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SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection

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ClinicalTrials.gov Identifier: NCT01962441
Recruitment Status : Completed
First Posted : October 14, 2013
Results First Posted : February 5, 2016
Last Update Posted : June 20, 2017
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 Hepatitis C
Interventions Drug: SOF
Drug: RBV
Drug: Peg-IFN
Enrollment 601
Recruitment Details Participants were enrolled at study sites in Europe, North America, Australia, and New Zealand. The first participant was screened on 24 September 2013. The last study visit occurred on 07 July 2016.
Pre-assignment Details 776 participants were screened.
Arm/Group Title SOF+RBV 16 Weeks, Then Retreatment SOF+RBV 24 Weeks, Then Retreatment SOF+RBV+Peg-IFN 12 Weeks
Hide Arm/Group Description

Randomized Period: Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks

Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks.

Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks

Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks.

Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks

Participants in this group were not eligible to enroll into the Retreatment Period.

Period Title: Randomized Period
Started 200 201 200
Completed 190 190 189
Not Completed 10 11 11
Reason Not Completed
Randomized but Never Treated             4             2             3
Lost to Follow-up             2             4             4
Withdrew Consent             3             3             2
Adverse Event             1             1             0
Death             0             0             2
Protocol Violation             0             1             0
Period Title: Retreatment Substudy
Started 20 [1] 10 [2] 0 [3]
Completed 18 10 0
Not Completed 2 0 0
Reason Not Completed
Lack of Efficacy             1             0             0
Lost to Follow-up             1             0             0
[1]
20 participants who experienced virologic failure enrolled into the Retreatment Substudy.
[2]
10 participants who experienced virologic failure enrolled into the Retreatment Substudy.
[3]
Participants in the SOF+RBV+Peg-IFN group were not eligible to enroll in the Retreatment Substudy.
Arm/Group Title SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks Total
Hide Arm/Group Description SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 196 199 197 592
Hide Baseline Analysis Population Description
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 196 participants 199 participants 197 participants 592 participants
51  (9.7) 49  (9.8) 50  (10.2) 50  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 196 participants 199 participants 197 participants 592 participants
Female
62
  31.6%
70
  35.2%
65
  33.0%
197
  33.3%
Male
134
  68.4%
129
  64.8%
132
  67.0%
395
  66.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 196 participants 199 participants 197 participants 592 participants
Hispanic or Latino 5 5 2 12
Not Hispanic or Latino 188 188 191 567
Not Disclosed 3 6 4 13
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 196 participants 199 participants 197 participants 592 participants
Black or African American 2 2 2 6
White 162 168 165 495
Asian 29 26 25 80
American Indian/ Alaska Native/ First Nations 2 0 0 2
Hawaiian or Pacific Islander 0 1 2 3
Other 0 1 1 2
Not Disclosed 1 1 2 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 196 participants 199 participants 197 participants 592 participants
New Zealand 15 12 13 40
Canada 21 33 29 83
United States 29 33 31 93
United Kingdom 86 82 80 248
Australia 45 39 44 128
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 196 participants 199 participants 197 participants 592 participants
Genotype 2 15 17 16 48
Genotype 3 181 182 181 544
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 196 participants 199 participants 197 participants 592 participants
CC 75 73 78 226
CT 94 95 98 287
TT 27 31 21 79
[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 196 participants 199 participants 197 participants 592 participants
6.3  (0.68) 6.2  (0.71) 6.3  (0.69) 6.3  (0.69)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 196 participants 199 participants 197 participants 592 participants
< 6 log10 IU/mL 60 72 60 192
≥ 6 log10 IU/mL 136 127 137 400
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, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
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Hide Analysis Population Description
Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.
Arm/Group Title SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Hide Arm/Group Description:
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
Overall Number of Participants Analyzed 196 199 197
Measure Type: Number
Unit of Measure: percentage of participants
