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Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection (ION-2)

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: NCT01768286
Recruitment Status : Completed
First Posted : January 15, 2013
Results First Posted : November 26, 2014
Last Update Posted : November 16, 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 Hepatitis C Virus
Interventions Drug: LDV/SOF
Drug: RBV
Enrollment 441
Recruitment Details Participants were enrolled at a total of 64 study sites in the United States. The first participant was screened on 03 January 2013. The last participant observation occurred on 20 February 2014.
Pre-assignment Details 551 participants were screened.
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Period Title: Overall Study
Started 109 111 110 111
Completed 102 107 108 110
Not Completed 7 4 2 1
Reason Not Completed
Randomized But Not Treated             0             0             1             0
Lack of Efficacy             7             4             0             1
Withdrew Consent             0             0             1             0
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks Total
Hide Arm/Group Description LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 109 111 109 111 440
Hide Baseline Analysis Population Description
Safety Analysis Set: participants were randomized and received at least one dose of study drug. Participants failed a previous HCV treatment regimen consisting of pegylated interferon alfa-2a (Pegasys) or pegylated interferon alfa-2b (Pegintron) plus ribavirin (RBV), with or without a protease inhibitor (PI).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 111 participants 109 participants 111 participants 440 participants
56  (6.9) 57  (8.0) 56  (8.3) 55  (7.8) 56  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 111 participants 109 participants 111 participants 440 participants
Female
35
  32.1%
40
  36.0%
35
  32.1%
43
  38.7%
153
  34.8%
Male
74
  67.9%
71
  64.0%
74
  67.9%
68
  61.3%
287
  65.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 109 participants 111 participants 109 participants 111 participants 440 participants
Black or African American 24 16 17 20 77
White 84 94 91 89 358
Asian 1 0 0 0 1
Hawaiian or Pacific Islander 0 1 0 1 2
Other 0 0 1 1 2
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 109 participants 111 participants 109 participants 111 participants 440 participants
Hispanic/Latino 7 12 11 11 41
Not Hispanic or Latino 100 99 98 99 396
Not Disclosed 2 0 0 1 3
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 109 participants 111 participants 109 participants 111 participants 440 participants
6.5  (0.44) 6.4  (0.54) 6.4  (0.57) 6.5  (0.60) 6.5  (0.54)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 109 participants 111 participants 109 participants 111 participants 440 participants
< 800,000 IU/mL 6 13 16 15 50
≥ 800,000 IU/mL 103 98 93 96 390
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 109 participants 111 participants 109 participants 111 participants 440 participants
Genotype 1a 86 88 85 88 347
Genotype 1b 23 23 24 23 93
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 109 participants 111 participants 109 participants 111 participants 440 participants
CC 10 11 16 18 55
CT 70 77 68 68 283
TT 29 23 25 25 102
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
Prior HCV Treatment   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 109 participants 111 participants 109 participants 111 participants 440 participants
PEG-IFN-alfa-2a or PEG-IFN-alfa-2b+RBV 43 47 58 59 207
PI+PEG-IFN-alfa-2a or PEG-IFN-alfa-2b+RBV 66 64 50 51 231
IFN-alfa-2b+RBV 0 0 1 1 2
[1]
Measure Description: IFN-alfa-2b = interferon-alfa 2b; PEG-IFN-alfa-2a = pegylated interferon alfa-2a; PEG-IFN-alfa-2b - pegylated interferon alfa-2b; RBV = ribavirin; PI = protease inhibitor
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) 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 were randomized and received at least one dose of study drug.
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 111
Measure Type: Number
Unit of Measure: percentage of participants
93.6 96.4 99.1 99.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LDV/SOF 12 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.
Method Binomial test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LDV/SOF+RBV 12 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.
Method Binomial test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LDV/SOF 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.
Method Binomial test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LDV/SOF+RBV 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.
