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Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

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ClinicalTrials.gov Identifier: NCT01667731
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : November 21, 2014
Last Update Posted : November 21, 2014
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
Conditions Hepatitis C
Human Immunodeficiency Virus
Interventions Drug: SOF
Drug: RBV
Enrollment 224
Recruitment Details Participants were enrolled at a total of 34 study sites in the United States. The first participant was screened on 20 July 2012. The last participant observation occurred on 10 February 2014.
Pre-assignment Details 330 participants were screened.
Arm/Group Title SOF+RBV 12 Wk GT 2 TN SOF+RBV 12 Wk GT 3 TN SOF+RBV 24 Wk GT 2 TE SOF+RBV 24 Wk GT 3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN), genotype (GT) 2) SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3) SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced (TE), genotype 2) SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3) SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Period Title: Overall Study
Started 26 42 24 17 115
Completed 21 26 22 15 87
Not Completed 5 16 2 2 28
Reason Not Completed
Enrolled but not treated             0             0             0             0             1
Efficacy Failure             1             12             0             1             24
Lost to Follow-up             2             3             1             1             2
Subject Withdrew Consent             2             0             1             0             1
Death             0             1             0             0             0
Arm/Group Title SOF+RBV 12 Wk GT 2 TN SOF+RBV 12 Wk GT 3 TN SOF+RBV 24 Wk GT 2 TE SOF+RBV 24 Wk GT 3 TE SOF+RBV 24 Wk GT 1 TN Total
Hide Arm/Group Description SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2) SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3) SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2) SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3) SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1) Total of all reporting groups
Overall Number of Baseline Participants 26 42 24 17 114 223
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 26 participants 42 participants 24 participants 17 participants 114 participants 223 participants
51  (9.7) 48  (9.6) 54  (4.9) 54  (7.0) 48  (8.4) 49  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 42 participants 24 participants 17 participants 114 participants 223 participants
Female
5
  19.2%
8
  19.0%
1
   4.2%
3
  17.6%
21
  18.4%
38
  17.0%
Male
21
  80.8%
34
  81.0%
23
  95.8%
14
  82.4%
93
  81.6%
185
  83.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 42 participants 24 participants 17 participants 114 participants 223 participants
Hispanic or Latino
8
  30.8%
11
  26.2%
5
  20.8%
5
  29.4%
25
  21.9%
54
  24.2%
Not Hispanic or Latino
18
  69.2%
31
  73.8%
19
  79.2%
12
  70.6%
89
  78.1%
169
  75.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 42 participants 24 participants 17 participants 114 participants 223 participants
Black or African American 6 2 6 1 37 52
White 18 36 17 15 70 156
Asian 0 1 1 0 1 3
American Indian/Alaska Native/First Nations 0 0 0 1 0 1
Hawaiian or Other Pacific Islander 1 0 0 0 1 2
Other 1 3 0 0 5 9
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 42 participants 24 participants 17 participants 114 participants 223 participants
Genotype 1 0 0 0 0 114 114
Genotype 2 26 0 24 0 0 50
Genotype 3 0 42 0 17 0 59
Liver Cirrhosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 42 participants 24 participants 17 participants 114 participants 223 participants
No 25 36 20 11 109 201
Yes 1 6 4 6 5 22
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 42 participants 24 participants 17 participants 114 participants 223 participants
CC 10 15 10 10 30 75
CT 15 22 10 7 57 111
TT 1 5 4 0 26 36
Missing 0 0 0 0 1 1
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
HCV RNA (log10 IU/mL)  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 26 participants 42 participants 24 participants 17 participants 114 participants 223 participants
6.5  (0.59) 6.2  (0.59) 6.5  (0.82) 6.4  (0.47) 6.6  (0.83) 6.5  (0.75)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 42 participants 24 participants 17 participants 114 participants 223 participants
< 6 log10 IU/mL 6 15 5 2 22 50
≥ 6 log10 IU/mL 20 27 19 15 92 173
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) at 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
Show Outcome Measure DataHide 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 Wk GT 2 TN SOF+RBV 12 Wk GT 3 TN SOF+RBV 24 Wk GT 2 TE SOF+RBV 24 Wk GT 3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description:
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Overall Number of Participants Analyzed 26 42 24 17 114
Measure Type: Number
Unit of Measure: percentage of participants
88.5 66.7 91.7 94.1 76.3
2.Primary Outcome
Title Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Hide Description The percentage of participants discontinuing any study drug due to an adverse event was summarized.
