Table 3.
Summary of pivotal clinical trials
| Patient population | Study name/design | N | Treatment arm(s) | SVR (%) |
|---|---|---|---|---|
| Treatment-naïve non-cirrhotic | SAPPHIRE-I11 randomized, double-blind, placebo-controlled | 631 | Arm 1: PrOD + RBV, 12 weeks Arm 2: Placebo |
SVR12 by GT (Arm 1) GT 1a – 307/322 (95%) GT 1b – 148/151 (98%) |
| PEARL-III (GT 1b)12 randomized, double-blind | 419 | Arm 1: PrOD + RBV, 12 weeks Arm 2: PrOD, 12 weeks |
SVR12 Arm 1 – 209/210 (100%) Arm 2 – 209/209 (100%) |
|
| PEARL-IV (GT 1a)12 randomized, double-blind | 305 | Arm 1: PrOD + RBV, 12 weeks Arm 2: PrOD, 12 weeks |
SVR12 Arm 1 – 97/100 (97%) Arm 2 – 185/205 (90%) |
|
| Treatment-experienced non-cirrhotic | SAPPHIRE-II (GT 1b)13 randomized, double-blind, placebo-controlled | 394 | Arm 1: PrOD + RBV, 12 weeks Arm 2: Placebo |
SVR12 by GT (Arm 1) GT 1a – 166/173 (96%) GT 1b – 119/123 (97%) |
| PEARL-II14 randomized, open-label | 186 | Arm 1: PrOD + RBV, 12 weeks; Arm 2: PrOD, 12 weeks |
SVR12 Arm 1 – 85/88 (97%); Arm 2 – 91/91 (100%) |
|
| Compensated cirrhosis treatment-naïve or experienced | TURQUOISE-II15 randomized, open-label | 380 | Arm 1: PrOD + RBV, 12 weeks Arm 2: PrOD + RBV, 24 weeks |
Overall SVR12 Arm 1 – 191/208 (91.8%) Arm 2 – 165/172 (95.9%) SVR12 by GT |
| GT 1a Arm 1 – 124/140 (88.6%) Arm 2 – 114/121 (94.2%) |
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| GT 1b Arm 1 – 67/68 (98.5%) Arm 2 – 51/51 (100%) |
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| TURQUOISE-III16 single arm open-label | 60 | PrOD, 12 weeks | SVR12 60/60 (100%) |
|
| HIV coinfection | TURQUOISE-I17 randomized, open-label | 63 | Arm 1: PrOD + RBV, 12 weeks Arm 2: PrOD + RBV, 24 weeks |
SVR12 Arm 1 – 29/31 (94%) Arm 2 – 29/32 (91%) |
| Post-liver transplant | CORAL I18 open label single arm | 34 | PrOD + RBV, 24 weeks | SVR24 33/34 (97%) |
| Genotype 4 non-cirrhotic treatment-naïve or experienced | PEARL-I19 randomized, open-label | 320 | TN Arm 1: PrO + RBV, 12 weeks Arm 2: PrO, 12 weeks |
Arm 1 – 42/42 (100%) Arm 2 – 40/44 (91%) |
| TE PrO + RBV, 12 weeks |
49/49 (100%) |
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| Severe renal impairment | RUBY-I (GT 1a)20,21 | 40 | PrOD + RBV | Results pending as ongoing study |
Abbreviations: GT, genotype; PrOD, Paritaprevir/ritonavir-ombitasvir and dasabuvir; RBV, ribavirin; SVR12, sustained virological response at 12 weeks after the end of treatment; TE, treatment-experienced; TN, treatment-naïve; SVR, sustained virological response.