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Table 4 Summary of results of the indirect comparison of CAB + RPV LA Q8W relative to SoC

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

 

Comparative effect measure (95% CI)

Relative risk

Risk difference, %

Odds ratio

HIV-1 RNA < 50 copies/mL at Week 48

1.01 (0.95, 1.06)

0.5 (− 4.40, 5.3)

1.04 (0.49, 2.22)

HIV-1 RNA ≥ 50 copies/mL at Week 48

1.10 (0.25, 4.90)

0.2 (− 2.20, 2.60)

1.10 (0.24, 5.03)

CD4 cell count change from baseline, per μLa at Week 48

 − 5.1 (− 40.0, 29.7)

No virologic data at Week 48

0.95 (0.42, 2.15)

 − 0.7 (− 4.90, 3.60)

0.94 (0.40, 2.24)

Discontinuations due to AEs at Week 48

1.48 (0.40, 5.46)

0.5 (− 2.5, 3.5)

1.49 (0.39, 5.65)

Any AE (excluding ISR) maintenance phase

1.03 (0.94, 1.13)

2.4 (− 4.90, 9.80)

1.15 (0.69, 1.90)

Serious AE (excluding ISR) maintenance phase

1.73 (0.73, 4.11)

2.4 (− 1.50, 6.3)

1.78 (0.72, 4.40)

Grade 3–5 AEs (excluding ISR) maintenance phase

1.68 (0.78, 3.61)

3.3 (− 1.3, 7.8)

1.74 (0.77, 3.92)

HIV-1 RNA < 50 copies/mL at Week 48 by baseline third active drug class

 INSTI

1.04 (0.96, 1.13)

3.8 (− 3.6, 11.2)

1.62 (0.57, 4.60)

 NNRTI

0.96 (0.89, 1.04)

 − 4.0 (− 11.4, 3.3)

0.50 (0.13, 1.99)

 PI

1.01 (0.83, 1.24)

1.0 (− 17.0, 19.1)

0.96 (0.11, 8.12)

HIV-1 RNA ≥ 50 copies/mL at Week 48 by baseline third active drug class

 INSTI

1.03 (0.13, 7.97)

0 (− 3.7, 3.7)

1.03 (0.13, 8.27)

 NNRTI

2.07 (0.08, 52.49)

1.3 (− 2.2, 4.9)

2.09 (0.08, 54.86)

 PIb

1.1 (− 7.8, 10.0)

  1. AE adverse event, ATLAS/FLAIR antiretroviral therapy as long-acting suppression/first long-acting injectable regimen, CAB cabotegravir, CI confidence interval, HIV-1 human immunodeficiency virus type 1, INSTI integrase strand inhibitor, ISR injection-site reaction, LA long-acting, NNRTI non-nucleoside reverse transcriptase inhibitor, OR odds ratio, PI protease inhibitor, Q8W every 8 weeks, RNA ribonucleic acid, RPV rilpivirine, RR relative risk, SoC standard of care
  2. aMean difference
  3. bValues could not be calculated for RR and OR as value for SoC in ATLAS/FLAIR was 0