Table 3.
Summary of Adverse Events Through Week 96
| Adverse Events | Total (N = 45) n (%) | 95% CI |
|---|---|---|
| ≥1 AEs | 45 (100) | (92.1, 100) |
| ≥1 drug-related AEsa | 4 (8.9) | (2.5, 21.2) |
| Permanent discontinuation due to an AEb | 1 (2.2) | (0.1, 11.8) |
| Permanent discontinuation due to a drug-related AE | 0 | (0, 7.9) |
| ≥1 serious AEsc | 2 (4.4) | (0.5, 15.1) |
| ≥1 drug-related serious AEs | 0 | (0, 7.9) |
| Deaths | 0 | (0, 7.9) |
| ≥Grade 3 AEsd | 11 (24.4) | (12.9, 39.5) |
| ≥Grade 3 drug-related AEs | 0 | (0, 7.9) |
| Most common AEs (>5% incidence overall)e | ||
| Increase serum creatinine | 5 (11.1) | |
| Decrease estimated glomerular filtration rate | 4 (8.9) |
Abbreviations: AE, adverse events; CI, confident interval; SD, standard deviation.
aA treatment-naïve participant had grade 1 dizziness, resolved without discontinuation.
bA participant had grade 4 increase ALT and active hepatitis C infection.
cOne had grade 3 gastroenteritis and grade 2 lip injury, another had grade 3 scrotal abscess.
dGrade ≥ 3 AEs included diarrhea (n = 1), gastroenteritis (n = 1), scrotal abscess (n = 1), increased ALT (n = 2), increased AST (n = 1), increased serum creatinine (n = 5), increased blood pressure (n = 2), decreased eGFR (n = 4), and hypertension (n = 2). Some participants had > 1 events.
eAll occurred in virologic-suppressed group.