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Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection

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ClinicalTrials.gov Identifier: NCT02021643
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : February 20, 2018
Last Update Posted : February 20, 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 Chronic HCV Infection
Interventions Drug: Sofosbuvir
Drug: RBV
Drug: PEG
Enrollment 687
Recruitment Details Participants were enrolled at 61 study sites in Asia. The first participant was screened on 10 December 2013. The last study visit occurred on 03 November 2016.
Pre-assignment Details 815 participants were screened.
Arm/Group Title SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
Hide Arm/Group Description Participants with genotype 1 or 6 received Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + Pegylated interferon alfa-2a (PEG) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Period Title: Overall Study
Started 156 290 11 230
Completed 147 280 11 218
Not Completed 9 10 0 12
Reason Not Completed
Enrolled but Never Treated             1             0             0             0
Adverse Event             0             1             0             0
Death             0             1             0             0
Investigator's Discretion             1             0             0             0
Lack of Efficacy             7             6             0             12
Lost to Follow-up             0             1             0             0
Withdrew Consent             0             1             0             0
Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3) Total
Hide Arm/Group Description Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 155 10 11 104 280 126 686
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants 10 participants 11 participants 104 participants 280 participants 126 participants 686 participants
41  (12.8) 43  (17.2) 43  (17.6) 49  (13.3) 53  (12.3) 40  (8.1) 47  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 10 participants 11 participants 104 participants 280 participants 126 participants 686 participants
Female
67
  43.2%
5
  50.0%
2
  18.2%
61
  58.7%
160
  57.1%
56
  44.4%
351
  51.2%
Male
88
  56.8%
5
  50.0%
9
  81.8%
43
  41.3%
120
  42.9%
70
  55.6%
335
  48.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 155 participants 10 participants 11 participants 104 participants 280 participants 126 participants 686 participants
155
 100.0%
10
 100.0%
11
 100.0%
104
 100.0%
280
 100.0%
126
 100.0%
686
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 10 participants 11 participants 104 participants 280 participants 126 participants 686 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
151
  97.4%
10
 100.0%
11
 100.0%
98
  94.2%
280
 100.0%
126
 100.0%
676
  98.5%
Not Disclosed
4
   2.6%
0
   0.0%
0
   0.0%
6
   5.8%
0
   0.0%
0
   0.0%
10
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants 10 participants 11 participants 104 participants 280 participants 126 participants 686 participants
China 130 0 0 69 64 126 389
Hong Kong 0 10 11 10 0 0 31
South Korea 0 0 0 0 129 0 129
Taiwan 0 0 0 0 87 0 87
Vietnam 25 0 0 25 0 0 50
HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 10 participants 11 participants 104 participants 280 participants 126 participants 686 participants
Genotype 1
108
  69.7%
7
  70.0%
7
  63.6%
81
  77.9%
0
   0.0%
0
   0.0%
203
  29.6%
Genotype 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
280
 100.0%
0
   0.0%
280
  40.8%
Genotype 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
126
 100.0%
126
  18.4%
Genotype 6
47
  30.3%
3
  30.0%
4
  36.4%
23
  22.1%
0
   0.0%
0
   0.0%
77
  11.2%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 10 participants 11 participants 104 participants 280 participants 126 participants 686 participants
CC
114
  73.5%
8
  80.0%
11
 100.0%
74
  71.2%
237
  84.6%
102
  81.0%
546
  79.6%
CT
40
  25.8%
2
  20.0%
0
   0.0%
29
  27.9%
42
  15.0%
23
  18.3%
136
  19.8%
TT
1
   0.6%
0
   0.0%
0
   0.0%
1
   1.0%
1
   0.4%
1
   0.8%
4
   0.6%
[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 155 participants 10 participants 11 participants 104 participants 280 participants 126 participants 686 participants
6.5  (0.74) 6.3  (0.49) 6.2  (0.88) 6.5  (0.71) 6.2  (0.96) 6.2  (0.71) 6.3  (0.84)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 10 participants 11 participants 104 participants 280 participants 126 participants 686 participants
< 800,000 IU/mL
21
  13.5%
2
  20.0%
6
  54.5%
22
  21.2%
87
  31.1%
32
  25.4%
170
  24.8%
≥ 800,000 IU/mL
134
  86.5%
8
  80.0%
5
  45.5%
82
  78.8%
193
  68.9%
94
  74.6%
516
  75.2%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 is defined as HCV RNA < the lower limit of quantification (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 who enrolled in the study and received at least one dose of study drug.
Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3)
Hide Arm/Group Description:
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 155 10 11 104 280 126
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.5
(90.9 to 98.2)
100
(69.2 to 100)
100
(71.5 to 100)
94.2
(87.9 to 97.9)
96.8
(94.0 to 98.5)
95.2
(89.9 to 98.2)
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
Arm/Group Title SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
Hide Arm/Group Description:
Participants with genotype (GT) 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 155 290 11 230
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.6%
1
   0.3%
0
   0.0%
2
   0.9%
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Hide Description SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Time Frame Posttreatment Weeks 4 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3)
Hide Arm/Group Description:
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 155 10 11 104 280 126
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SVR4
96.8
(92.6 to 98.9)
100
(69.2 to 100.0)
100
(71.5 to 100.0)
94.2
(87.9 to 97.9)
97.5
(94.9 to 99.0)
97.6
(93.2 to 99.5)
SVR24
95.5
(90.9 to 98.2)
100
(69.2 to 100.0)
90.9
(58.7 to 99.8)
94.2
(87.9 to 97.9)
96.8
(94.0 to 98.5)
95.2
(89.9 to 98.2)
4.Secondary Outcome
Title Percentage of Participants With On-Treatment Virologic Failure
Hide Description Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3)
Hide Arm/Group Description:
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 155 10 11 104 280 126
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
0
   0.0%
5.Secondary Outcome
Title Percentage of Participants With Viral Relapse
Hide Description Viral relapse was defined as 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3)
Hide Arm/Group Description:
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 155 10 11 104 280 126
Measure Type: Count of Participants
Unit of Measure: Participants
7
   4.5%
0
   0.0%
0
   0.0%
6
   5.8%
6
   2.1%
6
   4.8%
6.Secondary Outcome
Title Change From Baseline in HCV RNA (log10 IU/mL)
Hide Description [Not Specified]
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed
Arm/Group Title SOF+PEG+RBV 12 Weeks (GT 1 and GT6) SOF+RBV 12 Weeks (GT1 and GT6) SOF+RBV 16 Weeks (GT1 and GT6) SOF+RBV 24 Weeks (GT1 and GT6) SOF+RBV 12 Weeks (GT2) SOF+RBV 24 Weeks (GT3)
Hide Arm/Group Description:
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 155 10 11 104 280 126
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 1 Number Analyzed 155 participants 10 participants 11 participants 104 participants 278 participants 125 participants
-4.81  (0.653) -4.59  (0.359) -4.36  (0.560) -4.61  (0.607) -4.46  (0.815) -4.52  (0.695)
Change at Week 2 Number Analyzed 154 participants 10 participants 11 participants 103 participants 280 participants 126 participants
-5.11  (0.734) -4.89  (0.488) -4.79  (0.858) -5.04  (0.682) -4.78  (1.008) -4.86  (0.706)
Change at Week 4 Number Analyzed 155 participants 10 participants 11 participants 104 participants 280 participants 126 participants
-5.12  (0.738) -4.89  (0.488) -4.82  (0.880) -5.12  (0.710) -4.81  (1.025) -4.87  (0.713)
Change at Week 6 Number Analyzed 155 participants 10 participants 11 participants 104 participants 280 participants 126 participants
-5.12  (0.738) -4.89  (0.488) -4.82  (0.880) -5.12  (0.710) -4.80  (1.038) -4.87  (0.713)
Change at Week 8 Number Analyzed 155 participants 10 participants 11 participants 103 participants 279 participants 126 participants
-5.12  (0.738) -4.89  (0.488) -4.82  (0.880) -5.12  (0.708) -4.83  (0.966) -4.87  (0.713)
