Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

Official Title
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A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection

Conditions
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Hepatitis C Virus Infection

Intervention / Treatment
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* Drug: SOF/VEL


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: HCV RNA ≥ 10^4 IU/mL at screening Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy Key Exclusion Criteria: Any other chronic liver disease Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Clinical hepatic decompensation Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOF/VEL<br>SOF/VEL for 12 weeks | Drug: SOF/VEL<br>* 400/100 mg FDC tablet administered orally once daily<br>* Other names: Epclusa®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. | Posttreatment Week 12 | 
| Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event |  | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. | Posttreatment Week 4 | 
| Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) | SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. | Posttreatment Week 24 | 
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1 |  | Week 1 | 
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2 |  | Week 2 | 
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4 |  | Week 4 | 
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8 |  | Week 8 | 
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12 |  | Week 12 | 
| Change From Baseline in HCV RNA at Week 1 |  | Baseline (Day 1); Week 1 | 
| Change From Baseline in HCV RNA at Week 2 |  | Baseline (Day 1); Week 2 | 
| Change From Baseline in HCV RNA at Week 4 |  | Baseline (Day 1); Week 4 | 
| Change From Baseline in HCV RNA at Week 8 |  | Baseline (Day 1); Week 8 | 
| Change From Baseline in HCV RNA at Week 12 |  | Baseline (Day 1); Week 12 | 
| Percentage of Participants With Virologic Failure | Virologic failure was defined as: 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 Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement) | Up to Posttreatment Week 24 |