Table 2.
Adverse event overview.
| Parameter, n (%) | IM CAB+RPV LA Q2M arm n = 90 | Oral DTG/RPV QD arm n = 7 |
| Any AE | 86 (96) | 3 (43) |
| Grade ≥3 AE | 9 (10) | 0 |
| Common AEs (≥5% in either arm, excluding ISRs), n (%) | ||
| Nasopharyngitis | 10 (11) | 0 |
| Upper respiratory tract infection | 10 (11) | 0 |
| Diarrhea | 9 (10) | 0 |
| Pyrexia | 9 (10) | 0 |
| Headache | 6 (7) | 1 (14) |
| Fatigue | 6 (7) | 0 |
| Syphilis | 6 (7) | 0 |
| Cough | 5 (6) | 0 |
| Hemorrhoids | 5 (6) | 0 |
| Nausea | 5 (6) | 0 |
| Abdominal pain | 2 (2) | 1 (14) |
| Muscle strain | 1 (1) | 1 (14) |
| Erythema | 0 | 1 (14) |
| Hepatic steatosis | 0 | 1 (14) |
| Drug-related AEs | 65 (72) | 1 (14) |
| Grade ≥3 AE | 0 | 0 |
| Common drug-related AEs (≥3% in either arm, excluding ISRs), n (%) | ||
| Pyrexia | 7 (8) | 0 |
| Fatigue | 4 (4) | 0 |
| Pain | 3 (3) | 0 |
| Headache | 2 (2) | 1 (14) |
| AEs leading to withdrawal | 1 (1)a | 0 |
| Drug-related AEs leading to withdrawal | 1 (1)a | 0 |
| Any SAE | 5 (6)b | 0 |
| Drug-related SAEs | 1 (1)c | 0 |
a
Drug-related AE of depression.
b
SAEs included cholecystitis acute (n = 1), cholelithiasis (n = 1), anal abscess (n = 1), orchitis (n = 1), urinary tract infection bacterial (n = 1), proctitis (n = 1), and injection site extravasation (n = 1). Participants could have experienced >1 SAE.
c
Drug-related SAE of injection site extravasation.
Table 2 was presented previously at IDWeek; October 21–25, 2020; Virtual; Oral.
AE, adverse event; CAB, cabotegravir; DTG, dolutegravir; IM, intramuscular; ISR, injection site reaction; LA, long-acting; QD, once daily; Q2M, every 2 months; RPV, rilpivirine; SAE, serious adverse event.