Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
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|ClinicalTrials.gov Identifier: NCT02671500|
Recruitment Status : Completed
First Posted : February 2, 2016
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus Infection||Drug: SOF/VEL||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||375 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV|
|Actual Study Start Date :||April 19, 2016|
|Actual Primary Completion Date :||January 5, 2018|
|Actual Study Completion Date :||March 27, 2018|
SOF/VEL FDC for 12 weeks
SOF/VEL (400/100 mg) FDC tablet administered orally once daily
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
- Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
- Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
- Percentage of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Weeks 1, 2, 4, 6, 8, 10, and 12 ]
- Change From Baseline in HCV RNA [ Time Frame: Baseline and up to Week 12 ]
- Percentage of Participants With Overall Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]Virologic failure was defined as: (1) 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) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671500
|Study Director:||Gilead Study Director||Gilead Sciences|