Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection (ION-2)
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ClinicalTrials.gov Identifier: NCT01768286 |
Recruitment Status :
Completed
First Posted : January 15, 2013
Results First Posted : November 26, 2014
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 | 441 |
Participant Flow
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 |
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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 |
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 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 | |
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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).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 109 participants | 111 participants | 109 participants | 111 participants | 440 participants | |
Female |
35 32.1%
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40 36.0%
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35 32.1%
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43 38.7%
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153 34.8%
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Male |
74 67.9%
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71 64.0%
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74 67.9%
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68 61.3%
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287 65.2%
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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 |
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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.
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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
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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: | 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 |