TABLE 1.
Summary of studies included in the analysis
| Study number | Study description | CAB dose and administration | HIV‐1‐infected | Number a of subjects | Number a of concentrations |
|---|---|---|---|---|---|
| Model‐building dataset | |||||
| 116585 | Oral relative bioavailability study | 30 mg (SST) PO SD | No | 18 (10 M, 8 F) | 238 |
| 117010 | Rifampin DDI study, period 1 only (without rifampin) | 30 mg (SST) PO SD | No | 15 (10 M, 5 F) | 194 |
| 117011 | OC DDI study | 30 mg (SST) PO QD × 11 days | No | 19 (19 F) | 186 |
| 117020 | Oral relative bioavailability study | 30 mg (SST) PO SD | No | 22 (13 M, 9 F) | 286 |
| 201741 | Oral relative bioavailability study | 30 mg (SST) PO SD | No | 37 (27 M, 10 F) | 712 |
| 201479 | Hepatic impairment study | 30 mg (SST) PO SD | No | 16 (12 M, 4 F) | 206 |
| 201480 | Renal impairment study | 30 mg (SST) PO SD | No | 16 (12 M, 4 F) | 202 |
| 205696 | Food effect on CAB PK, fasted period | 30 mg (SST) PO SD | No | 23 (16 M, 7 F) | 301 |
| 115428 | Phase 1 repeat dose escalation of CAB LA, oral lead‐in phase only | 30 mg PO QD x 14 days | No | 43 (27 M, 16 F) | 301 |
| 116815 | LA relative bioavailability study (200 nm particle size only) |
Oral: 30 mg QD to SS. LA: 400 mg SD. |
No | 21 (15 M, 6 F) | 225 |
| 116482 (LATTE) | Phase 2b dose‐ranging study in HIV‐infected subjects with two NRTIs, induction phase |
10 mg tablet PO QD × 24 wk 30 mg tablet PO QD × 24 wk 60 mg (2 × 30 mg) PO QD × 24 wk |
Yes |
175 10 mg (57 M, 3 F) 30 mg (54 M, 2 F) 60 mg (55 M, 4 F) |
1478 |
| 200056 (LATTE‐2) | Phase 2b treatment study in HIV‐infected subjects |
30 mg PO QD × 20 wk, then 800 mg IM, then: Arm 1: 800 mg IM, then 400 mg IM Q4W Arm 2: 800 mg IM, 600 mg IM at wk 4, then Q8W |
Yes |
274 (252 M, 22 F) |
5884 |
| 201103 (HPTN 077) | Phase 2a PrEP study of safety, tolerability and PK of CAB LA in HS |
30 mg PO QD × 4 wk, 1‐wk washout, then: Arm 1: 800 mg IM Q12W × 3 Arm 2: 600 mg IM at wk 5, wk 9, then Q8W × 3 |
No |
134 (45 M, 89 F) |
2246 |
| 201120 (ECLAIR) | Phase 2a PrEP enabling study of CAB LA in male HS at low risk of contracting HIV | 30 mg QD × 4 wk, 1‐wk washout, 800 mg IM Q12W × 3 | No | 94 (94 M) | 1324 |
| 201584 (FLAIR) | Phase 3 treatment study b | 30 mg PO QD × 4 wk, 600 mg IM, then 400 mg IM Q4W | Yes |
278 (217 M, 61 F) |
4781 |
| 201585 (ATLAS) | Phase 3 treatment study c | 30 mg PO QD × 4 wk, 600 mg IM, then 400 mg IM Q4W | Yes |
462 (307 M, 155 F) |
5362 |
| External validation dataset d | |||||
| 207966 (ATLAS‐2M) | Phase 3 treatment study c |
Arm 1: 30 mg PO QD × 4 wk, 600 mg IM, then 400 mg IM Q4W Arm 2: 30 mg PO QD × 4 wk, 600 mg IM, 600 mg IM at wk 4, then Q8W |
Yes |
647 (507 M, 140 F) |
5097 |
Abbreviations: CAB, cabotegravir; DDI, drug‐drug interaction; F, female; HIV‐1, human immunodeficiency virus type‐1; INI, integrase inhibitor; IM, intramuscular; LA, long‐acting; M, male; NNRTI, non‐nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; OC, oral contraceptives; PI, protease inhibitor; PK, pharmacokinetic(s); PO, oral; PrEP, pre‐exposure prophylaxis; QD, once daily; Q4W, every 4 weeks; Q8W, every 8 weeks; Q12W, every 12 weeks; SD, single dose; SS, steady state; SST, sodium salt tablet; wk, week.
Actual numbers of subjects and CAB plasma concentrations included in the analysis. All participants from the study were included in this analysis unless otherwise specified.
Antiretroviral‐naive subjects, switch from an INI single tablet regimen.
Virologically suppressed, treatment‐experienced subjects, switch current INI‐ NNRTI‐, or PI‐based antiretroviral regimen.
Only the subjects who were not included in the model‐building dataset are summarized in this table.