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Trial record 26 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

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: NCT01701401
Recruitment Status : Completed
First Posted : October 5, 2012
Results First Posted : March 27, 2015
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 870
Recruitment Details Participants were enrolled at a total of 100 study sites in the United States and Europe. The first participant was screened on 26 September 2012. The last study visit occurred on 30 April 2014.
Pre-assignment Details 1015 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/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet once daily for 12 weeks LDV/SOF 90/400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
Period Title: Overall Study
Started 217 218 217 218
Completed 207 209 212 212
Not Completed 10 9 5 6
Reason Not Completed
Randomized But Not Treated             3             1             0             1
Lost to Follow-up             5             5             1             3
Withdrew Consent             0             3             1             2
Lack of Efficacy             1             0             2             0
Adverse Event             1             0             0             0
Protocol Violation             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/SOF 90/400 mg FDC tablet once daily for 12 weeks LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 214 217 217 217 865
Hide Baseline Analysis Population Description
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 214 participants 217 participants 217 participants 217 participants 865 participants
52  (10.7) 52  (11.5) 53  (10.3) 53  (9.9) 52  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 217 participants 217 participants 217 participants 865 participants
Female
87
  40.7%
89
  41.0%
78
  35.9%
98
  45.2%
352
  40.7%
Male
127
  59.3%
128
  59.0%
139
  64.1%
119
  54.8%
513
  59.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants 217 participants 217 participants 217 participants 865 participants
Black or African American 24 26 32 26 108
White 187 188 177 183 735
Asian 1 0 5 5 11
American Indian/Alaska Native 0 1 0 1 2
Hawaiian or Pacific Islander 0 0 1 0 1
Other 2 1 2 1 6
Not Disclosed 0 1 0 1 2
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants 217 participants 217 participants 217 participants 865 participants
Hispanic or Latino 26 20 29 26 101
Not Hispanic or Latino 187 197 188 190 762
Not Disclosed 1 0 0 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants 217 participants 217 participants 217 participants 865 participants
France 11 24 18 10 63
United States 125 118 132 137 512
Spain 14 15 12 14 55
Germany 24 20 22 18 84
United Kingdom 13 17 10 15 55
Italy 27 23 23 23 96
Hepatitis C Virus (HCV) RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 214 participants 217 participants 217 participants 217 participants 865 participants
6.4  (0.69) 6.4  (0.64) 6.3  (0.68) 6.3  (0.65) 6.4  (0.66)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants 217 participants 217 participants 217 participants 865 participants
< 800,000 IU/mL 45 44 49 44 182
≥ 800,000 IU/mL 169 173 168 173 683
HCV Genotype   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants 217 participants 217 participants 217 participants 865 participants
Genotype 1a 144 148 146 143 581
Genotype 1b 66 68 68 71 273
Genotype 1 (no confirmed subtype) 1 1 1 1 4
Genotype 4 1 0 0 1 2
Missing 2 0 2 1 5
[1]
Measure Description: There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes.
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants 217 participants 217 participants 217 participants 865 participants
CC 55 76 52 73 256
CT 113 107 119 112 451
TT 46 34 46 32 158
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)
Hide Description SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants were randomized and received at least 1 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/SOF 90/400 mg FDC tablet once daily for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
Overall Number of Participants Analyzed 214 217 217 217
Measure Type: Number
Unit of Measure: percentage of participants
98.6 97.2 98.2 99.1
Show Statistical Analysis 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 The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.
Method Binomial test
Comments [Not Specified]
Show Statistical Analysis 2 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 The p-value for the comparison of the LDV/SOF+RBV 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.
Method Binomial test
Comments [Not Specified]
Show Statistical Analysis 3 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 The p-value for the comparison of the LDV/SOF 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.
Method Binomial test
Comments [Not Specified]
Show Statistical Analysis 4 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 The p-value for the comparison of the LDV/SOF+RBV 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.
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: participants were randomized and received at least 1 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/SOF 90/400 mg FDC tablet once daily for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
Overall Number of Participants Analyzed 214 217 217 217
Measure Type: Number
Unit of Measure: percentage of participants
0 0.5 1.8 3.7
3.Secondary Outcome
Title Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug
Hide Description SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation 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/SOF 90/400 mg FDC tablet once daily for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
Overall Number of Participants Analyzed 214 217 217 217
Measure Type: Number
Unit of Measure: percentage of participants
SVR4 98.6 98.2 99.1 99.1
SVR24 98.6 97.2 98.2 99.1
4.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
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/SOF 90/400 mg FDC tablet once daily for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
Overall Number of Participants Analyzed 213 217 216 217
Measure Type: Number
Unit of Measure: percentage of participants
82.2 83.4 82.9 82.9
5.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
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/SOF 90/400 mg FDC tablet once daily for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
Overall Number of Participants Analyzed 213 217 216 217
Measure Type: Number
Unit of Measure: percentage of participants
100 99.1 100 100
6.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/SOF 90/400 mg FDC tablet once daily for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
Overall Number of Participants Analyzed 213 215 215 217
Measure Type: Number
Unit of Measure: percentage of participants
99.5 100 99.5 100
7.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
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/SOF 90/400 mg FDC tablet once daily for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
Overall Number of Participants Analyzed 213 217 216 216
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.90  (0.657) -4.94  (0.633) -4.86  (0.670) -4.89  (0.648)
8.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
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/SOF 90/400 mg FDC tablet once daily for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
Overall Number of Participants Analyzed 213 216 216 217
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.99  (0.697) -5.02  (0.623) -4.93  (0.678) -4.96  (0.651)
9.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/SOF 90/400 mg FDC tablet once daily for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
Overall Number of Participants Analyzed 213 215 216 217
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.99  (0.696) -5.02  (0.625) -4.91  (0.702) -4.96  (0.651)
10.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