71.9 85.4 92.9
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 with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.
Arm/Group Title SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Hide Arm/Group Description:
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
Overall Number of Participants Analyzed 196 199 197
Measure Type: Number
Unit of Measure: percentage of participants
1.5 1.5 1.5
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 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Hide Arm/Group Description:
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
Overall Number of Participants Analyzed 196 199 197
Measure Type: Number
Unit of Measure: percentage of participants
SVR4 73.0 85.9 95.9
SVR24 71.9 84.4 93.4
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 8, 12, 16, 20, 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 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Hide Arm/Group Description:
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
Overall Number of Participants Analyzed 196 199 197
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 196 participants 199 participants 197 participants
14.8 20.1 25.9
Week 2 Number Analyzed 195 participants 198 participants 197 participants
53.3 53.5 67.0
Week 4 Number Analyzed 194 participants 198 participants 195 participants
86.6 91.9 97.4
Week 8 Number Analyzed 193 participants 198 participants 195 participants
99.5 99.5 99.5
Week 12 Number Analyzed 190 participants 197 participants 194 participants
100.0 98.5 100.0
Week 16 Number Analyzed 191 participants 194 participants 0 participants
99.0 99.5
Week 20 Number Analyzed 0 participants 194 participants 0 participants
99.5
Week 24 Number Analyzed 0 participants 193 participants 0 participants
100.0
5.Secondary Outcome
Title HCV RNA at Weeks 1, 2, 4, 8, and 12
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 8, and 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 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Hide Arm/Group Description:
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
Overall Number of Participants Analyzed 194 198 195
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Week 1 Number Analyzed 194 participants 197 participants 194 participants
2.13  (0.658) 2.08  (0.749) 1.81  (0.576)
Week 2 Number Analyzed 191 participants 196 participants 195 participants
1.44  (0.436) 1.45  (0.487) 1.32  (0.342)
Week 4 Number Analyzed 193 participants 198 participants 195 participants
1.19  (0.156) 1.21  (0.287) 1.16  (0.085)
Week 8 Number Analyzed 193 participants 198 participants 194 participants
1.15  (0.021) 1.15  (0.100) 1.15  (0.000)
Week 12 Number Analyzed 191 participants 197 participants 194 participants
1.15  (0.000) 1.17  (0.318) 1.15  (0.000)
6.Secondary Outcome
Title Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 8, and 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 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Hide Arm/Group Description:
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
Overall Number of Participants Analyzed 194 198 195
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Week 1 Number Analyzed 194 participants 197 participants 194 participants
-4.18  (0.559) -4.15  (0.664) -4.46  (0.556)
Week 2 Number Analyzed 191 participants 196 participants 195 participants
-4.86  (0.661) -4.78  (0.714) -4.96  (0.661)
Week 4 Number Analyzed 193 participants 198 participants 195 participants
-5.11  (0.671) -5.02  (0.735) -5.12  (0.699)
Week 8 Number Analyzed 193 participants 198 participants 194 participants
-5.16  (0.684) -5.08  (0.708) -5.12  (0.691)
Week 12 Number Analyzed 191 participants 197 participants 194 participants
-5.15  (0.686) -5.05  (0.788) -5.12  (0.691)
7.Secondary Outcome
Title Percentage of Participants Experiencing 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
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Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Hide Arm/Group Description:
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
Overall Number of Participants Analyzed 196 199 197
Measure Type: Number
Unit of Measure: percentage of participants
0 1.5 0
8.Secondary Outcome
Title Percentage of Participants Experiencing Viral Relapse
Hide Description Viral relapse is 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
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF+RBV 16 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
Hide Arm/Group Description:
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
Overall Number of Participants Analyzed 195 195 195
Measure Type: Number
Unit of Measure: percentage of participants
26.7 12.3 4.6
Time Frame Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Adverse Event Reporting Description

Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.

MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period

 
Arm/Group Title Randomized Period: SOF+RBV 16 Weeks Randomized Period: SOF+RBV 24 Weeks Randomized Period: SOF+RBV+Peg-IFN 12 Weeks Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks
Hide Arm/Group Description Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks Retreatment Period: Participants from the SOF+RBV 16 Weeks or 24 Weeks groups who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks.
All-Cause Mortality
Randomized Period: SOF+RBV 16 Weeks Randomized Period: SOF+RBV 24 Weeks Randomized Period: SOF+RBV+Peg-IFN 12 Weeks Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/196 (0.00%)   0/199 (0.00%)   0/197 (0.00%)   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Randomized Period: SOF+RBV 16 Weeks Randomized Period: SOF+RBV 24 Weeks Randomized Period: SOF+RBV+Peg-IFN 12 Weeks Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/196 (4.08%)   10/199 (5.03%)   12/197 (6.09%)   1/30 (3.33%) 
Cardiac disorders         
Acute coronary syndrome  1  1/196 (0.51%)  0/199 (0.00%)  0/197 (0.00%)  0/30 (0.00%) 
Atrial fibrillation  1  0/196 (0.00%)  1/199 (0.50%)  1/197 (0.51%)  0/30 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  0/196 (0.00%)  1/199 (0.50%)  0/197 (0.00%)  0/30 (0.00%) 
Nausea  1  0/196 (0.00%)  0/199 (0.00%)  1/197 (0.51%)  0/30 (0.00%) 
Pancreatitis  1  1/196 (0.51%)  1/199 (0.50%)  0/197 (0.00%)  0/30 (0.00%) 
Vomiting  1  0/196 (0.00%)  0/199 (0.00%)  1/197 (0.51%)  0/30 (0.00%) 
General disorders         
Chest pain  1  1/196 (0.51%)  0/199 (0.00%)  0/197 (0.00%)  0/30 (0.00%) 
Infections and infestations         
Cellulitis  1  1/196 (0.51%)  0/199 (0.00%)  0/197 (0.00%)  0/30 (0.00%) 
Pneumonia  1  0/196 (0.00%)  0/199 (0.00%)  1/197 (0.51%)  0/30 (0.00%) 
Respiratory tract infection  1  0/196 (0.00%)  0/199 (0.00%)  1/197 (0.51%)  0/30 (0.00%) 
Subcutaneous abscess  1  0/196 (0.00%)  1/199 (0.50%)  0/197 (0.00%)  0/30 (0.00%) 
Injury, poisoning and procedural complications         
Overdose  1  0/196 (0.00%)  1/199 (0.50%)  0/197 (0.00%)  0/30 (0.00%) 
Snake bite  1  0/196 (0.00%)  0/199 (0.00%)  1/197 (0.51%)  0/30 (0.00%) 
Investigations         
Haemoglobin decreased  1  0/196 (0.00%)  0/199 (0.00%)  1/197 (0.51%)  0/30 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthritis  1  1/196 (0.51%)  0/199 (0.00%)  0/197 (0.00%)  0/30 (0.00%) 
Flank pain  1  0/196 (0.00%)  1/199 (0.50%)  0/197 (0.00%)  0/30 (0.00%) 
Musculoskeletal chest pain  1  0/196 (0.00%)  1/199 (0.50%)  0/197 (0.00%)  0/30 (0.00%) 
Musculoskeletal pain  1  0/196 (0.00%)  0/199 (0.00%)  0/197 (0.00%)  1/30 (3.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma of colon  1  1/196 (0.51%)  0/199 (0.00%)  0/197 (0.00%)  0/30 (0.00%) 
Hepatocellular carcinoma  1  0/196 (0.00%)  1/199 (0.50%)  0/197 (0.00%)  0/30 (0.00%) 
Nervous system disorders         
Loss of consciousness  1  0/196 (0.00%)  0/199 (0.00%)  1/197 (0.51%)  0/30 (0.00%) 