Change at Week 10 Number Analyzed 155 participants 10 participants 11 participants 103 participants 279 participants 126 participants
-5.12  (0.738) -4.89  (0.488) -4.82  (0.880) -5.12  (0.708) -4.83  (0.966) -4.87  (0.713)
Change at Week 12 Number Analyzed 154 participants 10 participants 11 participants 103 participants 278 participants 126 participants
-5.12  (0.739) -4.89  (0.488) -4.82  (0.880) -5.12  (0.708) -4.83  (0.966) -4.84  (0.779)
Change at Week 16 Number Analyzed 0 participants 0 participants 11 participants 103 participants 0 participants 126 participants
-4.82  (0.880) -5.12  (0.708) -4.87  (0.713)
Change at Week 20 Number Analyzed 0 participants 0 participants 0 participants 102 participants 0 participants 126 participants
-5.14  (0.701) -4.87  (0.713)
Change at Week 24 Number Analyzed 0 participants 0 participants 0 participants 102 participants 0 participants 126 participants
-5.14  (0.701) -4.87  (0.713)
Time Frame Up to 24 Weeks Plus 30 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
Hide Arm/Group Description Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
All-Cause Mortality
SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/155 (3.23%)   7/290 (2.41%)   0/11 (0.00%)   4/230 (1.74%) 
Eye disorders         
Angle closure glaucoma  1  1/155 (0.65%)  0/290 (0.00%)  0/11 (0.00%)  0/230 (0.00%) 
Gastrointestinal disorders         
Colitis ischaemic  1  0/155 (0.00%)  1/290 (0.34%)  0/11 (0.00%)  0/230 (0.00%) 
Gastritis  1  1/155 (0.65%)  0/290 (0.00%)  0/11 (0.00%)  0/230 (0.00%) 
Gingival bleeding  1  0/155 (0.00%)  0/290 (0.00%)  0/11 (0.00%)  1/230 (0.43%) 
Pancreatitis  1  0/155 (0.00%)  0/290 (0.00%)  0/11 (0.00%)  1/230 (0.43%) 
Vomiting  1  0/155 (0.00%)  1/290 (0.34%)  0/11 (0.00%)  0/230 (0.00%) 
Hepatobiliary disorders         
Biliary colic  1  0/155 (0.00%)  1/290 (0.34%)  0/11 (0.00%)  0/230 (0.00%) 
Cholecystitis acute  1  0/155 (0.00%)  1/290 (0.34%)  0/11 (0.00%)  1/230 (0.43%) 
Cholelithiasis  1  0/155 (0.00%)  0/290 (0.00%)  0/11 (0.00%)  1/230 (0.43%) 
Hepatic lesion  1  0/155 (0.00%)  0/290 (0.00%)  0/11 (0.00%)  1/230 (0.43%) 
Infections and infestations         
Bronchitis  1  1/155 (0.65%)  0/290 (0.00%)  0/11 (0.00%)  0/230 (0.00%) 
Injury, poisoning and procedural complications         
Back injury  1  0/155 (0.00%)  1/290 (0.34%)  0/11 (0.00%)  0/230 (0.00%) 
Concussion  1  0/155 (0.00%)  1/290 (0.34%)  0/11 (0.00%)  0/230 (0.00%) 
Metabolism and nutrition disorders         
Hypocalcaemia  1  1/155 (0.65%)  0/290 (0.00%)  0/11 (0.00%)  0/230 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Fibroadenoma of breast  1  0/155 (0.00%)  0/290 (0.00%)  0/11 (0.00%)  1/230 (0.43%) 
Lung neoplasm malignant  1  0/155 (0.00%)  1/290 (0.34%)  0/11 (0.00%)  0/230 (0.00%) 
Nervous system disorders         
Cerebellar infarction  1  0/155 (0.00%)  1/290 (0.34%)  0/11 (0.00%)  0/230 (0.00%) 
Cerebral haemorrhage  1  0/155 (0.00%)  1/290 (0.34%)  0/11 (0.00%)  0/230 (0.00%) 
Cerebral infarction  1  1/155 (0.65%)  0/290 (0.00%)  0/11 (0.00%)  0/230 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SOF+PEG+RBV 12 Weeks SOF+RBV 12 Weeks SOF+RBV 16 Weeks SOF+RBV 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   145/155 (93.55%)   215/290 (74.14%)   5/11 (45.45%)   177/230 (76.96%) 
Blood and lymphatic system disorders         
Anaemia  1  30/155 (19.35%)  22/290 (7.59%)  1/11 (9.09%)  27/230 (11.74%) 
Leukopenia  1  30/155 (19.35%)  2/290 (0.69%)  0/11 (0.00%)  6/230 (2.61%) 
Neutropenia  1  27/155 (17.42%)  0/290 (0.00%)  0/11 (0.00%)  3/230 (1.30%) 
