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Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

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: NCT01625338
Recruitment Status : Completed
First Posted : June 21, 2012
Results First Posted : November 9, 2015
Last Update Posted : November 9, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: SOF
Drug: RBV
Drug: Peg-IFN
Enrollment 534
Recruitment Details Participants were enrolled at a total of 152 study sites from their prior Gilead study in North America, Europe, Australia, and New Zealand. The first participant was screened on 22 June 2012. The last study visit occurred on 22 December 2014.
Pre-assignment Details 585 participants were screened.
Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Hide Arm/Group Description Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (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 24 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks in participants
Period Title: Overall Study
Started 114 200 220
Completed 82 156 181
Not Completed 32 44 39
Reason Not Completed
Enrolled but not Treated             0             0             1
Efficacy Failure             27             39             31
Lost to Follow-up             3             3             2
Investigator Decision             0             2             1
Subject Withdrew Consent             1             0             2
Adverse Event             1             0             1
Study Discontinued by Sponsor             0             0             1
Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks Total
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 24 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants Total of all reporting groups
Overall Number of Baseline Participants 114 200 219 533
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 200 participants 219 participants 533 participants
53  (9.6) 52  (7.6) 53  (10.0) 53  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 200 participants 219 participants 533 participants
Female
54
  47.4%
50
  25.0%
60
  27.4%
164
  30.8%
Male
60
  52.6%
150
  75.0%
159
  72.6%
369
  69.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 200 participants 219 participants 533 participants
White 105 184 187 476
Black Or African American 4 2 20 26
Asian 2 6 8 16
Other 1 3 2 6
Not Permitted 0 2 2 4
American Indian Or Alaska Native 2 1 0 3
Native Hawaiian Or Other Pacific Islander 0 2 0 2
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 200 participants 219 participants 533 participants
Hispanic or Latino 19 12 20 51
Not Hispanic or Latino 95 187 197 479
Not Permitted 0 1 2 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 200 participants 219 participants 533 participants
United States 77 82 121 280
United Kingdom 3 10 8 21
Spain 1 8 2 11
New Zealand 4 30 6 40
Canada 7 13 10 30
Austria 1 2 1 4
Netherlands 2 4 4 10
Sweden 2 5 3 10
Czech Republic 0 0 1 1
Poland 0 1 8 9
Italy 3 7 4 14
Australia 9 14 19 42
France 2 10 11 23
Germany 2 12 18 32
Estonia 1 2 3 6
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 200 participants 219 participants 533 participants
Genotype 1 0 2 134 136
Genotype 2 62 10 8 80
Genotype 3 52 180 74 306
Genotype 4 0 7 3 10
Indeterminate 0 1 0 1
Cirrhosis Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 200 participants 219 participants 533 participants
No 89 138 183 410
Yes 25 62 36 123
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 200 participants 219 participants 533 participants
CC 38 59 47 144
CT 61 103 127 291
TT 13 35 40 88
Missing 2 3 5 10
[1]
Measure Description: 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 114 participants 200 participants 219 participants 533 participants
6.3  (0.87) 6.4  (0.70) 6.4  (0.64) 6.4  (0.72)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 200 participants 219 participants 533 participants
< 800,000 IU/mL 30 44 36 110
≥ 800,000 IU/mL 84 156 183 423
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, 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 and received at least 1 dose of study drug.
Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
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 24 weeks
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
Overall Number of Participants Analyzed 114 200 219
Measure Type: Number
Unit of Measure: percentage of participants
71.9 77.5 82.6
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 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
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 24 weeks
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
Overall Number of Participants Analyzed 114 200 219
Measure Type: Number
Unit of Measure: percentage of participants
0.9 1.0 3.7
3.Secondary Outcome
Title Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Hide Description SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time Frame Posttreatment Weeks 4 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
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 24 weeks
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
Overall Number of Participants Analyzed 114 200 219
Measure Type: Number
Unit of Measure: percentage of participants
SVR4 73.7 81.5 87.2
SVR24 71.9 76.0 82.6
4.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure
Hide Description

