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Trial record 3 of 11 for:    GS-9451 OR Vedroprevir

Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis

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ClinicalTrials.gov Identifier: NCT02226549
Recruitment Status : Completed
First Posted : August 27, 2014
Results First Posted : March 4, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Interventions Drug: LDV/SOF
Drug: VDV
Drug: RBV
Enrollment 47
Recruitment Details Participants were enrolled at 1 study site in the United States. The first participant was screened on 24 July 2014. The last study visit occurred on 06 February 2015.
Pre-assignment Details 72 participants were screened.
Arm/Group Title LDV/SOF+VDV LDV/SOF+VDV+RBV
Hide Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet + vedroprevir (VDV) 80 mg tablet once daily for 8 weeks LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
Period Title: Overall Study
Started 23 24
Completed 22 23
Not Completed 1 1
Reason Not Completed
Randomized but Never Treated             1             0
Lost to Follow-up             0             1
Arm/Group Title LDV/SOF+VDV LDV/SOF+VDV+RBV Total
Hide Arm/Group Description LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 22 24 46
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 24 participants 46 participants
58  (7.9) 56  (7.7) 57  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
Female
10
  45.5%
6
  25.0%
16
  34.8%
Male
12
  54.5%
18
  75.0%
30
  65.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
Black or African American 1 1 2
White 21 23 44
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
Hispanic or Latino 6 11 17
Not Hispanic or Latino 16 12 28
Not Permitted 0 1 1
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
Genotype 1a 14 18 32
Genotype 1b 7 6 13
Genotype 1a,1b 1 0 1
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 46 participants
CC 4 1 5
CT 12 16 28
TT 6 6 12
Missing 0 1 1
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title LDV/SOF+VDV LDV/SOF+VDV+RBV
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
Overall Number of Participants Analyzed 22 24
Measure Type: Number
Unit of Measure: percentage of participants
95.5 87.5
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame Up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who received at least 1 dose of study drug.
Arm/Group Title LDV/SOF+VDV LDV/SOF+VDV+RBV
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
Overall Number of Participants Analyzed 22 24
Measure Type: Number
Unit of Measure: percentage of participants
0 8.3
3.Secondary Outcome
Title Percentage of Participants With SVR at 4 Weeks After Discontinuation 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 LDV/SOF+VDV LDV/SOF+VDV+RBV
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
Overall Number of Participants Analyzed 22 24
Measure Type: Number
Unit of Measure: percentage of participants
95.5 95.8
Time Frame Up to 8 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who received at least 1 dose of study drug.
 
Arm/Group Title LDV/SOF+VDV LDV/SOF+VDV+RBV
Hide Arm/Group Description LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
All-Cause Mortality
LDV/SOF+VDV LDV/SOF+VDV+RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF+VDV LDV/SOF+VDV+RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF+VDV LDV/SOF+VDV+RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   7/22 (31.82%)   12/24 (50.00%) 
General disorders     
Fatigue  1  0/22 (0.00%)  2/24 (8.33%) 
Infections and infestations     
Sinusitis  1  2/22 (9.09%)  3/24 (12.50%) 
Nervous system disorders     
Headache  1  3/22 (13.64%)  5/24 (20.83%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/22 (0.00%)  2/24 (8.33%) 
Skin and subcutaneous tissue disorders     
Rash  1  2/22 (9.09%)  3/24 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
There were no limitations affecting the analysis or results.
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
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02226549     History of Changes
Other Study ID Numbers: GS-US-337-1512
First Submitted: August 25, 2014
First Posted: August 27, 2014
Results First Submitted: February 5, 2016
Results First Posted: March 4, 2016
Last Update Posted: November 16, 2018