Time Frame Up to 24 weeks
Show Outcome Measure DataHide 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 Wk GT 2/3 TN SOF+RBV 24 Wk GT 2/3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description:
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Overall Number of Participants Analyzed 68 41 114
Measure Type: Number
Unit of Measure: percentage of participants
4.4 2.4 2.6
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Hide Description SVR4 and SVR24 were 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+RBV 12 Wk GT 2 TN SOF+RBV 12 Wk GT 3 TN SOF+RBV 24 Wk GT 2 TE SOF+RBV 24 Wk GT 3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description:
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Overall Number of Participants Analyzed 26 42 24 17 114
Measure Type: Number
Unit of Measure: percentage of participants
SVR4 88.5 71.4 95.8 94.1 80.7
SVR24 88.5 66.7 91.7 88.2 75.4
4.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 1
Hide Description [Not Specified]
Time Frame Baseline; Week 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF+RBV 12 Wk GT 2 TN SOF+RBV 12 Wk GT 3 TN SOF+RBV 24 Wk GT 2 TE SOF+RBV 24 Wk GT 3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description:
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Overall Number of Participants Analyzed 25 40 24 16 108
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.69  (0.471) -4.52  (0.464) -4.63  (0.680) -4.78  (0.354) -4.42  (0.958)
5.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 2
Hide Description [Not Specified]
Time Frame Baseline; Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF+RBV 12 Wk GT 2 TN SOF+RBV 12 Wk GT 3 TN SOF+RBV 24 Wk GT 2 TE SOF+RBV 24 Wk GT 3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description:
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Overall Number of Participants Analyzed 26 41 24 17 112
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.11  (0.574) -4.84  (0.579) -5.15  (0.813) -5.06  (0.467) -5.00  (0.829)
6.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 4
Hide Description [Not Specified]
Time Frame Baseline; Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF+RBV 12 Wk GT 2 TN SOF+RBV 12 Wk GT 3 TN SOF+RBV 24 Wk GT 2 TE SOF+RBV 24 Wk GT 3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description:
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Overall Number of Participants Analyzed 26 41 24 17 114
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.04  (0.710) -4.86  (0.602) -5.16  (0.820) -5.06  (0.467) -5.12  (0.957)
7.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 6
Hide Description [Not Specified]
Time Frame Baseline; Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF+RBV 12 Wk GT 2 TN SOF+RBV 12 Wk GT 3 TN SOF+RBV 24 Wk GT 2 TE SOF+RBV 24 Wk GT 3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description:
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Overall Number of Participants Analyzed 26 41 24 17 110
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.13  (0.593) -4.86  (0.602) -5.16  (0.820) -5.06  (0.467) -5.20  (0.785)
8.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 8
Hide Description [Not Specified]
Time Frame Baseline; Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF+RBV 12 Wk GT 2 TN SOF+RBV 12 Wk GT 3 TN SOF+RBV 24 Wk GT 2 TE SOF+RBV 24 Wk GT 3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description:
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Overall Number of Participants Analyzed 26 40 24 17 111
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.13  (0.593) -4.83  (0.589) -5.16  (0.820) -5.06  (0.467) -5.20  (0.785)
