Summary of trials of direct acting antivirals in G4-infected patients
| Trial | Phase | Patient characteristics | Treatment history | Number of patients treated—suffering from G4 HCV | Treatment arms | SVR rate (%) |
|---|---|---|---|---|---|---|
| Lawitz et al24 (NEUTRINO) | III | 17% cirrhotic across genotypes | Naïve | 28 | SOF/PR 12 weeks | 96 |
| Kowdley et al25 (ATOMIC) | II | Non-cirrhotic | Naïve | 11 | SOF/PR 24 weeks | 82 |
| Moreno et al26 (RESTORE) | III | Naïve Experienced | 35 22 | SMV/PR 12 weeks, response guided PR SMV/PR 12 weeks, PR 36 weeks | 82.98 6.4 | |
| Hézode et al30 | IIb | Naïve | 30 | DAC 20 mg+PR (RGT) DAC 60 mg+PR (RGT) Placebo+PR 48 weeks | 67 100 50 | |
| Jenson et al31 (HALLMARK-QUAD) | III | 20 cirrhotic 24 non-cirrhotic | Experienced | 44 | DAC/asunaprevir/PR 12 weeks DAC/asunaprevir/PR 12 weeks | 95 100 |
| Ruane et al36 | II | 23% cirrhotic 38% diabetes | Naïve or experienced | 60 | SOF/RBV 12 weeks SOF/RBV 24 weeks | 68 93 |
| Esmat et al37 | II | Naïve Naïve Experienced Experienced | 25 24 27 27 | SOF/RBV 12 weeks SOF/RBV 24 weeks SOF/RBV 12 weeks SOF/RBV 24 weeks | 84 92 70 89 | |
| Kapoor et al38 | IIa | 40% treatment experienced 40% advanced fibrosis 35% Egyptian origin 35% African | Naïve or experienced | 20 | SOF/LDP 12 weeks | 95 |
| El Raziky et al43 (OSIRIS) | IIa | 37% cirrhotic | Naïve or experienced | 63 | SMV+SOF 8 weeks (F0-F3) SMV+SOF 12 weeks (F0-F3) SMV+SOF 12 weeks (F4) | 75 100 100 |
| Feld et al47 | III | 19% compensated cirrhosis across genotypes 32% treatment experienced across genotypes | Naïve or experienced | 116 22 | SOF-VELPATASVIR 12 weeks Matched placebo 12 weeks | 100 0 |
| Pol et al54 (PEARL-1) | IIb | Non-cirrhotic Non-cirrhotic Non-cirrhotic | Naïve Naïve Experienced | 44 42 49 | OMV/PTV/r OMV/PTV/r/RBV OMV/PTV/r/RBV | 90.9 100 100 |
| Hassanein et al59 | IIa | Non-cirrhotic | Naïve | 21 | DAC/asunaprevir/beclabuvir 75 mg DAC/asunaprevir/beclabuvir 150 mg | 100 100 |
| Asselah et al63 | II+III | 36% treatment experienced 22% cirrhotic | Naïve Naïve Experienced Experienced Experienced Experienced | 56 10 9 15 5 8 | GZR/EBR 12 weeks GZR/EBR+RBV 12 weeks GZR/EBR 12 weeks GZR/EBR+RBV 12 weeks GZR/EBR 16 weeks GZR/EBR+RBV 16 weeks | 96 100 78 93 60 100 |
DAC, daclatasvir, GZR/EBR fixed-dose combination tablet Grazoprevir and Elbasvir; LDP, ledipasvir; OMV, ombitasvir; PR, pegylated interferon and ribavirin; PTV/r, paritaprevir/ritonavir; RBV, ribavirin; RGT, response-guided therapy; SMV, simeprevir; SOF, sofosbuvir; SVR sustained virologic response.