Table 2.
Safety and adverse events (AEs) in part 1 (all patients as treated; initial treatment phase through follow-up week 4)
| AEs | 50 mg EBR + 50 mg GZR (n = 31) | 50 mg EBR + 100 mg GZR (n = 31) |
|---|---|---|
| ≥1 AEa | 21 (67.7%) | 23 (74.2%) |
| Nasopharyngitis | 7 (22.6%) | 10 (32.3%) |
| Headache | 4 (12.9%) | 3 (9.7%) |
| Pyrexia | 3 (9.7%) | 1 (3.2%) |
| Dry eye | 2 (6.5%) | 0 (0%) |
| Upper abdominal pain | 2 (6.5%) | 1 (3.2%) |
| Diarrhea | 2 (6.5%) | 1 (3.2%) |
| Accidental overdose | 1 (3.2%) | 2 (6.5%) |
| Drug-related AE | 10 (32.3%) | 9 (29.0%) |
| SAEb | 1 (3.2%) | 1 (3.2%) |
| Discontinuation because of AEs | 0 (0%) | 0 (0%) |
| Deaths | 0 (0%) | 0 (0%) |
| ALT | ||
| 1.1–2.5 times baseline level | 0 (0%) | 0 (0%) |
| >2.5–5.0 times baseline level | 1 (3.2%) | 0 (0%) |
| >5.0 times baseline level | 0 (0%) | 0 (0%) |
| AST | ||
| 1.1–2.5 times baseline level | 1 (3.2%) | 1 (3.2%) |
| >2.5–5.0 times baseline level | 0 (0%) | 0 (0%) |
| >5.0 times baseline level | 0 (0%) | 0 (0%) |
| Total bilirubin | ||
| >2.5–5.0 times baseline level | 0 (0%) | 0 (0%) |
| >5.0–10.0 times baseline level | 0 (0%) | 0 (0%) |
| >10.0 times baseline level | 0 (0%) | 0 (0%) |
| Alkaline phosphatase | ||
| 1.1–2.5 times baseline level | 4 (12.9%) | 3 (9.7%) |
| >2.5–5.0 times baseline level | 0 (0%) | 0 (0%) |
| >5.0 times baseline level | 0 (0%) | 0 (0%) |
ALT alanine aminotransferase, AST aspartate aminotransferase, EBR elbasvir, GZR grazoprevir, SAE serious AE
aIncidence greater than 5% in one or more treatment groups
bSAEs of acute coronary syndrome in one patient receiving GZR at a dose of 50 mg and hematochezia with large intestine polyp in one patient receiving GZR at a dose of 100 mg. One patient receiving GZR at a dose of 50 mg reported an SAE of adenocarcinoma of the colon outside the safety observation window (more than 4 months after the final dose)