TABLE 2.
Original Definition | Alternative Definition 1 | Alternative Definition 2 | Alternative Definition 3 | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Criteria | (1) The most recent viral load (VL) in the 18-month follow-up period after randomization is <200 copies/mL; and (2) the VL immediately before, but at least three months apart from, the most recent VL is <200 copies/mL; and (3) all VLs between time (1) and time (2) are <200 copies/mL |
Original definition plus the last VL occurring at least 6 months postrandomization |
Original definition but VLs restricted to 6–18 months† |
All VLs postrandomization are <200 copies/mL including if only 1 VL was recorded |
||||||||
Site | Standard of Care N (%) |
Intervention N (%) |
P | Standard of Care N (%) |
Intervention N (%) |
P | Standard of Care N (%) |
Intervention N (%) |
P | Standard of Care N (%) |
Intervention N (%) |
P |
All sites | 396/935 (42.3%) |
415/958 (43.3%) |
0.67 | 391/935 (41.8%) |
411/958 (42.9%) |
0.63 | 303/935 (32.4%) |
301/958 (31.42%) |
0.65 | 407/935 (43.5%) |
415/958 (43.3%) |
0.93 |
CT | 145/322 (45.0%) |
155/332 (46.7%) |
0.67 | 144/322 (44.7%) |
154/332 (46.4%) |
0.67 | 113/322 (35.1%) |
117/332 (35.2%) |
0.97 | 148/322 (46.0%) |
159/332 (47.9%) |
0.62 |
MA | 139/313 (44.4%) |
129/317 (40.7%) |
0.35 | 136/313 (44.4%) |
129/317 (40.7%) |
0.48 | 101/313 (32.3%) |
88/317 (27.8%) |
0.22 | 147/313 (47.0%) |
137/317 (43.2%) |
0.35 |
PHL | 112/300 (37.3%) |
131/309 (42.4%) |
0.20 | 111/300 (37.0%) |
128/309 (41.4%) |
0.26 | 89/300 (29.7%) |
96/309 (31.1%) |
0.71 | 112/300 (37.3%) |
119/309 (38.5%) |
0.76 |
An intent-to-treat approach was used, meaning all participants randomized in this study were included in the analysis regardless of disposition or acceptance of the intervention and missing VLs were presumed as failure.
The number of individuals achieving durable viral suppression in Alternative Definition 2 are lower for each cell compared with the original definition due primarily to having <2 VLs available during the time frame of 6–18 months.