On-treatment virologic failure was defined as

  • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ 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 8 weeks of treatment)
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
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 24 weeks
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
Overall Number of Participants Analyzed 114 200 219
Measure Type: Number
Unit of Measure: percentage of participants
0.9 0.5 0
5.Secondary Outcome
Title Percentage of Participants With Viral Relapse
Hide Description Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Time Frame Up to Posttreatment Week 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 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
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 24 weeks
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
Overall Number of Participants Analyzed 113 199 219
Measure Type: Number
Unit of Measure: percentage of participants
25.7 20.6 16.4
Time Frame Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
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 24 weeks SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
All-Cause Mortality
SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/114 (3.51%)   11/200 (5.50%)   4/219 (1.83%) 
Gastrointestinal disorders       
Abdominal pain  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Dysphagia  1  0/114 (0.00%)  0/200 (0.00%)  1/219 (0.46%) 
Haemorrhoidal haemorrhage  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Infections and infestations       
Meningitis aseptic  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Injury, poisoning and procedural complications       
Ligament rupture  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Multiple injuries  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Post procedural haemorrhage  1  1/114 (0.88%)  0/200 (0.00%)  0/219 (0.00%) 
Road traffic accident  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Musculoskeletal and connective tissue disorders       
Rotator cuff syndrome  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hepatocellular carcinoma  1  1/114 (0.88%)  1/200 (0.50%)  0/219 (0.00%) 
Nervous system disorders       
Headache  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Myelitis transverse  1  1/114 (0.88%)  0/200 (0.00%)  0/219 (0.00%) 
Presyncope  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Psychiatric disorders       
Affective disorder  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Insomnia  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Mania  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Psychotic disorder  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Substance-induced psychotic disorder  1  0/114 (0.00%)  0/200 (0.00%)  1/219 (0.46%) 
Suicide attempt  1  1/114 (0.88%)  0/200 (0.00%)  1/219 (0.46%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/114 (0.00%)  0/200 (0.00%)  1/219 (0.46%) 
Social circumstances       
Social stay hospitalisation  1  0/114 (0.00%)  1/200 (0.50%)  0/219 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   92/114 (80.70%)   167/200 (83.50%)   194/219 (88.58%) 
Blood and lymphatic system disorders       
Anaemia  1  13/114 (11.40%)  12/200 (6.00%)  26/219 (11.87%) 
Leukopenia  1  0/114 (0.00%)  0/200 (0.00%)  11/219 (5.02%) 
Neutropenia  1  0/114 (0.00%)  0/200 (0.00%)  38/219 (17.35%) 
Gastrointestinal disorders       
Abdominal pain  1  6/114 (5.26%)  7/200 (3.50%)  5/219 (2.28%) 
Diarrhoea  1  7/114 (6.14%)  14/200 (7.00%)  28/219 (12.79%) 
Nausea  1  22/114 (19.30%)  27/200 (13.50%)  52/219 (23.74%) 
Vomiting  1  7/114 (6.14%)  7/200 (3.50%)  9/219 (4.11%) 
General disorders       
Asthenia  1  5/114 (4.39%)  9/200 (4.50%)  19/219 (8.68%) 
Chills  1  2/114 (1.75%)  3/200 (1.50%)  19/219 (8.68%) 
Fatigue  1  33/114 (28.95%)  66/200 (33.00%)  97/219 (44.29%) 
Influenza like illness  1  6/114 (5.26%)  5/200 (2.50%)  45/219 (20.55%) 
Pain  1  2/114 (1.75%)  4/200 (2.00%)  17/219 (7.76%) 
Pyrexia  1  5/114 (4.39%)  1/200 (0.50%)  27/219 (12.33%) 
Infections and infestations       
Nasopharyngitis  1  9/114 (7.89%)  22/200 (11.00%)  4/219 (1.83%) 
Upper respiratory tract infection  1  7/114 (6.14%)  9/200 (4.50%)  2/219 (0.91%) 
Metabolism and nutrition disorders       
Decreased appetite  1  3/114 (2.63%)  8/200 (4.00%)  32/219 (14.61%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  13/114 (11.40%)  21/200 (10.50%)  37/219 (16.89%) 
Back pain  1  9/114 (7.89%)  11/200 (5.50%)  13/219 (5.94%) 
Muscle spasms  1  7/114 (6.14%)  17/200 (8.50%)  11/219 (5.02%) 
Myalgia  1  8/114 (7.02%)  9/200 (4.50%)  45/219 (20.55%) 
Nervous system disorders       
Dizziness  1  4/114 (3.51%)  13/200 (6.50%)  23/219 (10.50%) 
Dysgeusia  1  3/114 (2.63%)  0/200 (0.00%)  12/219 (5.48%) 
Headache  1  15/114 (13.16%)  57/200 (28.50%)  71/219 (32.42%) 
Psychiatric disorders       
Anxiety  1  6/114 (5.26%)  11/200 (5.50%)  14/219 (6.39%) 
Depression  1  7/114 (6.14%)  21/200 (10.50%)  14/219 (6.39%) 
Insomnia  1  18/114 (15.79%)  34/200 (17.00%)  37/219 (16.89%) 
Irritability  1  5/114 (4.39%)  27/200 (13.50%)  38/219 (17.35%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  11/114 (9.65%)  11/200 (5.50%)  33/219 (15.07%) 
Dyspnoea  1  6/114 (5.26%)  12/200 (6.00%)  11/219 (5.02%) 
Dyspnoea exertional  1  5/114 (4.39%)  7/200 (3.50%)  13/219 (5.94%) 
Oropharyngeal pain  1  3/114 (2.63%)  4/200 (2.00%)  12/219 (5.48%) 
Skin and subcutaneous tissue disorders       
Dry skin  1  6/114 (5.26%)  14/200 (7.00%)  17/219 (7.76%) 
Pruritus  1  15/114 (13.16%)  23/200 (11.50%)  40/219 (18.26%) 
Rash  1  13/114 (11.40%)  19/200 (9.50%)  35/219 (15.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 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
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: NCT01625338    
Other Study ID Numbers: GS-US-334-0109
2012-000571-16 ( EudraCT Number )
First Submitted: June 7, 2012
First Posted: June 21, 2012
Results First Submitted: October 9, 2015
Results First Posted: November 9, 2015
Last Update Posted: November 9, 2015