| Abstract P168 – Table 1. Neuropsychiatric AEs through week 48 across the CAB + RPV LA phase III/IIIb programme. | ||
|---|---|---|
| CAB + RPV LA | Daily oral therapya | |
| Q8W + Q4W pooled | ||
| (N = 1245) | (N = 591) | |
| Baseline characteristics | ||
| Median age (range), years | 39 (19 to 83) | 38 (18 to 82) |
| Female sex at birth, n (%) | 310 (25) | 168 (28) |
| Race, n (%) | ||
| White | 924 (74) | 408 (69) |
| Black or African American | 211 (17) | 133 (23) |
| Other races | 110 (9) | 48 (8) |
| Safety summary | ||
| Neuropsychiatric AEs overall, n (%) | ||
| Total | 319 (26) | 104 (18) |
| Drug related | 111 (9) | 14 (2) |
| Grade 3b | 4 (<1) | 1 (<1) |
| Leading to withdrawal | 10 (<1) | 3 (<1) |
| Drug‐relatedc neuropsychiatric disorders occurring in ≥5 participants in either arm, n (% of participants)d | ||
| Nervous system disorders | ||
| Headache | 41 (3) | 4 (<1) |
| Median duration, days (IQR)e | 4 (2 to 8) | 75 (45 to 104) |
| Dizziness | 23 (2) | 1 (<1) |
| Median duration, days (IQR) | 2 (1 to 4) | Event not resolved |
| Psychiatric disorders | ||
| Insomnia | 15 (1) | 1 (<1) |
| Median duration, days (IQR)f | 14 (4 to 57) | 112 (112 to 112) |
| Abnormal dreams | 12 (<1) | 2 (<1) |
| Median duration, days (IQR) | 37 (7 to 58) | 47 (41 to 52) |
| Anxiety disordersg | 11 (<1) | 3 (<1) |
| Median duration, days (IQR) | 53 (6 to 74) | 27 (3 to 73) |
| Depressive disordersh | 10 (<1) | 1 (<1) |
| Median duration, days (IQR) | 28 (9 to 94) | 3 (3 to 3) |
| Suicidal ideation/behaviouri | 1 (<1) | 1 (<1) |
| Median duration, days | 4 | 3 |
| Other (of potential interest) | ||
| Seizures/seizure‐like events | 0 | 0 |
AE, adverse event; CAB, cabotegravir; IQR, interquartile range; LA, long‐acting; Q4W, every 4 weeks; Q8W, every 8 weeks; RPV, rilpivirine.
aParticipants receiving integrase strand transfer inhibitors, n = 382 (FLAIR, n = 283; ATLAS, n = 99);
bthere were no grade 4 or 5 neuropsychiatric AEs;
cper investigator assessment;
doccurred in ≥5 participants except for the suicidal ideation/behaviour category (depression suicidal, n = 1 [CAB + RPV LA]; suicidal ideation, n = 1 [daily oral therapy]);
emedian duration based on CAB + RPV LA n = 39 and daily oral therapy n = 2;
fmedian duration based on CAB + RPV LA n = 13;
gincludes the following recorded terms: anxiety, anxiety disorder, nervousness, and panic attack;
hmedian duration based on CAB + RPV LA n = 8. Includes the following recorded terms: depression, depressed mood, and adjustment disorder with depressed mood. Median duration based on CAB + RPV LA n = 8;
iincludes the following terms: depression suicidal and suicidal ideation. Suicidal ideation/behaviour occurred in <5 participants but is included as it may be of potential interest.