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

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 [12,13,14]		ATLAS-2M [15]
	SOC (n = 591)	CAB + RPV Q4W (n = 591)	CAB + RPV Q4W^a (n = 327)	CAB + RPV Q8W^a (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 48^c, 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

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