TABLE 3.
Key laboratory results (CAB arm, group 2)a
| Case IDb | 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 visit | TDF-FTC administration | [TFV] (ng/mL) at 1st positive visit |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B1 | B | 2 | 1 | 849 | 65,530 | 0.065 | No | No | R | POS | No | NA (ART) | Yes | BLQ | |
| B2 | AB | 0 | 0 | NA | 53,220 | BLQ | No | No | R | POS | No | NA (ART) | No | ||
| B3 | AE | 4 | 0 | 217 | 50,440 | 0.100 | No | No | R | IND | No | NA (ART) | No | ||
| B5 | B | 0 | 0 | NA | 2,559 | BLQ | No | No | R | POS | No | NA (ART) | No | ||
| B6 | B | 0 | 0 | NA | 28,040 | BLQ | No | No | R | POS | No | No | No | ||
| B7 | B | 0 | 0 | NA | 31,020 | BLQ | No | No | R | POS | No | No | No | ||
| B8 | B | 3 | 0 | 429 | 631,510 | BLQ | No | No | R | POS | No | NA | No | ||
| B9 | B | 6 | 0 | 315 | 1,387,280 | BLQ | No | No | R | POS | No | No | No | ||
| B10 | AE | 9 | 1 | 210 | 154,820 | 0.067 | No | No | R | NEG | No | No | No | ||
| B11 | B | 5 | 2 | 336 | 43,720 | BLQ | No | No | R | POS | No | No | No | ||
| B13 | B | 6 | 2 | 227 | 21,290 | BLQ | No | No | R | POS | No | NA (ART) | Yes | 109 | |
| B14 | B | 19 | 0 | 234 | 139,970 | BLQ | No | No | R | POS | No | No | Yes | BLQ | |
| B15 | B | 19 | 0 | 292 | SCA, 7.4 | 0.110 | Yes | 85 | Yes, TDF | NR | NA | Failed testing | No | Yes | BLQ |
| B16 | B | 19 | 1 | 324 | 167,840 | BLQ | No | Yes, TDF | R | NEG | No | No | Yes | BLQ |
Key laboratory results for cases in the cabotegravir (CAB) arm of HPTN 083 where the participant had no CAB administration within 6 months of the first HIV-positive visit (group 2, no recent CAB administration). The HIV subtype was determined by phylogenetic analysis of HIV sequences. 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; 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; 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; [TFV], tenofovir concentration (nanograms per milliliter); VL, viral load (HIV RNA copies per milliliter).
Two B cases are not included in group 2 (B4 and B12) since the first HIV-positive visit in these cases occurred after the participants started antiretroviral therapy (ART). Case B4 started ART with tenofovir alafenamide, emtricitabine (FTC), and bictegravir 10 days prior to the first HIV-positive visit where a sample was available for testing. HIV genotyping failed at that visit, and no resistance results are available. Case B12 started ART with tenofovir disoproxil fumarate (TDF), emtricitabine, and efavirenz 74 days prior to the first HIV-positive visit where a sample was available for testing. No major resistance mutations were detected at that visit.