| Outcome Measures: |
Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12), SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method., Posttreatment Week 12|Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event, First dose date up to Week 24 | Secondary: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4), SVR4 was defined as HCV RNA \< LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method., Posttreatment Week 4|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24), SVR24 was defined as HCV RNA \< LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method., Posttreatment Week 24|Percentage of Participants With HCV RNA < LLOQ on Treatment, The total number of participants with HCV RNA \< LLOQ was the sum of the number of participants with HCV RNA "\< LLOQ detected" plus the number of participants with HCV RNA "\< LLOQ target not detected (TND)". LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method., Weeks 2, 4, 6, 8, 12, 16, 20, 24|HCV RNA, Weeks 2, 4, 6, 8, 12, 16, 20, 24|Change From Baseline in HCV RNA, Weeks 2, 4, 6, 8, 12, 16, 20, 24|Percentage of Participants With Virologic Failure, Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit., Baseline up to Posttreatment Week 24|Percentage of Participants Who Developed Resistance to LDV and SOF, Baseline up to Posttreatment Week 24|Pharmacokinetics (PK) Parameter: AUCtau of LDV, AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval., Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))|PK Parameter: AUCtau of SOF, AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval., Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))|PK Parameter: AUCtau of GS-331007 (Metabolite of SOF), AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval., Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))|PK Parameter: Cmax of LDV, Cmax is defined as the population PK derived maximum concentration of the drug., Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))|PK Parameter: Cmax of SOF, Cmax is defined as the population PK derived maximum concentration of the drug., Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))|PK Parameter: Cmax of GS-331007 (Metabolite of SOF), Cmax is defined as the population PK derived maximum concentration of the drug., Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
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| Locations: |
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Henry Ford Health System, Detroit, Michigan, 48202, United States|James J. Peters VA Hospital, Bronx, New York, 10468, United States|The Liver Institute at Methodist Dallas Medical Center, Dallas, Texas, 75203, United States|Texas Liver Institute/American Research Corporation, San Antonio, Texas, 78215, United States|University of Washington/Harborview Medical Center, Seattle, Washington, 98104, United States|CUB Hopital Erasme, Brussels, 1070, Belgium|Cliniques Universitaires UCL Saint-Luc, Brussels, 1200, Belgium|Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt, 60590, Germany|Universitatsklinikum Hamburg-Eppendorf (UKE), Zentrum fur Innere Medizin - Studienambulanz Hepatol., Hamburg, 20246, Germany|Ifi Studien und Projekt GmbH an der Asklepios Klinik St. Georg, Hamburg, 20251, Germany|Universitätsklinikum Leipzig, Leipzig, 04103, Germany|IRCCS Ospedale Casa Sollievo Della Sofferrenza, San Giovanni Rotondo, Foggia, 71013, Italy|Ospedale Santa Maria Annunziata, Antella, 50011, Italy|Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, 20122, Italy|Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, 10126, Italy|Changhua Christian Hospital, Changhua, 500, Taiwan|Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, 80756, Taiwan|Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, 83301, Taiwan|China Medical University Hospital, Taichung, 40447, Taiwan|National Taiwan University Hospital, Taipei, 10002, Taiwan
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