Method Binomial test
Comments [Not Specified]
2.Primary Outcome
Title Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
Hide Description The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 111
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0
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 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 111
Measure Type: Number
Unit of Measure: percentage of participants
SVR4 94.5 96.4 100.0 99.1
SVR24 93.6 96.4 99.1 99.1
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 1
Hide Description [Not Specified]
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 111
Measure Type: Number
Unit of Measure: percentage of participants
26.6 33.3 20.2 29.7
5.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 2
Hide Description [Not Specified]
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 111
Measure Type: Number
Unit of Measure: percentage of participants
81.7 82.9 81.7 83.8
6.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 4
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 111
Measure Type: Number
Unit of Measure: percentage of participants
100.0 99.1 99.1 99.1
7.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 8
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 110
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 100.0 100.0
8.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 12
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 110
Measure Type: Number
Unit of Measure: percentage of participants
99.1 100.0 100.0 100.0
9.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 24
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed. Participants in the LDV/SOF 12 Weeks and LDV/SOF+RBV 12 Weeks groups did not continue treatment past Week 12 and are not included in the analysis.
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 0 0 107 110
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0
10.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 1
Hide Description [Not Specified]
Time Frame Baseline; Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 108 111 109 110
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.57  (0.501) -4.50  (0.540) -4.47  (0.569) -4.50  (0.575)
11.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 2
Hide Description [Not Specified]
Time Frame Baseline; Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 111
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.08  (0.443) -4.94  (0.520) -4.99  (0.571) -4.99  (0.617)
12.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 4
Hide Description [Not Specified]
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 111
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.16  (0.439) -5.02  (0.543) -5.06  (0.571) -5.04  (0.779)
13.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 8
Hide Description [Not Specified]
Time Frame Baseline; Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 110
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.16  (0.439) -5.02  (0.544) -5.06  (0.571) -5.08  (0.605)
14.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

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

  • On-Treatment Virologic Failure 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)

Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Time Frame Baseline to posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
Overall Number of Participants Analyzed 109 111 109 111
Measure Type: Number
Unit of Measure: percentage of participants
On-Treatment Virologic Failure 0 0 0 0.9
Virologic relapse 6.5 3.6 0 0
Time Frame Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Hide Arm/Group Description LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
All-Cause Mortality
LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/109 (0.00%)   0/111 (0.00%)   6/109 (5.50%)   3/111 (2.70%) 
Cardiac disorders         
Angina unstable † 1  0/109 (0.00%)  0/111 (0.00%)  1/109 (0.92%)  0/111 (0.00%) 
Gastrointestinal disorders         
Upper gastrointestinal haemorrhage † 1  0/109 (0.00%)  0/111 (0.00%)  1/109 (0.92%)  0/111 (0.00%) 
General disorders         
