Summary of key clinical trials of SOF-containing regimens.
| Study (NCT) | Year | Trial design | Regimen (dose) | Duration (week) | GT distribution (%) | SVR12 (n/N, %) | Notes |
|---|---|---|---|---|---|---|---|
| ASTRAL-1 (NCT02201940) | 2015 | Phase 3, double-blind, placebo-controlled study | SOF/VEL (400/100 mg) | 12 | GT1 (53), GT2 (17), GT4 (19), GT5 (6), GT6 (7) | 622/624 (99) | Treatment-naïve and treatment experience/compensated cirrhosis |
| ASTRAL-2 (NCT02220998) | 2015 | Phase 3, randomized, open-label, multicenter | SOF/VEL (400/100 mg) | 12 | GT2 (100) | 133/134 (99) | Treatment-experienced and compensated cirrhosis patients |
| ASTRAL-3 (NCT02201953) | 2015 | Phase 3, randomized, open-label, multicenter | SOF/VEL (400/100 mg) | 12 | GT3 (100) | 264/277 (95) | Treatment-experienced and compensated cirrhosis patients |
| ASTRAL-4 (NCT02201901) | 2018 | Phase 3, randomized, open-label trial, multicenter | SOF/VEL (400/100 mg) ± RBV | 12 vs. 24 | GT1 (78), GT2 (4), GT3 (15), GT4 (3), GT6 (< 1) | 75/90 (83) for 12 weeks SOF/VEL77/90 (86) for SOF/VEL 24 weeks | Decompensated cirrhosis, treatment-naïve and treatment compensated |
| ION-1 (NCT01701401) | 2014 | Phase 3, open-label study | LDV/SOF (90/400 mg) ± RBV | 12 vs. 24 | GT1 (100) | 211/214 (99) for 12 weeks LDV/SOF, 211/217 (97) for 12 weeks LDV/SOF + RBV, 212/217 (98) for 24 weeks LDV/SOF, 215/217 (99) for 24 weeks LDV/SOF + RBV | Treatment-naïve only, including cirrhosis |
| ION-2 (NCT01768286) | 2014 | Phase 3, randomized, open-label, multicenter | LDV/SOF (90/400 mg) ± RBV | 12 vs. 24 | GT1 (100) | 109 (93.6) for 12-week LDV/SOF, 96% for 12-week LDV/SOF + RBV, 99% for 24 weeks LDV/SOF ± RBV | Included treatment-experienced and cirrhotic patients |
| ION-3 (NCT01851330) | 2014 | Phase 3, open-label study | LDV/SOF (90/400 mg) ± RBV | 8 vs. 12 | GT1 (100) | 94% for 8 weeks LDV/SOF, 93% for 8 weeks LDV/SOF + RBV, 95% for 12 weeks LDV/SOF | Treatment-naïve without cirrhosis |
| POLARIS-1 (NCT02607735) | 2017 | Phase 3, randomized, double blind, multi-center | SOF/VEL/VOX (400 mg/100 mg/100 mg) | 12 | GT1 (72), GT2 (1), GT3 (19), GT4 (5), GT5 (< 1), GT6 (2) | 253/263 (96.2) | Treatment-experienced patients, including cirrhotic patients |
| POLARIS-4 (NCT02639247) | 2017 | Phase 3, randomized, open-label, multi-center | SOF/VEL/VOX (400 mg/100 mg/100 mg) | 12 | GT1 (43), GT2 (19), GT3 (32), GT4 (6) | 178/182 (98) | Treatment-experienced patients, including cirrhotic patients |
GT: genotype; SVR12: sustained virologic response 12 weeks post-treatment; SOF/VEL: sofosbuvir/velpatasvir; RBV: ribavirin; LDV/SOF: ledipasvir/sofosbuvir.
SHB: Conceptualization, Investigation, Writing—original draft, Writing—review & editing. ABER: Conceptualization, Investigation, Writing—review & editing, Supervision. KHH: Writing—review & editing. All authors read and approved the submitted version.
Kareem H. Hassan and Azza B. El-Remessy are employed by Nour Therapeutics. Nour Therapeutics had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results. Besides, these two authors have no other conflicts of interest that need to be disclosed. Salma H. Bahram has no conflicts of interest that need to be disclosed.
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