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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01768286
First received: January 10, 2013
Last updated: November 21, 2014
Last verified: November 2014
Results First Received: November 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Hepatitis C Virus
Interventions: Drug: LDV/SOF
Drug: RBV

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
551 participants were screened.

Reporting Groups
  Description
LDV/SOF 12 Weeks Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
LDV/SOF+RBV 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/SOF 24 Weeks LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV/SOF+RBV 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

Participant Flow:   Overall Study
    LDV/SOF 12 Weeks     LDV/SOF+RBV 12 Weeks     LDV/SOF 24 Weeks     LDV/SOF+RBV 24 Weeks  
STARTED     109     111     110     111  
COMPLETED     102     107     108     110  
NOT COMPLETED     7     4     2     1  
Randomized But Not Treated                 0                 0                 1                 0  
Lack of Efficacy                 7                 4                 0                 1  
Withdrew Consent                 0                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
LDV/SOF 12 Weeks LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
LDV/SOF+RBV 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/SOF 24 Weeks LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
LDV/SOF+RBV 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 Total of all reporting groups

Baseline Measures
    LDV/SOF 12 Weeks     LDV/SOF+RBV 12 Weeks     LDV/SOF 24 Weeks     LDV/SOF+RBV 24 Weeks     Total  
Number of Participants  
[units: participants]
  109     111     109     111     440  
Age  
[units: years]
Mean ± Standard Deviation
  56  ± 6.9     57  ± 8.0     56  ± 8.3     55  ± 7.8     56  ± 7.8  
Gender  
[units: participants]
         
Female     35     40     35     43     153  
Male     74     71     74     68     287  
Race/Ethnicity, Customized  
[units: 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  
[units: 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  
[units: log10┬áIU/mL]
Mean ± Standard Deviation
  6.5  ± 0.44     6.4  ± 0.54     6.4  ± 0.57     6.5  ± 0.60     6.5  ± 0.54  
HCV RNA Category  
[units: participants]
         
< 800,000 IU/mL     6     13     16     15     50  
≥ 800,000 IU/mL     103     98     93     96     390  
HCV Genotype  
[units: participants]
         
Genotype 1a     86     88     85     88     347  
Genotype 1b     23     23     24     23     93  
IL28b Status [1]
[units: participants]
         
CC     10     11     16     18     55  
CT     70     77     68     68     283  
TT     29     23     25     25     102  
Prior HCV Treatment [2]
[units: 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] CC, CT, and TT alleles are different forms of the IL28b gene.
[2] 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



  Outcome Measures
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1.  Primary:   Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)   [ Time Frame: Posttreatment Week 12 ]

2.  Primary:   Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug   [ Time Frame: Up to 24 weeks ]

3.  Secondary:   Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)   [ Time Frame: Posttreatment Weeks 4 and 24 ]

4.  Secondary:   Percentage of Participants With HCV RNA < LLOQ at Week 1   [ Time Frame: Week 1 ]

5.  Secondary:   Percentage of Participants With HCV RNA < LLOQ at Week 2   [ Time Frame: Week 2 ]

6.  Secondary:   Percentage of Participants With HCV RNA < LLOQ at Week 4   [ Time Frame: Week 4 ]

7.  Secondary:   Percentage of Participants With HCV RNA < LLOQ at Week 8   [ Time Frame: Week 8 ]

8.  Secondary:   Percentage of Participants With HCV RNA < LLOQ at Week 12   [ Time Frame: Week 12 ]

9.  Secondary:   Percentage of Participants With HCV RNA < LLOQ at Week 24   [ Time Frame: Week 24 ]

10.  Secondary:   Change From Baseline in HCV RNA at Week 1   [ Time Frame: Baseline; Week 1 ]

11.  Secondary:   Change From Baseline in HCV RNA at Week 2   [ Time Frame: Baseline; Week 2 ]

12.  Secondary:   Change From Baseline in HCV RNA at Week 4   [ Time Frame: Baseline; Week 4 ]

13.  Secondary:   Change From Baseline in HCV RNA at Week 8   [ Time Frame: Baseline; Week 8 ]

14.  Secondary:   Percentage of Participants With Virologic Failure   [ Time Frame: Baseline to posttreatment Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


No publications provided by Gilead Sciences

Publications automatically indexed to this study:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01768286     History of Changes
Other Study ID Numbers: GS-US-337-0109
Study First Received: January 10, 2013
Results First Received: November 21, 2014
Last Updated: November 21, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board