, n (%)

    

P = 0.0955d

 White

408 (69)

430 (73)

256 (78)

238 (73)

 

 Black/African American

133 (23)

109 (18)

45 (14)

57 (17)

 

 Asian

28 (5)

34 (6)

12 (4)

17 (5)

 

 Other

20 (3)

18 (3)

14 (4)

15 (5)

 

Ethnicity

     

 Hispanic/Latino, n (%)

74 (13)

63 (11)

42 (13)

54 (17)

P = 0.3309c

BMI (kg/m2), mean (SD)

25.9 (5.4)

25.7 (4.8)

26.2 (5.2)

26.2 (5.1)

P = 0.1451b

CD4-cell count (cells/mm2), mean (SD)

670.2 (273.2)

672.7 (264.3)

741.0 (288.8)

688.6 (266.0)

P = 0.0004b

CD4-cell count (cells/mm2), n (%)

    

P = 0.0526d

 < 350

54 (9)

42 (7)

17 (5)

25 (8)

 

 ≥ 350 to < 500

117 (20)

120 (20)

49 (15)

60 (18)

 

 ≥ 500

420 (71)

429 (73)

261 (80)

242 (74)

 

Baseline third active class, n (%)

     

 INSTI

382 (65)

385 (65)

141 (43)

136 (42)

P < 0.0001d

 NNRTI

155 (26)

155 (26)

156 (48)

151 (46)

 

 PI

54 (9)

51 (9)

30 (9)

40 (12)

  1. All statistical tests compare Q4W groups in ATLAS/FLAIR and ATLAS-2M
  2. ATLAS Antiretroviral Therapy as Long-Acting Suppression, ATLAS-2M ATLAS every 2 months, BMI body mass index, CAB cabotegravir, cART combination antiretroviral therapy, FLAIR First Long-Acting Injectable Regimen, HIV-1 human immunodeficiency virus type 1, INSTI integrase strand inhibitor, IQR interquartile range, m months, NA not applicable, NNRTI non-nucleoside reverse transcriptase inhibitor, PI protease inhibitor, Q4W every 4 weeks, Q8W every 8 weeks, RNA ribonucleic acid, RPV rilpivirine, SD standard deviation, SoC standard of care
  3. aParticipants with prior CAB + RPV LA exposure were excluded
  4. bWilcoxon Rank Sum test
  5. cFisher's exact test
  6. dChi-square test