Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
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ClinicalTrials.gov Identifier: NCT01701401 |
Recruitment Status :
Completed
First Posted : October 5, 2012
Results First Posted : March 27, 2015
Last Update Posted : November 16, 2018
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | LDV/SOF 12 Weeks | LDV/SOF+RBV 12 Weeks | LDV/SOF 24 Weeks | LDV/SOF+RBV 24 Weeks | Total | |
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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 | |
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Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 214 participants | 217 participants | 217 participants | 217 participants | 865 participants | |
Female |
87 40.7%
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89 41.0%
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78 35.9%
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98 45.2%
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352 40.7%
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Male |
127 59.3%
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128 59.0%
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139 64.1%
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119 54.8%
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513 59.3%
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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 |
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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.
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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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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. |
EMail: | ClinicalTrialDisclosures@gilead.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01701401 |
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 |