TABLE 2.

Key laboratory results (CAB arm, group 1)^a

Case ID	Subtype	No. of injections	No. of late injections	Time since last injection (days)	VL (copies/mL) at 1st positive visit	[CAB] (μg/mL) at 1st positive visit	DX delay	Time to site detection (days)	Drug administration after infection	Ag/Ab lab test result at 1st positive visit	Confirmatory Ab test result at 1st positive visit	Major INSTI RAM at 1st positive visit	Major INSTI RAM at any visitb	TDF-FTC administration	[TFV] (ng/mL) at 1st positive visit
A1	B	0	0	NA	4,010	BLQ	Yes	28	Yes	NR	NA	No	No	No
A2	C	1	0	NA	50,080	BLQ	Yes	60	Yes	NR	NA	No	Yes	No
A3	B	2	0	NA	1,360	BLQ	Yes	72	Yes	NR	NA	No	No	No
A4	B	2	0	NA	44,180	BLQ	Yes	63	Yes	R	NEG	No	No	No
C1	B	2	0	NA	120	6,301	Yes	47	Yes	NR	NA	No	Yes	No
C2	BF	0	0	NA	494	BLQ	Yes	185	No	NR	NA	No	No	No
C3	B	1	0	NA	SCA, 15.3	10.690	Yes	35	Yes	NR	NA	No	Yes	No
D1	Likely B	10	1c	56	130	1.613	Yes	112	Yes	NR	NA	Yes	Yes	No
D2	Likely B	6	0	14	SCA, 6.1	1.405	Yes	98	Yes	NR	NA	Failed testing	Yes	No
D3	BF	5	0	56	860	1.504	Yes	117	Yes	NR	NA	No	Yes	No
D4	C	4	0	13	<40	2.017	Yes	45	Yes	NR	NA	Failed testing	Yes	No
D5	F	5	0	21	59	1.906	Yes	42	No	NR	NA	Yes	Yes	No
D6	AE	15	0	53	2,020	1.824	Yes	59	Yes	NR	NA	No	Yes	No
DX1	B	7	3	87	1,212,660	0.495	No		Yes	R	IND	No	NA (ART)	No
DX2	BF	10	1	168	73,380	BLQ	No		Yes	R	IND	No	No	No
DX3	B	6	1	169	48,030	0.041	No		No	R	POS	No	NA (ART)	No
BR1	BC	9	1d	422	450	BLQ	Yes	81	Yes	NR	NA	No	Yes	No
BR2	B	20	2d	425	1,620	BLQ	No		Yes	NR	NA	No	No	Yes	102

^aKey laboratory results for cases in the cabotegravir (CAB) arm of HPTN 083 where the participant received CAB within 6 months of the first HIV-positive visit (group 1). The HIV subtype was determined by phylogenetic analysis of HIV sequences; if HIV sequences were not available, the likely subtype was assigned based on the predominant subtype in the region. The total number of injections received and the number of delayed injections (late, >2 weeks after the planned injection [>44 days after the 1st injection or >70 days after subsequent injections]) are shown. The number of days between the last injection and the first HIV-positive visit is shown. Some participants switched from CAB PrEP to TDF-FTC PrEP; for those participants, the concentration of tenofovir at the first HIV-positive visit is shown. Ab, antibody; Ag, antigen; ART, antiretroviral therapy; BLQ, below the limit of quantification; [CAB], CAB concentration (micrograms per milliliter); Case ID, case identifier; DX delay, delayed detection of HIV infection at the study site; FTC, emtricitabine; IND, indeterminate; INSTI, integrase strand transfer inhibitor; NA, not applicable (testing not indicated); NEG, negative; NR, nonreactive; POS, positive; RAM, resistance-associated mutation; R, reactive; TDF, tenofovir disoproxil fumarate; [TFV], tenofovir concentration (nanograms per milliliter); VL, viral load (HIV RNA copies per milliliter).

^bThe INSTI RAMs detected in each case are shown in File S5 in the supplemental material.

^cThis case was classified as a D case in previous publications. This participant had one delayed injection (the 6th of 9 injections was 75 days after the previous injection) and would be classified as a DX case under the updated classification system used in this report.

^dIn both of the BR cases, CAB injections were restarted before the site was aware that the participants had HIV infection. For case BR1, CAB-LA was restarted 422 days after a series of 7 on-time injections; the 8th injection was given 3 days after the first HIV-positive visit. For case BR2, CAB-LA was restarted in the open-label extension (OLE) 425 days after the participant completed all 19 scheduled injections in the main HPTN 083 study. In this case, the 20th injection was given at the first HIV-positive visit; one of the 19 previous injections was delayed (time interval, 75 days). Note that this report does not include participants who acquired HIV infection after the first OLE visit.