Table 3.
Summary of 48-week efficacy and safety data from the pooled ATLAS/FLAIR and ATLAS-2M trials considered for the indirect treatment comparison (full analysis set)
| ATLAS/FLAIR [12–14] | ATLAS-2M [15] | |||
|---|---|---|---|---|
| SOC (n = 591) |
CAB + RPV Q4W (n = 591) |
CAB + RPV Q4Wa (n = 327) | CAB + RPV Q8Wa (n = 327) | |
|
HIV-1 RNA < 50 copies/mL, n (%)b |
558 (94.4) | 550 (93.1) | 300 (91.7) | 306 (93.6) |
|
HIV-1 RNA ≥ 50 copies/mL, n (%)b |
10 (1.7) | 11 (1.9) | 5 (1.5) | 5 (1.5) |
| CD4-cell count (cells/μl), mean (SD) change from baseline | 48.2 (182.1) | 24.5 (191.3) | − 19.2 (204.9) | − 0.7 (150.6) |
| No virologic data at week 48c, n (%)b | 23 (3.9) | 30 (5.1) | 22 (6.7) | 16 (4.9) |
| Discontinuation due to AEs, n (%)d | 7 (1.2) | 19 (3.2) | 11 (3.4) | 6 (1.8) |
| Any AE (excluding ISR), n (%) | 445 (75.3) | 510 (86.3) | 282 (86.2) | 254 (77.7) |
| Serious AEs (excluding ISR), n (%) | 26 (4.4) | 31 (5.2) | 11 (3.4) | 16 (4.9) |
| Grade 3–5 AEs (excluding ISR) maintenance phase | 35 (5.9) | 47 (8.0) | 20 (6.1) | 16 (4.9) |
AE adverse event, ATLAS Antiretroviral Therapy as Long-Acting Suppression, ATLAS-2M ATLAS every 2 months, CAB cabotegravir, FLAIR First Long-Acting Injectable Regimen, HIV-1 human immunodeficiency virus type 1, ISR injection-site reaction, Q4W every 4 weeks, Q8W every 8 weeks, RNA ribonucleic acid, RPV rilpivirine, SD standard deviation, SoC standard of care, LA Long-acting
aParticipants with prior CAB + RPV LA exposure were excluded
bAs per the FDA snapshot algorithm
cThese include discontinuations due to AEs and other reasons such as: lost to follow-up, protocol deviations, investigator decision, lack of efficacy etc.
dThese include participants with no virologic data at Week 48 who discontinued due to AEs