Non-cardiac chest pain † 1  0/109 (0.00%)  0/111 (0.00%)  1/109 (0.92%)  0/111 (0.00%) 
Hepatobiliary disorders         
Cholecystitis acute † 1  0/109 (0.00%)  0/111 (0.00%)  0/109 (0.00%)  1/111 (0.90%) 
Infections and infestations         
Wound infection † 1  0/109 (0.00%)  0/111 (0.00%)  0/109 (0.00%)  1/111 (0.90%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion † 1  0/109 (0.00%)  0/111 (0.00%)  1/109 (0.92%)  0/111 (0.00%) 
Spondylolisthesis † 1  0/109 (0.00%)  0/111 (0.00%)  1/109 (0.92%)  0/111 (0.00%) 
Nervous system disorders         
Convulsion † 1  0/109 (0.00%)  0/111 (0.00%)  1/109 (0.92%)  0/111 (0.00%) 
Hepatic encephalopathy † 1  0/109 (0.00%)  0/111 (0.00%)  1/109 (0.92%)  0/111 (0.00%) 
Reproductive system and breast disorders         
Vaginal prolapse † 1  0/109 (0.00%)  0/111 (0.00%)  0/109 (0.00%)  1/111 (0.90%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF 12 Weeks LDV/SOF+RBV 12 Weeks LDV/SOF 24 Weeks LDV/SOF+RBV 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   73/109 (66.97%)   96/111 (86.49%)   87/109 (79.82%)   100/111 (90.09%) 
Blood and lymphatic system disorders         
Anaemia † 1  0/109 (0.00%)  9/111 (8.11%)  1/109 (0.92%)  12/111 (10.81%) 
Gastrointestinal disorders         
Nausea † 1  13/109 (11.93%)  20/111 (18.02%)  7/109 (6.42%)  25/111 (22.52%) 
Diarrhoea † 1  7/109 (6.42%)  5/111 (4.50%)  9/109 (8.26%)  17/111 (15.32%) 
Constipation † 1  2/109 (1.83%)  4/111 (3.60%)  6/109 (5.50%)  3/111 (2.70%) 
Vomiting † 1  2/109 (1.83%)  3/111 (2.70%)  0/109 (0.00%)  9/111 (8.11%) 
Abdominal pain † 1  6/109 (5.50%)  2/111 (1.80%)  0/109 (0.00%)  5/111 (4.50%) 
General disorders         
Fatigue † 1  23/109 (21.10%)  45/111 (40.54%)  26/109 (23.85%)  50/111 (45.05%) 
Irritability † 1  2/109 (1.83%)  13/111 (11.71%)  4/109 (3.67%)  12/111 (10.81%) 
Infections and infestations         
Upper respiratory tract infection † 1  4/109 (3.67%)  6/111 (5.41%)  7/109 (6.42%)  11/111 (9.91%) 
Bronchitis † 1  2/109 (1.83%)  3/111 (2.70%)  4/109 (3.67%)  8/111 (7.21%) 
Nasopharyngitis † 1  3/109 (2.75%)  5/111 (4.50%)  3/109 (2.75%)  6/111 (5.41%) 
Sinusitis † 1  1/109 (0.92%)  6/111 (5.41%)  3/109 (2.75%)  7/111 (6.31%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  7/109 (6.42%)  13/111 (11.71%)  7/109 (6.42%)  17/111 (15.32%) 
Myalgia † 1  5/109 (4.59%)  6/111 (5.41%)  8/109 (7.34%)  10/111 (9.01%) 
Muscle spasms † 1  1/109 (0.92%)  8/111 (7.21%)  2/109 (1.83%)  12/111 (10.81%) 
Back pain † 1  3/109 (2.75%)  3/111 (2.70%)  4/109 (3.67%)  10/111 (9.01%) 
Nervous system disorders         
Headache † 1  28/109 (25.69%)  26/111 (23.42%)  25/109 (22.94%)  35/111 (31.53%) 
Dizziness † 1  3/109 (2.75%)  8/111 (7.21%)  7/109 (6.42%)  12/111 (10.81%) 
Psychiatric disorders         
Insomnia † 1  10/109 (9.17%)  18/111 (16.22%)  4/109 (3.67%)  19/111 (17.12%) 
Anxiety † 1  2/109 (1.83%)  7/111 (6.31%)  4/109 (3.67%)  3/111 (2.70%) 
Respiratory, thoracic and mediastinal disorders         
Cough † 1  5/109 (4.59%)  16/111 (14.41%)  5/109 (4.59%)  16/111 (14.41%) 
Dyspnoea † 1  0/109 (0.00%)  16/111 (14.41%)  3/109 (2.75%)  9/111 (8.11%) 
Nasal congestion † 1  6/109 (5.50%)  3/111 (2.70%)  1/109 (0.92%)  3/111 (2.70%) 
Dyspnoea exertional † 1  0/109 (0.00%)  5/111 (4.50%)  0/109 (0.00%)  6/111 (5.41%) 
Oropharyngeal pain † 1  1/109 (0.92%)  3/111 (2.70%)  0/109 (0.00%)  6/111 (5.41%) 
Skin and subcutaneous tissue disorders         
Rash † 1  2/109 (1.83%)  11/111 (9.91%)  6/109 (5.50%)  16/111 (14.41%) 
Pruritus † 1  5/109 (4.59%)  10/111 (9.01%)  2/109 (1.83%)  10/111 (9.01%) 
Dry skin † 1  0/109 (0.00%)  3/111 (2.70%)  3/109 (2.75%)  11/111 (9.91%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
[Not Specified]
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
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Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
EMail: ClinicalTrialDisclosures@gilead.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01768286    
Other Study ID Numbers: GS-US-337-0109
First Submitted: January 10, 2013
First Posted: January 15, 2013
Results First Submitted: November 21, 2014
Results First Posted: November 26, 2014
Last Update Posted: November 16, 2018