Table 1.
Virologic outcomes by Snapshot (ITT-E) and observed analyses and protocol-defined virologic failure through week 240
| Outcome, n (%) | Randomized cohort | Non-randomized cohort | ||||
|---|---|---|---|---|---|---|
| Week 96 | Week 192a | Week 240b | Week 96 | Week 192a | Week 240b | |
| Snapshot analysis, ITT-E population | ||||||
| Number of participants | 272 | 272 | 267 | 99 | 99 | 92 |
| HIV-1 RNA < 40 copies/mL | 164 (60) | 145 (53) | 120 (45) | 37 (37) | 32 (32) | 20 (22) |
| HIV-1 RNA ≥ 40 copies/mL | 80 (29) | 90 (33) | 89 (33) | 43 (43) | 43 (43) | 43 (47) |
| Data in window not below threshold | 32 (12) | 27 (10) | 20 (7) | 15 (15) | 5 (5) | 5 (5) |
| D/C for lack of efficacy | 9 (3) | 12 (4) | 14 (5) | 3 (3) | 6 (6) | 6 (7) |
| D/C for other reason while not below threshold | 17 (6) | 21 (8) | 24 (9) | 6 (6) | 10 (10) | 10 (11) |
| Change in background ART | 22 (8) | 30 (11) | 31 (12)c | 19 (19) | 22 (22) | 22 (24)d |
| No virologic data | 28 (10) | 37 (14) | 58 (22) | 19 (19) | 24 (24) | 29 (32) |
| D/C study due to adverse event or death | 15 (6) | 16 (6) | 17 (6) | 14 (14) | 18 (8) | 18 (20) |
| D/C study for other reasons | 8 (3) | 15 (6) | 19 (7) | 4 (4) | 4 (4) | 4 (4) |
| Missing data during window but on study | ||||||
| Not COVID-19 related | 5 (2) | 2 (< 1) | 3 (1) | 1 (1) | 0 | 2 (2) |
| COVID-19 relatede | – | 4 (1) | 19 (7) | – | 2 (2) | 5 (5) |
| Observed analysis | ||||||
| Number of participants | 214 | 195 | 164 | 66 | 50 | 35 |
| HIV-1 RNA < 40 copies/mL | 170 (79) | 156 (80) | 135 (82) | 39 (59) | 36 (72) | 23 (66) |
| Protocol-defined virologic failuref | 63 (23) | 75 (28) | 80 (29) | 49 (49) | 52 (53) | 53 (54) |
ART antiretroviral therapy, D/C discontinued, ITT-E intention-to-treat exposed
aWeek 192 was the last study time point that included all participants from the original ITT-E population (no participants had completed the study)
bAt Week 240, 12 participants had completed the study by transitioning to locally approved fostemsavir (the first fostemsavir approval was in the USA in July 2020)
cWeek 240 HIV-1 RNA was < 40 copies/mL for 17 of these 31 participants
dWeek 240 HIV-1 RNA was < 40 copies/mL for 4 of these 22 participants
eCOVID-19-related missing data were the result of missed visits, partial visits where only drug was dispensed, and late visits that were outside the analysis window
fProtocol-defined virologic failure was defined as the following: before Week 24, confirmed (or last available before discontinuation) HIV-1 RNA ≥ 400 copies/mL after confirmed suppression to < 400 copies/mL or confirmed > 1 log10 copies/mL increase in HIV-1 RNA above nadir where nadir is ≥ 40 copies/mL; at or after Week 24, confirmed (or last available before discontinuation) HIV-1 RNA ≥ 400 copies/mL