Table 2.
Adverse Events Overall and Stratified by Study Arm at 192 Weeksa
| Overall (n (%)) | Current Therapy (n (%)) | Monotherapy (n (%)) | P value | Switchers (n (%)) | |
|---|---|---|---|---|---|
| n | 101 | 33 | 68 | 18 | |
| Any AE | 99 (98.0) | 32 (97.0) | 67 (98.5) | 1 | 17 (94.4) |
| Study drug-related AE | 24 (23.8) | 9 (27.3) | 15 (22.1) | .743 | 1 (5.6) |
| Any SAE | 27 (26.7) | 10 (30.3) | 17 (25.0) | .745 | 1 (5.6) |
| Antiretroviral therapy switch due to AE | 6 (5.9) | 5 (15.2) | 1 (1.5) | .023 | 0 (0.0) |
| Intensityb | |||||
| Mild | 98 (97.0) | 31 (93.9) | 67 (98.5) | .516 | 17 (94.4) |
| Moderate | 65 (64.4) | 22 (66.7) | 43 (63.2) | .907 | 4 (22.2) |
| Severe | 8 (7.9) | 3 (9.1) | 5 (7.4) | 1 | 0 (0.0) |
| Laboratory AE | 57 (56.4) | 16 (48.5) | 41 (60.3) | 0.364 | 7 (38.9) |
| Laboratory AE, intensityb | |||||
| Mild | 52 (51.5) | 14 (42.4) | 38 (55.9) | .29 | 6 (33.3) |
| Moderate | 5 (5.0) | 2 (6.1) | 3 (4.4) | 1 | 1 (5.6) |
| Arthralgia | 27 (26.7) | 8 (24.2) | 19 (27.9) | .877 | 0 (0.0) |
| Back pain | 28 (27.7) | 8 (24.2) | 20 (29.4) | .759 | 2 (11.1) |
| Depression | 13 (12.9) | 6 (18.2) | 7 (10.3) | .428 | 0 (0.0) |
| Diarrhea | 11 (10.9) | 5 (15.2) | 6 (8.8) | .537 | 0 (0.0) |
| Elective operation or intervention | 8 (7.9) | 4 (12.1) | 4 (5.9) | .486 | 0 (0.0) |
| Fatigue | 7 (6.9) | 2 (6.1) | 5 (7.4) | 1 | 0 (0.0) |
| Gastritis/GERD | 15 (14.9) | 6 (18.2) | 9 (13.2) | .721 | 1 (5.6) |
| Headache | 14 (13.9) | 5 (15.2) | 9 (13.2) | 1 | 2 (11.1) |
| Headache after lumbar puncture | 6 (5.9) | 3 (9.1) | 3 (4.4) | .628 | 0 (0.0) |
| Neoplasia | 4 (4.0) | 2 (6.1) | 2 (2.9) | .834 | 1 (5.6) |
| Psychosocial stress | 7 (6.9) | 2 (6.1) | 5 (7.4) | 1 | 0 (0.0) |
| Sexually transmitted infection | 46 (45.5) | 13 (39.4) | 33 (48.5) | .515 | 8 (44.4) |
| Skin rash | 24 (23.8) | 9 (27.3) | 15 (22.1) | .743 | 2 (11.1) |
| Sleeping disorder | 6 (5.9) | 1 (3.0) | 5 (7.4) | .679 | 0 (0.0) |
| Trauma | 22 (21.8) | 7 (21.2) | 15 (22.1) | 1 | 3 (16.7) |
| Viral URTI | 59 (58.4) | 17 (51.5) | 42 (61.8) | .444 | 8 (44.4) |
| Other infection (mild) | 35 (34.7) | 11 (33.3) | 24 (35.3) | 1 | 3 (16.7) |
| Other infection (moderate/severe) | 43 (42.6) | 12 (36.4) | 31 (45.6) | .506 | 4 (22.2) |
| Vitamin deficiency | 13 (12.9) | 4 (12.1) | 9 (13.2) | 1 | 3 (16.7) |
| Other | 72 (71.3) | 21 (63.6) | 51 (75.0) | .342 | 9 (50.0) |
Abbreviations: AE, adverse event; GERD, gastro-esophageal reflux disease; SAE, serious adverse event.
Data up to week 48 previously reported as part of the EARLY-SIMPLFIED interim analysis [12].
Mild indicates causing minimal symptoms and self-limiting, moderate indicates greater than minimal symptoms or requiring physician intervention but not meeting the criteria for SAE, severe indicates meeting the standard criteria for SAE.