Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
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ClinicalTrials.gov Identifier: NCT02781571 |
Recruitment Status :
Completed
First Posted : May 24, 2016
Results First Posted : August 21, 2018
Last Update Posted : November 14, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C Virus Infection | Drug: SOF/VEL | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 27, 2016 |
Actual Primary Completion Date : | July 28, 2017 |
Actual Study Completion Date : | July 28, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: SOF/VEL
SOF/VEL FDC for 12 weeks
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Drug: SOF/VEL
400/100 mg tablet administered orally once daily
Other Names:
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- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
- Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event [ Time Frame: Up to 12 weeks ]
- Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation 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 HCV RNA < LLOQ at Week 2 [ Time Frame: Week 2 ]
- Percentage of Participants With HCV RNA < LLOQ at Week 4 [ Time Frame: Week 4 ]
- Percentage of Participants With HCV RNA < LLOQ at Week 8 [ Time Frame: Week 8 ]
- Percentage of Participants With HCV RNA < LLOQ at Week 12 [ Time Frame: Week 12 ]
- HCV RNA at Week 2 [ Time Frame: Week 2 ]
- HCV RNA at Week 4 [ Time Frame: Week 4 ]
- HCV RNA at Week 8 [ Time Frame: Week 8 ]
- HCV RNA at Week 12 [ Time Frame: Week 12 ]
- Change From Baseline in HCV RNA at Week 2 [ Time Frame: Baseline; Week 2 ]
- Change From Baseline in HCV RNA at Week 4 [ Time Frame: Baseline; Week 4 ]
- Change From Baseline in HCV RNA at Week 8 [ Time Frame: Baseline; Week 8 ]
- Change From Baseline in HCV RNA at Week 12 [ Time Frame: Baseline; Week 12 ]
- Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 12 ]
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT02781571
Spain | |
Hospital Clínic de Barcelona | |
Barcelona, Spain | |
Hospital Universitari Vall d'Hebron | |
Barcelona, Spain | |
Reina Sofía University Hospital | |
Córdoba, Spain | |
Hospital General Universitario Gregorio Maranon | |
Madrid, Spain | |
Hospital Ramón Y Cajal | |
Madrid, Spain | |
Hospital Universitario Virgen del Rocío | |
Sevilla, Spain | |
La Fe Hospital | |
Valencia, Spain | |
Hospital Clinico Zaragoza | |
Zaragoza, Spain | |
Switzerland | |
Universität Bern | |
Bern, Switzerland | |
University Hospital Zurich | |
Zürich, Switzerland | |
United Kingdom | |
Cambridge University Hospitals NHS Foundation Trust | |
Cambridge, United Kingdom | |
Royal Infirmary of Edinburgh | |
Edinburgh, United Kingdom | |
St James University Hospital | |
Leeds, United Kingdom | |
Kings College Hospital | |
London, United Kingdom | |
Royal Free Hampstead NHS Trust | |
London, United Kingdom |
Study Director: | Gilead Study Director | Gilead Sciences |
Documents provided by Gilead Sciences:
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT02781571 |
Other Study ID Numbers: |
GS-US-342-2104 2016-000416-15 ( EudraCT Number ) |
First Posted: | May 24, 2016 Key Record Dates |
Results First Posted: | August 21, 2018 |
Last Update Posted: | November 14, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | 18 months after study completion |
Access Criteria: | A secured external environment with username, password, and RSA code. |
URL: | http://www.gilead.com/research/disclosure-and-transparency |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Infections Communicable Diseases Hepatitis A Hepatitis C Virus Diseases Hepatitis Disease Attributes Pathologic Processes Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Flaviviridae Infections Sofosbuvir Sofosbuvir-velpatasvir drug combination Velpatasvir Antiviral Agents Anti-Infective Agents |