9.Secondary Outcome
Title Percentage of Participants Experiencing On-treatment Virologic Failure
Hide Description

On-treatment virologic failure was defined as:

  1. Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
  2. Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
  3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
Time Frame Up to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+RBV 12 Wk GT 2 TN SOF+RBV 12 Wk GT 3 TN SOF+RBV 24 Wk GT 2 TE SOF+RBV 24 Wk GT 3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description:
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Overall Number of Participants Analyzed 26 42 24 17 114
Measure Type: Number
Unit of Measure: percentage of participants
3.8 0 0 0 0.9
10.Secondary Outcome
Title Percentage of Participants Experiencing Viral Relapse
Hide Description Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
Time Frame Up to Posttreatment Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF+RBV 12 Wk GT 2 TN SOF+RBV 12 Wk GT 3 TN SOF+RBV 24 Wk GT 2 TE SOF+RBV 24 Wk GT 3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description:
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
Overall Number of Participants Analyzed 25 42 24 17 113
Measure Type: Number
Unit of Measure: percentage of participants
0 28.6 4.2 5.9 22.1
Time Frame Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title SOF+RBV 12 Wk GT 2/3 TN SOF+RBV 24 Wk GT 2/3 TE SOF+RBV 24 Wk GT 1 TN
Hide Arm/Group Description SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3) SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3) SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
All-Cause Mortality
SOF+RBV 12 Wk GT 2/3 TN SOF+RBV 24 Wk GT 2/3 TE SOF+RBV 24 Wk GT 1 TN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SOF+RBV 12 Wk GT 2/3 TN SOF+RBV 24 Wk GT 2/3 TE SOF+RBV 24 Wk GT 1 TN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/68 (7.35%)   1/41 (2.44%)   8/114 (7.02%) 
Blood and lymphatic system disorders       
Anaemia  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Leukocytosis  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Cardiac disorders       
Atrial fibrillation  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Atrial flutter  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Acute myocardial infarction  1  1/68 (1.47%)  0/41 (0.00%)  0/114 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Colitis  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Enteritis  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
General disorders       
Chest pain  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Infections and infestations       
Cellulitis  1  0/68 (0.00%)  0/41 (0.00%)  2/114 (1.75%) 
Pneumonia  1  1/68 (1.47%)  1/41 (2.44%)  0/114 (0.00%) 
Gastroenteritis salmonella  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Respiratory tract infection  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Incision site infection  1  1/68 (1.47%)  0/41 (0.00%)  0/114 (0.00%) 
Septic shock  1  1/68 (1.47%)  0/41 (0.00%)  0/114 (0.00%) 
Staphylococcal bacteraemia  1  1/68 (1.47%)  0/41 (0.00%)  0/114 (0.00%) 
Injury, poisoning and procedural complications       
Intentional overdose  1  1/68 (1.47%)  0/41 (0.00%)  1/114 (0.88%) 
Fracture  1  1/68 (1.47%)  0/41 (0.00%)  0/114 (0.00%) 
Metabolism and nutrition disorders       
Diabetic ketoacidosis  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Nervous system disorders       
Altered state of consciousness  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Encephalopathy  1  1/68 (1.47%)  0/41 (0.00%)  0/114 (0.00%) 
