Table 2.
Adverse Event Summary
| Cumulative Week 152 Data Analysis,a n (%) | Participants With Incident AEs Between Week 96 and Week 152 Data Analyses, n (%) | |||
|---|---|---|---|---|
| Q8W (n = 522) | Q4W (n = 523) | Q8W (n = 522) | Q4W (n = 523) | |
| Any AE | 503 (96) | 508 (97) | 15 (3) | 9 (2) |
| Drug-related AEs | 427 (82) | 427 (82) | 12 (2) | 14 (3) |
| Excluding ISRs | 142 (27) | 167 (32) | 20 (4) | 21 (4) |
| Any grade 2 to 5 AE | 367 (70) | 377 (72) | 42 (8) | 44 (8) |
| Drug-related | 195 (37) | 210 (40) | 17 (3) | 23 (4) |
| Leading to withdrawal | 23 (4) | 25 (5) | 5 (1) | 6 (1) |
| Drug-related | 12 (2) | 18 (3) | 0 | 3 (<1) |
| Any SAE | 49 (9) | 44 (8) | 16 (3) | 16 (3) |
| Drug-relatedb | 4 (<1) | 3 (<1) | 0 | 0 |
| Fatal SAEs | 3 (<1) | 3 (<1)c | 2 (<1)d | 2 (<1)e |
| Drug-related | 0 | 0 | 0 | 0 |
| Common non-ISR AEs (≥10% in either treatment group) | ||||
| Nasopharyngitis | 97 (19) | 105 (20) | 7 (1) | 9 (2) |
| Upper respiratory tract infection | 80 (15) | 98 (19) | 8 (2) | 4 (<1) |
| Headache | 66 (13) | 82 (16) | 14 (3) | 35 (7) |
| Back pain | 64 (12) | 77 (15) | 19 (4) | 29 (6) |
| Arthralgia | 62 (12) | 65 (12) | 31 (6) | 29 (6) |
| Diarrhea | 56 (11) | 66 (13) | 12 (2) | 13 (2) |
| Pyrexia | 48 (9) | 73 (14) | 10 (2) | 26 (5) |
| Cough | 37 (7) | 59 (11) | 4 (<1) | 17 (3) |
| Common non-ISR drug-related AEs (≥3% in either treatment group) | ||||
| Pyrexia | 23 (4) | 33 (6) | 3 (<1) | 8 (2) |
| Fatigue | 11 (2) | 23 (4) | 0 | 2 (<1) |
Abbreviations: AE, adverse event; ISR, injection-site reaction; Q4W, every 4 weeks; Q8W, every 8 weeks; RPV, rilpivirine; SAE, serious adverse event.
Drug-related SAEs (per investigator assessment) were injection-site abscess (n = 1), osteonecrosis (n = 1), presyncope (n = 1), and acute pancreatitis and sepsis (n = 1) in the Q8W arm, and hypersensitivity and suspected (partial) intravenous administration of RPV (n = 1), drug hypersensitivity and suspected postinjection reaction (n = 1), and myocardial infarction (n = 1) in the Q4W group.
An additional participant died 2 months after completing the long-term follow-up. This was due to respiratory failure secondary to cardiac arrest.
Suicide (n = 1) and pancreatic cancer (n = 1).
Cardiac arrest (n = 1) and chronic obstructive pulmonary disease and chronic renal failure (n = 1).