On-treatment virologic failure was defined as:

  • Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR
  • Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR
  • Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment

Virologic relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement

Time Frame 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/SOF 90/400 mg FDC tablet once daily for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
Overall Number of Participants Analyzed 214 217 217 217
Measure Type: Number
Unit of Measure: percentage of participants
On-treatment virologic failure 0 0 0.5 0
Virologic relapse 0.5 0 0.5 0
Time Frame Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants were randomized and received at least 1 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/SOF 90/400 mg FDC tablet once daily for 12 weeks LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose 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   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events 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   1/214 (0.47%)   7/217 (3.23%)   18/217 (8.29%)   7/217 (3.23%) 
Blood and lymphatic system disorders         
Anaemia  1  0/214 (0.00%)  1/217 (0.46%)  0/217 (0.00%)  0/217 (0.00%) 
Factor VIII inhibition  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Lymphadenopathy  1  0/214 (0.00%)  0/217 (0.00%)  0/217 (0.00%)  1/217 (0.46%) 
Gastrointestinal disorders         
Abdominal discomfort  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Colitis  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Mesenteric vein thrombosis  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
General disorders         
Chest pain  1  1/214 (0.47%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Non-cardiac chest pain  1  0/214 (0.00%)  1/217 (0.46%)  1/217 (0.46%)  0/217 (0.00%) 
Infections and infestations         
Cellulitis  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  1/217 (0.46%) 
Gastroenteritis  1  0/214 (0.00%)  0/217 (0.00%)  2/217 (0.92%)  0/217 (0.00%) 
Pneumonia  1  0/214 (0.00%)  1/217 (0.46%)  0/217 (0.00%)  1/217 (0.46%) 
Progressive multifocal leukoencephalopathy  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Salpingitis  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Urinary tract infection  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Injury, poisoning and procedural complications         
Hand fracture  1  0/214 (0.00%)  0/217 (0.00%)  2/217 (0.92%)  0/217 (0.00%) 
Alcohol poisoning  1  0/214 (0.00%)  0/217 (0.00%)  0/217 (0.00%)  1/217 (0.46%) 
Concussion  1  0/214 (0.00%)  0/217 (0.00%)  0/217 (0.00%)  1/217 (0.46%) 
Fall  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Foot fracture  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Lower limb fracture  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Rib fracture  1  0/214 (0.00%)  0/217 (0.00%)  0/217 (0.00%)  1/217 (0.46%) 
Tibia fracture  1  0/214 (0.00%)  1/217 (0.46%)  0/217 (0.00%)  0/217 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  0/214 (0.00%)  1/217 (0.46%)  0/217 (0.00%)  0/217 (0.00%) 
Lumbar spinal stenosis  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Squamous cell carcinoma  1  0/214 (0.00%)  0/217 (0.00%)  0/217 (0.00%)  1/217 (0.46%) 
Nervous system disorders         
Carotid artery stenosis  1  0/214 (0.00%)  0/217 (0.00%)  0/217 (0.00%)  1/217 (0.46%) 
Headache  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Migraine  1  0/214 (0.00%)  1/217 (0.46%)  0/217 (0.00%)  0/217 (0.00%) 
Psychiatric disorders         
Alcohol withdrawal syndrome  1  0/214 (0.00%)  0/217 (0.00%)  0/217 (0.00%)  1/217 (0.46%) 
Depression  1  0/214 (0.00%)  0/217 (0.00%)  0/217 (0.00%)  1/217 (0.46%) 
