Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant

Study Overview
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Brief Summary
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The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.

Official Title
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A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant

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: History of chronic HCV infection (≥ 6 months) HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate Liver transplant ≥ 3 months prior to screening Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis Key Exclusion Criteria: History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol, Co-infection with HIV or hepatitis B virus Known hypersensitivity to study medication, Use of any prohibited concomitant medications as within with window before the Day 1 visit. De novo or recurrent hepatocellular carcinoma posttransplant 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 FDC for 12 weeks | Drug: SOF/VEL<br>* 400/100 mg tablet administered orally once daily<br>* Other names: GS-7977/GS-5816;|

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 Cessation 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 Prematurely Discontinued Study Drug Due to Any Adverse Event |  | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation 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 Week 2 |  | Week 2 | 
| Percentage of Participants With HCV RNA < LLOQ at Week 4 |  | Week 4 | 
| Percentage of Participants With HCV RNA < LLOQ at Week 8 |  | Week 8 | 
| Percentage of Participants With HCV RNA < LLOQ at Week 12 |  | Week 12 | 
| HCV RNA at Week 2 |  | Week 2 | 
| HCV RNA at Week 4 |  | Week 4 | 
| HCV RNA at Week 8 |  | Week 8 | 
| HCV RNA at Week 12 |  | Week 12 | 
| Change From Baseline in HCV RNA at Week 2 |  | Baseline; Week 2 | 
| Change From Baseline in HCV RNA at Week 4 |  | Baseline; Week 4 | 
| Change From Baseline in HCV RNA at Week 8 |  | Baseline; Week 8 | 
| Change From Baseline in HCV RNA at Week 12 |  | Baseline; Week 12 | 
| 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 on 2 consecutive measurements 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 12 weeks of treatment) Virologic 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 12 |