Thrombocytopenia  1  20/155 (12.90%)  0/290 (0.00%)  0/11 (0.00%)  3/230 (1.30%) 
Gastrointestinal disorders         
Abdominal pain upper  1  1/155 (0.65%)  5/290 (1.72%)  1/11 (9.09%)  4/230 (1.74%) 
Constipation  1  1/155 (0.65%)  2/290 (0.69%)  1/11 (9.09%)  7/230 (3.04%) 
Diarrhoea  1  3/155 (1.94%)  7/290 (2.41%)  1/11 (9.09%)  3/230 (1.30%) 
Dyspepsia  1  1/155 (0.65%)  8/290 (2.76%)  1/11 (9.09%)  0/230 (0.00%) 
Gastrooesophageal reflux disease  1  1/155 (0.65%)  4/290 (1.38%)  1/11 (9.09%)  0/230 (0.00%) 
Gingival pain  1  0/155 (0.00%)  1/290 (0.34%)  1/11 (9.09%)  0/230 (0.00%) 
Nausea  1  10/155 (6.45%)  14/290 (4.83%)  0/11 (0.00%)  2/230 (0.87%) 
Vomiting  1  6/155 (3.87%)  8/290 (2.76%)  1/11 (9.09%)  1/230 (0.43%) 
General disorders         
Asthenia  1  21/155 (13.55%)  8/290 (2.76%)  0/11 (0.00%)  9/230 (3.91%) 
Fatigue  1  24/155 (15.48%)  21/290 (7.24%)  0/11 (0.00%)  20/230 (8.70%) 
Malaise  1  0/155 (0.00%)  3/290 (1.03%)  2/11 (18.18%)  1/230 (0.43%) 
Non-cardiac chest pain  1  8/155 (5.16%)  0/290 (0.00%)  0/11 (0.00%)  4/230 (1.74%) 
Pain  1  9/155 (5.81%)  0/290 (0.00%)  0/11 (0.00%)  5/230 (2.17%) 
Pyrexia  1  56/155 (36.13%)  4/290 (1.38%)  0/11 (0.00%)  10/230 (4.35%) 
Infections and infestations         
Nasopharyngitis  1  6/155 (3.87%)  21/290 (7.24%)  0/11 (0.00%)  6/230 (2.61%) 
Upper respiratory tract infection  1  11/155 (7.10%)  30/290 (10.34%)  2/11 (18.18%)  27/230 (11.74%) 
Investigations         
Alanine aminotransferase increased  1  10/155 (6.45%)  0/290 (0.00%)  0/11 (0.00%)  6/230 (2.61%) 
Blood bilirubin increased  1  7/155 (4.52%)  7/290 (2.41%)  0/11 (0.00%)  34/230 (14.78%) 
Haemoglobin decreased  1  23/155 (14.84%)  9/290 (3.10%)  0/11 (0.00%)  20/230 (8.70%) 
Neutrophil count decreased  1  38/155 (24.52%)  1/290 (0.34%)  0/11 (0.00%)  1/230 (0.43%) 
Platelet count decreased  1  37/155 (23.87%)  1/290 (0.34%)  0/11 (0.00%)  2/230 (0.87%) 
Red blood cell count decreased  1  11/155 (7.10%)  6/290 (2.07%)  0/11 (0.00%)  16/230 (6.96%) 
Reticulocyte count increased  1  13/155 (8.39%)  15/290 (5.17%)  0/11 (0.00%)  35/230 (15.22%) 
White blood cell count decreased  1  33/155 (21.29%)  1/290 (0.34%)  0/11 (0.00%)  0/230 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  9/155 (5.81%)  4/290 (1.38%)  0/11 (0.00%)  7/230 (3.04%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  20/155 (12.90%)  14/290 (4.83%)  0/11 (0.00%)  1/230 (0.43%) 
Nervous system disorders         
Dizziness  1  14/155 (9.03%)  17/290 (5.86%)  0/11 (0.00%)  11/230 (4.78%) 
Headache  1  24/155 (15.48%)  34/290 (11.72%)  0/11 (0.00%)  14/230 (6.09%) 
Psychiatric disorders         
Insomnia  1  6/155 (3.87%)  29/290 (10.00%)  0/11 (0.00%)  26/230 (11.30%) 
Irritability  1  1/155 (0.65%)  1/290 (0.34%)  1/11 (9.09%)  1/230 (0.43%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  16/155 (10.32%)  18/290 (6.21%)  0/11 (0.00%)  14/230 (6.09%) 
Oropharyngeal pain  1  9/155 (5.81%)  7/290 (2.41%)  0/11 (0.00%)  7/230 (3.04%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  2/155 (1.29%)  33/290 (11.38%)  0/11 (0.00%)  8/230 (3.48%) 
Rash  1  11/155 (7.10%)  18/290 (6.21%)  0/11 (0.00%)  10/230 (4.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
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
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: NCT02021643    
Other Study ID Numbers: GS-US-334-0115
First Submitted: November 26, 2013
First Posted: December 27, 2013
Results First Submitted: August 11, 2017
Results First Posted: February 20, 2018
Last Update Posted: February 20, 2018