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Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant

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ClinicalTrials.gov Identifier: NCT01687270
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
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
Conditions Recurrent Chronic Hepatitis C Virus
Post Liver Transplant
Interventions Drug: Sofosbuvir
Drug: RBV
Enrollment 40
Recruitment Details Participants were enrolled at a total of 12 study sites in the United States, Europe, and New Zealand. The first participant was screened on 26 October 2012. The last participant observation occurred on 14 August 2014.
Pre-assignment Details 49 participants were screened.
Arm/Group Title SOF+RBV
Hide Arm/Group Description Sofosbuvir (SOF) 400 mg tablet once daily plus ribavirin (RBV) tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
Period Title: Overall Study
Started 40
Completed 28
Not Completed 12
Reason Not Completed
Lack of Efficacy             11
Lost to Follow-up             1
Arm/Group Title SOF+RBV
Hide Arm/Group Description SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
Safety Analysis Set: participants were enrolled and received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
59  (6.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
9
  22.5%
Male
31
  77.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Hispanic or Latino
1
   2.5%
Not Hispanic or Latino
39
  97.5%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
White 34
Black 3
Asian 2
Other 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
France 3
United States 28
Spain 3
Germany 3
New Zealand 3
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 40 participants
6.55  (0.751)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
< 6 log10 IU/mL 8
6 to 7 log10 IU/mL 20
> 7 log10 IU/mL 12
Prior HCV Treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
No 5
Yes 35
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
Genotype 1A 22
Genotype 1B 11
Genotype 3A 5
Genotype 3B 1
Genotype 4 1
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
CC 13
CT 16
TT 11
[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 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants were enrolled and received at least one dose of study medication.
Arm/Group Title SOF+RBV
Hide Arm/Group Description:
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of participants
70.0
2.Primary Outcome
Title Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title SOF+RBV
Hide Arm/Group Description:
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of participants
5.0
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
Hide Description SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.
Time Frame Posttreatment Weeks 4, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+RBV
Hide Arm/Group Description:
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of participants
SVR4 72.5
SVR24 70.0
SVR48 70.0
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24
Hide Description [Not Specified]
Time Frame Weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF+RBV
Hide Arm/Group Description:
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 (n = 40) 100.00
Week 24 (n = 38) 100.00
5.Secondary Outcome
Title HCV RNA and Change From Baseline at Weeks 2, 4, and 8
Hide Description [Not Specified]
Time Frame Baseline; Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF+RBV
Hide Arm/Group Description:
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Week 2 (n = 39) 1.65  (0.370)
Change from baseline at Week 2 (n = 39) -4.89  (0.692)
Week 4 (n = 40) 1.38  (0.000)
Change from baseline at Week 4 (n = 40) -5.17  (0.751)
Week 8 (n = 40) 1.38  (0.005)
Change from baseline at Week 8 (n = 40) -5.17  (0.752)
6.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

Virologic failure was defined as on-treatment virologic failure or virologic relapse.

  • On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment
  • Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)
Time Frame Up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+RBV
Hide Arm/Group Description:
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of participants
On-treatment virologic failure 0
Virologic relapse 30.0
Time Frame Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis set
 
Arm/Group Title SOF+RBV
Hide Arm/Group Description SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
All-Cause Mortality
SOF+RBV
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SOF+RBV
Affected / at Risk (%)
Total   6/40 (15.00%) 
Gastrointestinal disorders   
Ascites  1  1/40 (2.50%) 
General disorders   
Pyrexia  1  2/40 (5.00%) 
Hepatobiliary disorders   
Jaundice  1  1/40 (2.50%) 
Infections and infestations   
Pneumonia  1  1/40 (2.50%) 
Urinary tract infection  1  1/40 (2.50%) 
Injury, poisoning and procedural complications   
Compression fracture  1  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders   
Haemarthrosis  1  1/40 (2.50%) 
Psychiatric disorders   
Confusional state  1  1/40 (2.50%) 
Hallucination  1  1/40 (2.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SOF+RBV
Affected / at Risk (%)
Total   39/40 (97.50%) 
Blood and lymphatic system disorders   
Anaemia  1  8/40 (20.00%) 
Lymphopenia  1  2/40 (5.00%) 
Cardiac disorders   
Palpitations  1  3/40 (7.50%) 
Gastrointestinal disorders   
Diarrhoea  1  11/40 (27.50%) 
Nausea  1  8/40 (20.00%) 
Vomiting  1  4/40 (10.00%) 
Oral lichen planus  1  3/40 (7.50%) 
Abdominal distension  1  2/40 (5.00%) 
Abdominal pain upper  1  2/40 (5.00%) 
Constipation  1  2/40 (5.00%) 
Dyspepsia  1  2/40 (5.00%) 
General disorders   
Fatigue  1  12/40 (30.00%) 
Asthenia  1  4/40 (10.00%) 
Oedema peripheral  1  3/40 (7.50%) 
Pyrexia  1  2/40 (5.00%) 
Infections and infestations   
Bronchitis  1  3/40 (7.50%) 
Candida infection  1  2/40 (5.00%) 
Nasopharyngitis  1  2/40 (5.00%) 
Sinusitis  1  2/40 (5.00%) 
Upper respiratory tract infection  1  2/40 (5.00%) 
Injury, poisoning and procedural complications   
Contusion  1  2/40 (5.00%) 
Laceration  1  2/40 (5.00%) 
Investigations   
Blood creatinine increased  1  2/40 (5.00%) 
Metabolism and nutrition disorders   
Hypomagnesaemia  1  2/40 (5.00%) 
Hypophosphataemia  1  2/40 (5.00%) 
Increased appetite  1  2/40 (5.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  9/40 (22.50%) 
Muscle spasms  1  4/40 (10.00%) 
Pain in extremity  1  3/40 (7.50%) 
Back pain  1  2/40 (5.00%) 
Nervous system disorders   
Headache  1  10/40 (25.00%) 
Dizziness  1  3/40 (7.50%) 
Psychiatric disorders   
Anxiety  1  5/40 (12.50%) 
Insomnia  1  5/40 (12.50%) 
Irritability  1  4/40 (10.00%) 
Depression  1  3/40 (7.50%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  7/40 (17.50%) 
Dyspnoea  1  4/40 (10.00%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  3/40 (7.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
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, Inc.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01687270     History of Changes
Other Study ID Numbers: GS-US-334-0126
2012-002417-19 ( EudraCT Number )
First Submitted: September 12, 2012
First Posted: September 18, 2012
Results First Submitted: December 11, 2014
Results First Posted: December 19, 2014
Last Update Posted: December 19, 2014