Syncope  1  0/196 (0.00%)  1/199 (0.50%)  1/197 (0.51%)  0/30 (0.00%) 
Psychiatric disorders         
Alcohol abuse  1  0/196 (0.00%)  1/199 (0.50%)  0/197 (0.00%)  0/30 (0.00%) 
Alcohol withdrawal syndrome  1  0/196 (0.00%)  0/199 (0.00%)  1/197 (0.51%)  0/30 (0.00%) 
Depression  1  1/196 (0.51%)  0/199 (0.00%)  1/197 (0.51%)  0/30 (0.00%) 
Drug abuse  1  0/196 (0.00%)  1/199 (0.50%)  0/197 (0.00%)  0/30 (0.00%) 
Hallucination  1  0/196 (0.00%)  0/199 (0.00%)  1/197 (0.51%)  0/30 (0.00%) 
Suicidal ideation  1  1/196 (0.51%)  0/199 (0.00%)  0/197 (0.00%)  0/30 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pleuritic pain  1  0/196 (0.00%)  0/199 (0.00%)  1/197 (0.51%)  0/30 (0.00%) 
Social circumstances         
Miscarriage of partner  1  0/196 (0.00%)  1/199 (0.50%)  0/197 (0.00%)  0/30 (0.00%) 
Vascular disorders         
Orthostatic hypotension  1  1/196 (0.51%)  0/199 (0.00%)  0/197 (0.00%)  0/30 (0.00%) 
1
Term from vocabulary, MedDRA 18.0 and 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Randomized Period: SOF+RBV 16 Weeks Randomized Period: SOF+RBV 24 Weeks Randomized Period: SOF+RBV+Peg-IFN 12 Weeks Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   173/196 (88.27%)   176/199 (88.44%)   192/197 (97.46%)   29/30 (96.67%) 
Blood and lymphatic system disorders         
Anaemia  1  4/196 (2.04%)  7/199 (3.52%)  12/197 (6.09%)  0/30 (0.00%) 
Neutropenia  1  0/196 (0.00%)  0/199 (0.00%)  11/197 (5.58%)  2/30 (6.67%) 
Eye disorders         
Dry eye  1  3/196 (1.53%)  5/199 (2.51%)  5/197 (2.54%)  2/30 (6.67%) 
Gastrointestinal disorders         
Abdominal pain  1  8/196 (4.08%)  8/199 (4.02%)  11/197 (5.58%)  1/30 (3.33%) 
Abdominal pain upper  1  7/196 (3.57%)  10/199 (5.03%)  9/197 (4.57%)  0/30 (0.00%) 
Diarrhoea  1  21/196 (10.71%)  18/199 (9.05%)  27/197 (13.71%)  3/30 (10.00%) 
Dry mouth  1  3/196 (1.53%)  7/199 (3.52%)  12/197 (6.09%)  0/30 (0.00%) 
Dyspepsia  1  10/196 (5.10%)  12/199 (6.03%)  11/197 (5.58%)  1/30 (3.33%) 
Gastrooesophageal reflux disease  1  4/196 (2.04%)  8/199 (4.02%)  3/197 (1.52%)  2/30 (6.67%) 
Mouth ulceration  1  5/196 (2.55%)  3/199 (1.51%)  5/197 (2.54%)  2/30 (6.67%) 
Nausea  1  32/196 (16.33%)  34/199 (17.09%)  50/197 (25.38%)  7/30 (23.33%) 
Vomiting  1  10/196 (5.10%)  21/199 (10.55%)  19/197 (9.64%)  0/30 (0.00%) 
General disorders         
Asthenia  1  2/196 (1.02%)  3/199 (1.51%)  10/197 (5.08%)  0/30 (0.00%) 
Chills  1  3/196 (1.53%)  4/199 (2.01%)  21/197 (10.66%)  1/30 (3.33%) 
Fatigue  1  74/196 (37.76%)  83/199 (41.71%)  92/197 (46.70%)  18/30 (60.00%) 
Influenza like illness  1  7/196 (3.57%)  8/199 (4.02%)  39/197 (19.80%)  6/30 (20.00%) 
Injection site rash  1  0/196 (0.00%)  0/199 (0.00%)  5/197 (2.54%)  2/30 (6.67%) 
Pyrexia  1  5/196 (2.55%)  7/199 (3.52%)  29/197 (14.72%)  6/30 (20.00%) 
Infections and infestations         
Nasopharyngitis  1  12/196 (6.12%)  14/199 (7.04%)  7/197 (3.55%)  1/30 (3.33%) 
Upper respiratory tract infection  1  8/196 (4.08%)  10/199 (5.03%)  3/197 (1.52%)  0/30 (0.00%) 
