Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
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ClinicalTrials.gov Identifier: NCT01726517 |
Recruitment Status :
Completed
First Posted : November 15, 2012
Results First Posted : November 17, 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 | 100 |
Participant Flow
Recruitment Details | Participants were enrolled at 1 study site in the United States. The first participant was screened on 22 October 2012. The last participant observation was on 13 January 2014. |
Pre-assignment Details | 116 participants were screened. |
Arm/Group Title | LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) |
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Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. |
Period Title: Overall Study | |||||
Started | 20 | 21 | 19 | 19 | 21 |
Completed | 20 | 21 | 18 | 19 | 21 |
Not Completed | 0 | 0 | 1 | 0 | 0 |
Reason Not Completed | |||||
Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) | Total | |
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Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 20 | 21 | 19 | 19 | 21 | 100 | |
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Safety Analysis Set: participants 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 | 20 participants | 21 participants | 19 participants | 19 participants | 21 participants | 100 participants | |
48 (10.7) | 50 (11.1) | 46 (11.6) | 54 (6.6) | 52 (9.8) | 50 (10.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 21 participants | 19 participants | 19 participants | 21 participants | 100 participants | |
Female |
6 30.0%
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9 42.9%
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8 42.1%
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4 21.1%
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7 33.3%
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34 34.0%
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Male |
14 70.0%
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12 57.1%
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11 57.9%
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15 78.9%
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14 66.7%
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66 66.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 21 participants | 19 participants | 19 participants | 21 participants | 100 participants | |
Hispanic or Latino |
3 15.0%
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12 57.1%
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9 47.4%
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6 31.6%
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10 47.6%
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40 40.0%
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Not Hispanic or Latino |
17 85.0%
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9 42.9%
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10 52.6%
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13 68.4%
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11 52.4%
|
60 60.0%
|
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Unknown or Not Reported |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 21 participants | 19 participants | 19 participants | 21 participants | 100 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
|
1 5.3%
|
0 0.0%
|
1 1.0%
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Asian |
1 5.0%
|
0 0.0%
|
1 5.3%
|
0 0.0%
|
0 0.0%
|
2 2.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
4 20.0%
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0 0.0%
|
1 5.3%
|
2 10.5%
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2 9.5%
|
9 9.0%
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White |
15 75.0%
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21 100.0%
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17 89.5%
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16 84.2%
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19 90.5%
|
88 88.0%
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More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Hepatitis C Virus (HCV) Genotype
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 20 participants | 21 participants | 19 participants | 19 participants | 21 participants | 100 participants |
1a | 17 | 19 | 17 | 18 | 16 | 87 | |
1b | 3 | 2 | 2 | 1 | 5 | 13 | |
[1]
Measure Description: There are variations within HCV genotype 1 which are distinct enough to be referred to as genotypes 1a or 1b.
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IL28b Status
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 20 participants | 21 participants | 19 participants | 19 participants | 21 participants | 100 participants |
CC | 4 | 7 | 1 | 2 | 1 | 15 | |
CT | 12 | 11 | 14 | 13 | 11 | 61 | |
TT | 4 | 3 | 4 | 4 | 9 | 24 | |
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
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HCV RNA (log10 IU/mL)
Mean (Standard Deviation) Unit of measure: Log10 IU/mL |
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Number Analyzed | 20 participants | 21 participants | 19 participants | 19 participants | 21 participants | 100 participants | |
6.1 (0.82) | 6.0 (0.84) | 6.1 (0.79) | 6.3 (0.49) | 6.2 (0.42) | 6.1 (0.69) | ||
HCV RNA Category
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 20 participants | 21 participants | 19 participants | 19 participants | 21 participants | 100 participants |
< 800,000 IU/mL | 9 | 7 | 7 | 4 | 5 | 32 | |
≥ 800,000 IU/mL | 11 | 14 | 12 | 15 | 16 | 68 | |
Prior HCV Treatment and Response
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 20 participants | 21 participants | 19 participants | 19 participants | 21 participants | 100 participants |
Non-responder to PI boceprevir | 0 | 0 | 0 | 9 | 9 | 18 | |
Relapse/Breakthrough to PI boceprevir | 0 | 0 | 0 | 2 | 2 | 4 | |
Non-responder to PI telaprevir | 0 | 0 | 0 | 3 | 6 | 9 | |
Relapse/Breakthrough to PI telaprevir | 0 | 0 | 0 | 5 | 4 | 9 | |
[1]
Measure Description: Prior HCV treatment and response was only collected for treatment-experienced participants in the LDV/SOF 12 Weeks (TE) and LDV/SOF+RBV 12 Weeks (TE) groups.
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Cirrhosis
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 20 participants | 21 participants | 19 participants | 19 participants | 21 participants | 100 participants |
No | 20 | 21 | 19 | 8 | 10 | 78 | |
Yes | 0 | 0 | 0 | 11 | 11 | 22 |
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: | NCT01726517 |
Other Study ID Numbers: |
GS-US-337-0118 |
First Submitted: | November 10, 2012 |
First Posted: | November 15, 2012 |
Results First Submitted: | November 7, 2014 |
Results First Posted: | November 17, 2014 |
Last Update Posted: | November 16, 2018 |