Summary of key clinical trials of the G/P regimen.
| Study (NCT) | Year | Trial design | Regimen (dose) | Duration (week) | GT distribution (%) | SVR12 (n/N, %) | Notes |
|---|---|---|---|---|---|---|---|
| ENDURANCE-1 (NCT02604017) | 2018 | Phase 3, randomized, open-label, multicenter | G/P (300/120 mg) | 8 vs. 12 | GT1 (100) | 699/703 (99.43) | HIV-1-co-infection and SOF-treatment-experienced patients |
| ENDURANCE-2 (NCT02640482) | 2018 | Phase 3, randomized, double-blind, placebo-controlled | G/P (300/120 mg) | 12 | GT2 (100) | 201/202 (99.5) | Treatment-experienced patients |
| ENDURANCE-3 (NCT02640157) | 2018 | Phase 3, partially randomized, open-label, multicenter | G/P (300/120 mg) | 8 vs. 12 | GT3 | 371/390 (95) | Treatment-experienced patients |
| SOF/DCV (400/60 mg) | 13 | GT3 | 111/115 (97) | ||||
| ENDURANCE-4 (NCT02636595) | 2018 | Phase 3, open-label, single-arm | G/P (300/120 mg) | 12 | GT4 (45), GT5 (15), GT6 (40) | 120/121 (99.17) | Treatment-experienced patients |
| ENDURANCE-5, 6 (NCT02966795) | 2019 | Phase 3b, single-arm, open-label, multicenter | G/P (300/120 mg) | 8 vs. 12 | GT5 (27.4), GT6 (72.6) | 82/84 (97.6) | Included treatment-experienced patients |
| EXPEDITION-1 (NCT02642432) | 2017 | Phase 3, open-label, multicenter | G/P (300/120 mg) | 12 | GT1 (60), GT2 (23), GT4 (11), GT5 (1), GT6 (5) | 145/146 (99) | Compensated cirrhosis, including treatment-experienced patients |
| EXPEDITION-2 | 2018 | Phase 3, open-label, multicenter | G/P (300/120 mg) | 8 vs. 12 | GT1–GT6 | 150/153 (98) | HIV-1-coinfected/compensated cirrhosis and treatment-experienced PT |
| EXPEDITION-8 (NCT03656744) | 2023 | Phase 3b, single-arm, multicenter | G/P (300/120 mg) | 8 | GT1 (67), GT2 (8), GT3 (18), GT4 (4), GT5 (< 1), GT6 (3) | 335/343 (97.7) | Treatment-naïve, compensated cirrhosis patients |
| SURVEYOR-II | 2018 | Phase 3, partially randomized, open-label, multicenter | G/P (300/120 mg) | 12 vs. 16 | GT3 (100) | 59/62 (95) for 12 weeks, 66/69 (96) for 16 weeks | Treatment-experienced ± compensated cirrhosis and treatment-naïve with compensated cirrhosis |
GT: genotype; SVR12: sustained virologic response 12 weeks post-treatment; G/P: glecaprevir/pibrentasvir; SOF/DCV: sofosbuvir/daclatasvir; HIV: human immunodeficiency virus.
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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