Table 2. Grade 2 and higher AEs experienced by at least 5% of participants during the injection phase.
| AE | CAB LA (n = 134) | PBO (n = 43) | p-Value* | |||
|---|---|---|---|---|---|---|
| n (%) | 95% CI | n (%) | 95% CI | |||
| AE ≥ Grade 2 | 122 (91.0%) | 85.0%, 94.8% | 38 (88.4%) | 75.5%, 94.9% | 0.565 | |
| Serious adverse event | 4 (3.0%) | 1.2%, 7.4% | 2 (4.7%) | 1.3%, 15.5% | 0.634 | |
| Creatinine renal clearance decreased† | 63 (47.0%) | 38.8%, 55.4% | 20 (46.5%) | 32.5%, 61.1% | 1.000 | |
| Injection site reaction‡ | 51 (38.1%) | 30.3%, 46.5% | 1 (2.3%) | 0.4%, 12.1% | <0.001 | |
| Musculoskeletal discomfort | 34 (25.4%) | 18.8%, 33.4% | 6 (14.0%) | 6.6%, 27.3% | 0.145 | |
| Upper respiratory infection | 31 (23.1%) | 16.8%, 31.0% | 10 (23.3%) | 13.0%, 37.7% | 1.000 | |
| Headache | 22 (16.4%) | 11.7%, 24.4% | 4 (9.3%) | 3.7%, 21.6% | 0.326 | |
| Hypoglycemia | 15 (11.2%) | 6.9%, 17.6% | 3 (7.0%) | 2.4%, 18.6% | 0.568 | |
| Influenza | 14 (10.4%) | 6.3%, 16.8% | 3 (7.0%) | 2.4%, 18.6% | 0.766 | |
| Blood creatinine increased | 13 (9.7%) | 5.8%, 15.9% | 3 (7.0%) | 2.4%, 18.6% | 0.764 | |
| Nasopharyngitis | 14 (10.4%) | 6.3%, 16.8% | 2 (4.7%) | 1.3%, 15.5% | 0.364 | |
| Lipase increased | 10 (7.5%) | 4.1%, 13.2% | 4 (9.3%) | 3.7%, 21.6% | 0.747 | |
| Conjunctivitis | 11 (8.2%) | 4.6%, 14.1% | 1 (2.3%) | 0.4%, 12.1% | 0.298 | |
| Gastroenteritis | 10 (7.5%) | 4.1%, 13.2% | 2 (4.7%) | 1.3%, 15.5% | 0.733 | |
| Urinary tract infection | 11 (8.2%) | 4.6%, 14.1% | 1 (2.3%) | 0.4%, 12.1% | 0.298 | |
| Blood creatine phosphokinase increased | 6 (4.5%) | 2.1%, 9.4% | 5 (12%) | 5.1%, 24.5% | 0.139 | |
| Rash | 9 (6.7%) | 4.1%, 13.2% | 1 (2.3%) | 0.4%, 12.1% | 0.455 | |
| Dermatitis | 8 (6.0%) | 3.1%, 11.3% | 2 (4.7%) | 1.3%, 15.5% | 1.000 | |
| Weight decreased | 6 (4.5%) | 2.1%, 9.4% | 3 (7.0%) | 2.4%, 18.6% | 0.455 | |
| Genital candidiasis | 7 (5.2%) | 2.6%, 10.4% | 1 (2.3%) | 0.4%, 12.1% | 0.682 | |
| Sinusitis | 7 (5.2%) | 2.6%, 10.4% | 1 (2.3%) | 0.4%, 12.1% | 0.682 | |
| Depression | 0 (0.0%) | 0.0%, 2.8% | 3 (7.0%) | 2.4%, 18.6% | 0.014 | |
*p-Value for comparing the cabotegravir and PBO arms.
†Grade 2 AEs for creatinine clearance are determined by a result of <90 to 60 ml/min or a 10% to <30% decrease from baseline. Grade 3 AEs for creatinine clearance are determined by a result of <60 to 30 ml/min or a 30% to <50% decrease from baseline. Of these participants, 42 (51%) had a decrease from baseline but maintained a creatinine clearance ≥90 ml/min during the entire injection phase; 26 (31%) experienced a treatment-emergent decline in creatinine clearance to <90 ml/min. Creatinine clearance returned to >90 ml/min during the injection phase for 20 (80%) of the 26 participants without interruption of study products. Fourteen participants began the study with a Grade 2 creatinine clearance (<90 mm/min), which improved to >90 ml/min on study products, and then returned to <90 ml/min creatinine clearance. One participant in the PBO arm experienced a transient decline in creatinine clearance from 70 ml/min to 57 ml/min.
‡Injection site pain in 47/52 (90%).
CAB LA, long-acting cabotegravir; PBO, placebo.