Table 5.
Efficacy and safety of elbasvir/grazoprevir (EBR/GZR) ± ribavirin (RBV) in key clinical trials
| Clinical trial | Population | Regimen | Duration (weeks) | Gt | Overall SVR (%) | Gt 1a SVR (%) | Gt 1b SVR (%) | Gt 4 SVR (%) | Severe AEs (%) |
|---|---|---|---|---|---|---|---|---|---|
| C-SURFER30 | Advanced CKD | EBR/GZR | 12 | 1 | 94 | 97 | 92 | – | 15.6 |
| C-EDGE TN17 | TN ± cirrhosis | EBR/GZR | 12 | 1, 4, 6 | 95 | 92 | 99 | 100 | 3.0 |
| C-EDGE COINFECTION18 | HIV, TN ± cirrhosis | EBR/GZR | 12 | 1, 4, 6 | 96 | 97 | 96 | 96 | 0.9 |
| C-EDGE TE24 | P/R ± cirrhosis ± HIV | EBR/GZR ± RBV | 12 or 16 | 1, 4, 6 | 95 | 95 | 99 | 89 | 3.3 |
| C-WORTHY33 | ± HIV | EBR/GZR ± RBV | 8 or 12 | 1 | 97 | 94 | 93 | – | 1.4 |
| C-SALVAGE22 | PI + P/R ± cirrhosis | EBR/GZR + RBV | 12 | 1 | 96 | 93 | 98 | – | 5.1 |
| Japanese20 | No cirrhosis | EBR/GZR | 12 | 1 | 97 | 100 | 96 | – | 0 |
Abbreviations: AEs, adverse events; CKD, chronic kidney disease; Gt, genotype; PI, protease inhibitor; P/R, PEGylated interferon and ribavirin; SVR, sustained virological response; TE, treatment-experienced; TN, treatment-naïve.