Psychiatric disorders       
Bipolar disorder  1  0/68 (0.00%)  0/41 (0.00%)  1/114 (0.88%) 
Completed suicide  1  1/68 (1.47%)  0/41 (0.00%)  0/114 (0.00%) 
Drug abuse  1  1/68 (1.47%)  0/41 (0.00%)  0/114 (0.00%) 
Suicide attempt  1  1/68 (1.47%)  0/41 (0.00%)  0/114 (0.00%) 
Renal and urinary disorders       
Renal failure acute  1  1/68 (1.47%)  0/41 (0.00%)  2/114 (1.75%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/68 (0.00%)  1/41 (2.44%)  0/114 (0.00%) 
Pulmonary embolism  1  1/68 (1.47%)  0/41 (0.00%)  0/114 (0.00%) 
Respiratory failure  1  1/68 (1.47%)  0/41 (0.00%)  0/114 (0.00%) 
Skin and subcutaneous tissue disorders       
Leukocytoclastic vasculitis  1  0/68 (0.00%)  1/41 (2.44%)  0/114 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SOF+RBV 12 Wk GT 2/3 TN SOF+RBV 24 Wk GT 2/3 TE SOF+RBV 24 Wk GT 1 TN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   57/68 (83.82%)   37/41 (90.24%)   106/114 (92.98%) 
Blood and lymphatic system disorders       
Anaemia  1  6/68 (8.82%)  3/41 (7.32%)  12/114 (10.53%) 
Gastrointestinal disorders       
Nausea  1  12/68 (17.65%)  6/41 (14.63%)  18/114 (15.79%) 
Diarrhoea  1  6/68 (8.82%)  5/41 (12.20%)  12/114 (10.53%) 
Vomiting  1  4/68 (5.88%)  4/41 (9.76%)  11/114 (9.65%) 
Abdominal pain  1  1/68 (1.47%)  2/41 (4.88%)  6/114 (5.26%) 
Constipation  1  1/68 (1.47%)  1/41 (2.44%)  6/114 (5.26%) 
Abdominal discomfort  1  2/68 (2.94%)  3/41 (7.32%)  2/114 (1.75%) 
Abdominal distension  1  0/68 (0.00%)  0/41 (0.00%)  6/114 (5.26%) 
General disorders       
Fatigue  1  24/68 (35.29%)  19/41 (46.34%)  41/114 (35.96%) 
Irritability  1  7/68 (10.29%)  2/41 (4.88%)  14/114 (12.28%) 
Pyrexia  1  2/68 (2.94%)  3/41 (7.32%)  7/114 (6.14%) 
Infections and infestations       
Upper respiratory tract infection  1  8/68 (11.76%)  5/41 (12.20%)  13/114 (11.40%) 
Bronchitis  1  1/68 (1.47%)  4/41 (9.76%)  11/114 (9.65%) 
Nasopharyngitis  1  3/68 (4.41%)  0/41 (0.00%)  10/114 (8.77%) 
Oral herpes  1  2/68 (2.94%)  3/41 (7.32%)  5/114 (4.39%) 
Herpes simplex  1  4/68 (5.88%)  0/41 (0.00%)  1/114 (0.88%) 
Metabolism and nutrition disorders       
Decreased appetite  1  3/68 (4.41%)  2/41 (4.88%)  7/114 (6.14%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/68 (0.00%)  2/41 (4.88%)  6/114 (5.26%) 
Arthralgia  1  1/68 (1.47%)  0/41 (0.00%)  7/114 (6.14%) 
Nervous system disorders       
Headache  1  9/68 (13.24%)  5/41 (12.20%)  16/114 (14.04%) 
Dizziness  1  1/68 (1.47%)  4/41 (9.76%)  7/114 (6.14%) 
Psychiatric disorders       
Insomnia  1  14/68 (20.59%)  8/41 (19.51%)  15/114 (13.16%) 
Depression  1  6/68 (8.82%)  1/41 (2.44%)  8/114 (7.02%) 
Anxiety  1  2/68 (2.94%)  0/41 (0.00%)  8/114 (7.02%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  4/68 (5.88%)  4/41 (9.76%)  14/114 (12.28%) 
Dyspnoea  1  1/68 (1.47%)  2/41 (4.88%)  9/114 (7.89%) 
Nasal congestion  1  1/68 (1.47%)  2/41 (4.88%)  8/114 (7.02%) 
Respiratory tract congestion  1  1/68 (1.47%)  3/41 (7.32%)  1/114 (0.88%) 
Sinus congestion  1  1/68 (1.47%)  3/41 (7.32%)  1/114 (0.88%) 
Skin and subcutaneous tissue disorders       
Rash  1  3/68 (4.41%)  4/41 (9.76%)  7/114 (6.14%) 
Pruritus  1  6/68 (8.82%)  2/41 (4.88%)  6/114 (5.26%) 
Dry skin  1  2/68 (2.94%)  0/41 (0.00%)  6/114 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16.1
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: NCT01667731     History of Changes
Other Study ID Numbers: GS-US-334-0123
First Submitted: August 9, 2012
First Posted: August 17, 2012
Results First Submitted: November 14, 2014
Results First Posted: November 21, 2014
Last Update Posted: November 21, 2014