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Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis (VALOR-HCV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02128542
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Interventions Drug: Sofosbuvir
Drug: RBV
Enrollment 66
Recruitment Details Participants were enrolled at a total of 15 study sites in the United States The first participant was screened on 04 June 2014. The last study visit occurred on 22 June 2015.
Pre-assignment Details 113 participants were screened.
Arm/Group Title SOF+RBV 12 Weeks (TN) SOF+RBV 12 Weeks (TE)
Hide Arm/Group Description Treatment-naive (TN) participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks. Treatment-experienced participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
Period Title: Overall Study
Started 47 19
Completed 43 19
Not Completed 4 0
Reason Not Completed
Lost to Follow-up             3             0
Withdrew Consent             1             0
Arm/Group Title SOF+RBV 12 Weeks (TN) SOF+RBV 12 Weeks (TE) Total
Hide Arm/Group Description Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks. Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 47 19 66
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 47 participants 19 participants 66 participants
64  (6.0) 62  (5.4) 63  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 19 participants 66 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
47
 100.0%
19
 100.0%
66
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 19 participants 66 participants
Black or African American 8 2 10
White 37 17 54
Hawaiian or Pacific Islander 1 0 1
Other 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 19 participants 66 participants
47 19 66
IL28b Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 19 participants 66 participants
CC 25 8 33
CT 19 10 29
TT 3 1 4
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 47 participants 19 participants 66 participants
5.9  (0.89) 6.6  (0.48) 6.1  (0.87)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 19 participants 66 participants
< 800,000 IU/mL 21 2 23
≥ 800,000 IU/mL 26 17 43
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 19 participants 66 participants
Genotype 2 2 2 4
Genotype 2b 37 17 54
Genotype 2a/2c 8 0 8
Cirrhosis Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 19 participants 66 participants
No 0 0 0
Yes 47 19 66
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 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 enrolled into the study and received at least 1 dose of study drug
Arm/Group Title SOF+RBV 12 Weeks (TN) SOF+RBV 12 Weeks (TE)
Hide Arm/Group Description:
Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
Overall Number of Participants Analyzed 47 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
76.6
(62.0 to 87.7)
84.2
(60.4 to 96.6)
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 12 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 SOF+RBV 12 Weeks (All)
Hide Arm/Group Description:
All participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: Percentage of participants
4.5
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4)
Hide Description SVR4 was defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+RBV 12 Weeks (TN) SOF+RBV 12 Weeks (TE)
Hide Arm/Group Description:
Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
Overall Number of Participants Analyzed 47 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.7
(64.3 to 89.3)
89.5
(66.9 to 98.7)
4.Secondary Outcome
Title Percentage of Participants Experiencing Viral Breakthrough
Hide Description

Viral breakthrough was defined as either:

  • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment
  • HCV RNA ≥ LLOQ at the last available on-treatment measurement with no subsequent follow-up values
Time Frame Up to Posttreatment Weak 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+RBV 12 Weeks (TN) SOF+RBV 12 Weeks (TE)
Hide Arm/Group Description:
Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
Overall Number of Participants Analyzed 47 19
Measure Type: Number
Unit of Measure: Percentage of participants
0 0
5.Secondary Outcome
Title Percentage of Participants Experiencing Viral Relapse
Hide Description Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment.
Time Frame Up to Posttreatment 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+RBV 12 Weeks (TN) SOF+RBV 12 Weeks (TE)
Hide Arm/Group Description:
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
Overall Number of Participants Analyzed 46 19
Measure Type: Number
Unit of Measure: Percentage of participants
17.4 15.8
6.Secondary Outcome
Title Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment
Hide Description Deep sequencing of the HCV NS5B gene was attempted for all participants who had virologic failure at pretreatment and posttreatment time points if the level of HCV RNA in the plasma sample was ≥ 1000 IU/L.
Time Frame Pretreatment and Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who relapsed and qualified for sequencing analysis were analyzed.
Arm/Group Title SOF+RBV 12 Weeks (All)
Hide Arm/Group Description:
All participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
NS5B NI RAV Pretreatment 2
NS5B NI RAV Posttreatment 5
NS5B RBV RAV Pretreatment 0
NS5B RBV RAV Posttreatment 0
Time Frame Up to12 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title SOF+RBV 12 Weeks (All Participants)
Hide Arm/Group Description SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
All-Cause Mortality
SOF+RBV 12 Weeks (All Participants)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
SOF+RBV 12 Weeks (All Participants)
Affected / at Risk (%)
Total   8/66 (12.12%) 
Blood and lymphatic system disorders   
Anaemia  1  1/66 (1.52%) 
Cardiac disorders   
Cardiac failure congestive  1  1/66 (1.52%) 
Gastrointestinal disorders   
Nausea  1  1/66 (1.52%) 
Oesophageal varices haemorrhage  1  1/66 (1.52%) 
General disorders   
Chest pain  1  1/66 (1.52%) 
Infections and infestations   
Bacteraemia  1  1/66 (1.52%) 
Endocarditis staphylococcal  1  1/66 (1.52%) 
Sepsis  1  1/66 (1.52%) 
Musculoskeletal and connective tissue disorders   
Rhabdomyolysis  1  1/66 (1.52%) 
Nervous system disorders   
Drug withdrawal convulsions  1  1/66 (1.52%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  1/66 (1.52%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  1/66 (1.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SOF+RBV 12 Weeks (All Participants)
Affected / at Risk (%)
Total   45/66 (68.18%) 
Blood and lymphatic system disorders   
Anaemia  1  16/66 (24.24%) 
Gastrointestinal disorders   
Diarrhoea  1  4/66 (6.06%) 
Dyspepsia  1  4/66 (6.06%) 
Nausea  1  12/66 (18.18%) 
Vomiting  1  4/66 (6.06%) 
General disorders   
Fatigue  1  22/66 (33.33%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain  1  4/66 (6.06%) 
Nervous system disorders   
Dizziness  1  6/66 (9.09%) 
Headache  1  11/66 (16.67%) 
Psychiatric disorders   
Depression  1  4/66 (6.06%) 
Insomnia  1  4/66 (6.06%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  5/66 (7.58%) 
Skin and subcutaneous tissue disorders   
Rash  1  5/66 (7.58%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02128542    
Other Study ID Numbers: GS-US-334-1379
First Submitted: April 29, 2014
First Posted: May 1, 2014
Results First Submitted: June 21, 2016
Results First Posted: August 3, 2016
Last Update Posted: August 3, 2016