Investigations         
Platelet count decreased  1  0/196 (0.00%)  0/199 (0.00%)  3/197 (1.52%)  2/30 (6.67%) 
Metabolism and nutrition disorders         
Decreased appetite  1  13/196 (6.63%)  16/199 (8.04%)  35/197 (17.77%)  3/30 (10.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  10/196 (5.10%)  15/199 (7.54%)  25/197 (12.69%)  3/30 (10.00%) 
Back pain  1  10/196 (5.10%)  14/199 (7.04%)  15/197 (7.61%)  2/30 (6.67%) 
Musculoskeletal pain  1  9/196 (4.59%)  22/199 (11.06%)  11/197 (5.58%)  1/30 (3.33%) 
Myalgia  1  12/196 (6.12%)  19/199 (9.55%)  33/197 (16.75%)  7/30 (23.33%) 
Neck pain  1  2/196 (1.02%)  2/199 (1.01%)  1/197 (0.51%)  2/30 (6.67%) 
Nervous system disorders         
Dizziness  1  11/196 (5.61%)  16/199 (8.04%)  13/197 (6.60%)  2/30 (6.67%) 
Dizziness postural  1  3/196 (1.53%)  1/199 (0.50%)  10/197 (5.08%)  0/30 (0.00%) 
Dysgeusia  1  6/196 (3.06%)  4/199 (2.01%)  10/197 (5.08%)  1/30 (3.33%) 
Headache  1  61/196 (31.12%)  72/199 (36.18%)  70/197 (35.53%)  12/30 (40.00%) 
Lethargy  1  9/196 (4.59%)  8/199 (4.02%)  10/197 (5.08%)  1/30 (3.33%) 
Memory impairment  1  10/196 (5.10%)  3/199 (1.51%)  5/197 (2.54%)  1/30 (3.33%) 
Psychiatric disorders         
Anxiety  1  12/196 (6.12%)  16/199 (8.04%)  17/197 (8.63%)  1/30 (3.33%) 
Depressed mood  1  8/196 (4.08%)  11/199 (5.53%)  17/197 (8.63%)  0/30 (0.00%) 
Depression  1  1/196 (0.51%)  8/199 (4.02%)  10/197 (5.08%)  3/30 (10.00%) 
Insomnia  1  47/196 (23.98%)  56/199 (28.14%)  50/197 (25.38%)  2/30 (6.67%) 
Irritability  1  17/196 (8.67%)  25/199 (12.56%)  21/197 (10.66%)  3/30 (10.00%) 
Mood swings  1  3/196 (1.53%)  7/199 (3.52%)  5/197 (2.54%)  3/30 (10.00%) 
Sleep disorder  1  15/196 (7.65%)  7/199 (3.52%)  11/197 (5.58%)  2/30 (6.67%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  10/196 (5.10%)  19/199 (9.55%)  28/197 (14.21%)  2/30 (6.67%) 
Dyspnoea  1  3/196 (1.53%)  3/199 (1.51%)  5/197 (2.54%)  2/30 (6.67%) 
Dyspnoea exertional  1  22/196 (11.22%)  22/199 (11.06%)  30/197 (15.23%)  1/30 (3.33%) 
Epistaxis  1  7/196 (3.57%)  2/199 (1.01%)  12/197 (6.09%)  0/30 (0.00%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  6/196 (3.06%)  9/199 (4.52%)  16/197 (8.12%)  0/30 (0.00%) 
Dry skin  1  15/196 (7.65%)  22/199 (11.06%)  25/197 (12.69%)  3/30 (10.00%) 
Pruritus  1  21/196 (10.71%)  24/199 (12.06%)  22/197 (11.17%)  6/30 (20.00%) 
Pruritus generalised  1  9/196 (4.59%)  16/199 (8.04%)  15/197 (7.61%)  0/30 (0.00%) 
Rash  1  24/196 (12.24%)  27/199 (13.57%)  39/197 (19.80%)  6/30 (20.00%) 
1
Term from vocabulary, MedDRA 18.0 and 19.0
Indicates events were collected by systematic assessment
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: NCT01962441     History of Changes
Other Study ID Numbers: GS-US-334-0153
2013-002641-11 ( EudraCT Number )
First Submitted: October 10, 2013
First Posted: October 14, 2013
Results First Submitted: January 7, 2016
Results First Posted: February 5, 2016
Last Update Posted: June 20, 2017