Substance abuse  1  0/214 (0.00%)  0/217 (0.00%)  0/217 (0.00%)  1/217 (0.46%) 
Renal and urinary disorders         
Calculus ureteric  1  0/214 (0.00%)  0/217 (0.00%)  0/217 (0.00%)  1/217 (0.46%) 
Reproductive system and breast disorders         
Breast mass  1  0/214 (0.00%)  0/217 (0.00%)  1/217 (0.46%)  0/217 (0.00%) 
Vascular disorders         
Hypertension  1  0/214 (0.00%)  1/217 (0.46%)  0/217 (0.00%)  0/217 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events 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   140/214 (65.42%)   168/217 (77.42%)   149/217 (68.66%)   189/217 (87.10%) 
Blood and lymphatic system disorders         
Anaemia  1  0/214 (0.00%)  25/217 (11.52%)  0/217 (0.00%)  22/217 (10.14%) 
Gastrointestinal disorders         
Nausea  1  24/214 (11.21%)  37/217 (17.05%)  29/217 (13.36%)  32/217 (14.75%) 
Diarrhoea  1  24/214 (11.21%)  18/217 (8.29%)  24/217 (11.06%)  14/217 (6.45%) 
Constipation  1  13/214 (6.07%)  12/217 (5.53%)  15/217 (6.91%)  10/217 (4.61%) 
Dyspepsia  1  7/214 (3.27%)  11/217 (5.07%)  14/217 (6.45%)  12/217 (5.53%) 
Abdominal pain  1  12/214 (5.61%)  9/217 (4.15%)  7/217 (3.23%)  8/217 (3.69%) 
Vomiting  1  7/214 (3.27%)  9/217 (4.15%)  6/217 (2.76%)  12/217 (5.53%) 
Abdominal pain upper  1  5/214 (2.34%)  11/217 (5.07%)  7/217 (3.23%)  9/217 (4.15%) 
Gastrooesophageal reflux disease  1  4/214 (1.87%)  7/217 (3.23%)  3/217 (1.38%)  11/217 (5.07%) 
General disorders         
Fatigue  1  46/214 (21.50%)  79/217 (36.41%)  53/217 (24.42%)  84/217 (38.71%) 
Asthenia  1  14/214 (6.54%)  23/217 (10.60%)  20/217 (9.22%)  26/217 (11.98%) 
Irritability  1  11/214 (5.14%)  17/217 (7.83%)  17/217 (7.83%)  24/217 (11.06%) 
Infections and infestations         
Nasopharyngitis  1  14/214 (6.54%)  9/217 (4.15%)  13/217 (5.99%)  19/217 (8.76%) 
Metabolism and nutrition disorders         
Decreased appetite  1  10/214 (4.67%)  12/217 (5.53%)  8/217 (3.69%)  9/217 (4.15%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  9/214 (4.21%)  14/217 (6.45%)  21/217 (9.68%)  13/217 (5.99%) 
Myalgia  1  9/214 (4.21%)  13/217 (5.99%)  12/217 (5.53%)  12/217 (5.53%) 
Back pain  1  12/214 (5.61%)  5/217 (2.30%)  12/217 (5.53%)  14/217 (6.45%) 
Muscle spasms  1  7/214 (3.27%)  14/217 (6.45%)  9/217 (4.15%)  12/217 (5.53%) 
Nervous system disorders         
Headache  1  54/214 (25.23%)  50/217 (23.04%)  54/217 (24.88%)  66/217 (30.41%) 
Dizziness  1  11/214 (5.14%)  10/217 (4.61%)  14/217 (6.45%)  18/217 (8.29%) 
Psychiatric disorders         
Insomnia  1  17/214 (7.94%)  45/217 (20.74%)  26/217 (11.98%)  46/217 (21.20%) 
Anxiety  1  7/214 (3.27%)  9/217 (4.15%)  12/217 (5.53%)  19/217 (8.76%) 
Depression  1  5/214 (2.34%)  6/217 (2.76%)  5/217 (2.30%)  11/217 (5.07%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  6/214 (2.80%)  22/217 (10.14%)  16/217 (7.37%)  25/217 (11.52%) 
Dyspnoea  1  3/214 (1.40%)  18/217 (8.29%)  5/217 (2.30%)  15/217 (6.91%) 
Dyspnoea exertional  1  3/214 (1.40%)  9/217 (4.15%)  2/217 (0.92%)  11/217 (5.07%) 
Skin and subcutaneous tissue disorders         
Rash  1  16/214 (7.48%)  21/217 (9.68%)  16/217 (7.37%)  26/217 (11.98%) 
Pruritus  1  11/214 (5.14%)  22/217 (10.14%)  8/217 (3.69%)  20/217 (9.22%) 
Dry skin  1  2/214 (0.93%)  14/217 (6.45%)  3/217 (1.38%)  13/217 (5.99%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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, Inc.
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01701401     History of Changes
Other Study ID Numbers: GS-US-337-0102
2012-003387-43 ( EudraCT Number )
First Submitted: October 2, 2012
First Posted: October 5, 2012
Results First Submitted: March 17, 2015
Results First Posted: March 27, 2015
Last Update Posted: November 16, 2018