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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
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Intervention Drug: SOF/VEL
Enrollment 79
Recruitment Details Participants were enrolled at study sites in Spain, Switzerland, and the United Kingdom. The first participant was screened on 27 July 2016. The last study visit occurred on 28 July 2017.
Pre-assignment Details 85 participants were screened.
Arm/Group Title SOF/VEL
Hide Arm/Group Description Sofosbuvir/Velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Period Title: Overall Study
Started 79
Completed 79
Not Completed 0
Arm/Group Title SOF/VEL
Hide Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Baseline Participants 79
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who took at least 1 dose of the study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants
62  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
Female
15
  19.0%
Male
64
  81.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
Hispanic or Latino
2
   2.5%
Not Hispanic or Latino
77
  97.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
American Indian or Alaska Native
0
   0.0%
Asian
12
  15.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   2.5%
White
65
  82.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
United Kingdom
41
  51.9%
Switzerland
7
   8.9%
Spain
31
  39.2%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
CC
39
  49.4%
CT
34
  43.0%
TT
6
   7.6%
[1]
Measure Description: The CC, CT, and TT alleles are different forms of the IL28b gene.
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 79 participants
6.4  (0.55)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
< 800,000 IU/mL
18
  22.8%
≥ 800,000 IU/mL
61
  77.2%
HCV genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
Genotype 1
37
  46.8%
Genotype 2
3
   3.8%
Genotype 3
35
  44.3%
Genotype 4
4
   5.1%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all enrolled participants who took at least 1 dose of the study drug
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.2
(89.3 to 99.2)
2.Primary Outcome
Title Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who took at least 1 dose if the study drug.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: percentage of participants
1.3
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)
Hide Description SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
97.5
(91.2 to 99.7)
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 2
Hide Description [Not Specified]
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.5
(29.6 to 52.1)
5.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 4
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85.9
(76.2 to 92.7)
6.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 8
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.7
(93.1 to 100.0)
7.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 12
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(95.4 to 100.0)
8.Secondary Outcome
Title HCV RNA at Week 2
Hide Description [Not Specified]
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
1.59  (0.596)
9.Secondary Outcome
Title HCV RNA at Week 4
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
1.23  (0.251)
10.Secondary Outcome
Title HCV RNA at Week 8
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 77
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
1.15  (0.00)
11.Secondary Outcome
Title HCV RNA at Week 12
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
1.15  (0.00)
12.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 2
Hide Description [Not Specified]
Time Frame Baseline; Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.75  (0.635)
13.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 4
Hide Description [Not Specified]
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.13  (0.551)
14.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 8
Hide Description [Not Specified]
Time Frame Baseline; Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 77
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.20  (0.548)
15.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 12
Hide Description [Not Specified]
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.22  (0.554)
16.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

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
Time Frame Up to Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: percentage of participants
2.5
Time Frame Up to 12 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who took at least 1 dose of the study drug.
 
Arm/Group Title SOF/VEL
Hide Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
All-Cause Mortality
SOF/VEL
Affected / at Risk (%)
Total   0/79 (0.00%) 
Hide Serious Adverse Events
SOF/VEL
Affected / at Risk (%)
Total   3/79 (3.80%) 
Infections and infestations   
Pneumonia klebsiella  1  1/79 (1.27%) 
Musculoskeletal and connective tissue disorders   
Joint swelling  1  1/79 (1.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatocellular carcinoma  1  1/79 (1.27%) 
1
Term from vocabulary, MedDRA 20
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SOF/VEL
Affected / at Risk (%)
Total   42/79 (53.16%) 
Gastrointestinal disorders   
Diarrhoea  1  6/79 (7.59%) 
Nausea  1  6/79 (7.59%) 
General disorders   
Asthenia  1  5/79 (6.33%) 
Fatigue  1  16/79 (20.25%) 
Infections and infestations   
Influenza  1  5/79 (6.33%) 
Viral upper respiratory tract infection  1  5/79 (6.33%) 
Metabolism and nutrition disorders   
Decreased appetite  1  4/79 (5.06%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  4/79 (5.06%) 
Nervous system disorders   
Headache  1  19/79 (24.05%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  8/79 (10.13%) 
1
Term from vocabulary, MedDRA 20
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02781571    
Other Study ID Numbers: GS-US-342-2104
2016-000416-15 ( EudraCT Number )
First Submitted: May 20, 2016
First Posted: May 24, 2016
Results First Submitted: July 25, 2018
Results First Posted: August 21, 2018
Last Update Posted: November 14, 2018