Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01260350
First received: December 13, 2010
Last updated: November 7, 2014
Last verified: November 2014
Results First Received: November 7, 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 Infection
Interventions: Drug: SOF
Drug: RBV
Drug: PEG
Drug: LDV
Drug: GS-9669
Drug: LDV/SOF

  Participant Flow
  Hide Participant Flow

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 in a total of 2 study sites in New Zealand. The first participant was screened on 18 November 2010. The last participant observation was on 23 December 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN Sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 5: SOF 12 wk: GT 2 or 3, TN SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 7: SOF+RBV 12 wk: GT 1, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
Group 8: SOF+RBV 12 wk: GT 1, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus ledipasvir (LDV) 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis LDV 90 mg/SOF 400 mg fixed-dose combination (FDC) once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Group 22: LDV/SOF FDC 6 wk: GT 1, TN Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.

Participant Flow:   Overall Study
    Group 1: SOF+RBV 12 wk: GT 2 or 3, TN     Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN     Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN     Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN     Group 5: SOF 12 wk: GT 2 or 3, TN     Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN     Group 7: SOF+RBV 12 wk: GT 1, TE     Group 8: SOF+RBV 12 wk: GT 1, TN     Group 9: SOF+RBV 12 wk: GT 2 or 3, TE     Group 10: SOF+RBV 8 wk: GT 2 or 3, TN     Group 11: SOF+RBV 12 wk: GT 2 or 3, TN     Group 12: SOF+RBV+LDV 12 wk: GT 1, TE     Group 13: SOF+RBV+LDV 12 wk: GT 1, TN     Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE     Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN     Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis     Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis     Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN     Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE     Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac     Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN     Group 22: LDV/SOF FDC 6 wk: GT 1, TN  
STARTED     10     9     10     11     10     10     10     25     25     25     10     9     25     10     25     10     9     10     0     14     25     0  
COMPLETED     10     9     10     11     10     10     10     25     24     25     10     9     25     10     25     10     9     9     0     14     22     0  
NOT COMPLETED     0     0     0     0     0     0     0     0     1     0     0     0     0     0     0     0     0     1     0     0     3     0  
Lack of Efficacy                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0                 0                 3                 0  
Did Not Complete Follow-up 12 Visit                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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 medication.

Reporting Groups
  Description
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 5: SOF 12 wk: GT 2 or 3, TN SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 7: SOF+RBV 12 wk: GT 1, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
Group 8: SOF+RBV 12 wk: GT 1, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Total Total of all reporting groups

Baseline Measures
    Group 1: SOF+RBV 12 wk: GT 2 or 3, TN     Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN     Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN     Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN     Group 5: SOF 12 wk: GT 2 or 3, TN     Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN     Group 7: SOF+RBV 12 wk: GT 1, TE     Group 8: SOF+RBV 12 wk: GT 1, TN     Group 9: SOF+RBV 12 wk: GT 2 or 3, TE     Group 10: SOF+RBV 8 wk: GT 2 or 3, TN     Group 11: SOF+RBV 12 wk: GT 2 or 3, TN     Group 12: SOF+RBV+LDV 12 wk: GT 1, TE     Group 13: SOF+RBV+LDV 12 wk: GT 1, TN     Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE     Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN     Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis     Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis     Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN     Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac     Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN     Total  
Number of Participants  
[units: participants]
  10     9     10     11     10     10     10     25     25     25     10     9     25     10     25     10     9     10     14     25     292  
Age  
[units: years]
Mean (Standard Deviation)
  47  (6.0)     47  (10.2)     49  (9.9)     46  (6.3)     43  (13.5)     39  (12.2)     48  (10.4)     48  (11.4)     53  (7.9)     48  (9.4)     39  (8.9)     50  (13.0)     45  (9.2)     55  (6.0)     46  (9.3)     61  (4.9)     57  (5.2)     39  (10.8)     54  (13.0)     51  (9.0)     48  (10.6)  
Gender  
[units: participants]
                                         
Female     2     4     5     2     6     5     3     10     6     8     3     2     17     3     12     0     1     7     2     12     110  
Male     8     5     5     9     4     5     7     15     19     17     7     7     8     7     13     10     8     3     12     13     182  
Ethnicity (NIH/OMB)  
[units: participants]
                                         
Hispanic or Latino     0     0     0     0     0     1     0     0     0     0     0     0     0     0     0     2     0     0     0     0     3  
Not Hispanic or Latino     10     9     10     11     10     9     10     25     25     25     10     9     25     10     25     8     9     10     14     25     289  
Unknown or Not Reported     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
                                         
White     7     4     8     9     10     7     9     20     17     20     9     9     23     9     20     8     9     7     12     22     239  
Asian     0     0     2     0     0     0     0     2     0     1     1     0     0     0     1     0     0     3     1     0     11  
Native Hawaiian of Other Pacific Islander     0     0     0     0     0     0     0     0     2     1     0     0     1     0     0     0     0     0     0     1     5  
American Indian or Alaska Native     0     1     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     1  
Other     3     4     0     2     0     3     1     3     6     3     0     0     1     1     4     2     0     0     1     2     36  
Hepatitis C Virus (HCV) RNA  
[units: log10┬áIU/mL]
Mean (Standard Deviation)
  6.7  (0.42)     6.6  (0.52)     6.4  (0.57)     6.3  (0.76)     5.7  (0.89)     6.1  (0.88)     6.8  (0.55)     6.1  (0.75)     6.5  (0.66)     6.1  (0.80)     6.2  (0.96)     6.9  (0.20)     5.9  (0.85)     7.0  (0.38)     6.3  (0.54)     6.5  (0.57)     6.3  (0.78)     6.1  (0.94)     6.5  (0.51)     6.5  (0.56)     6.3  (0.73)  
HCV RNA Category  
[units: participants]
                                         
< 6 log10 IU/mL     1     1     3     3     5     5     1     10     5     12     4     0     11     0     8     2     3     5     2     6     87  
≥ 6 log10 IU/mL     9     8     7     8     5     5     9     15     20     13     6     9     14     10     17     8     6     5     12     19     205  
HCV Genotype [1]
[units: participants]
                                         
Genotype 1     0     0     0     0     0     0     10     25     0     0     0     9     25     10     25     10     9     0     14     25     162  
Genotype 2     4     3     4     4     3     0     0     0     6     5     0     0     0     0     0     0     0     2     0     0     31  
Genotype 3     6     6     6     7     7     10     0     0     19     20     10     0     0     0     0     0     0     8     0     0     99  
IL28b Genotype [2]
[units: participants]
                                         
CC     5     4     4     4     2     3     10     25     0     13     4     0     9     1     7     4     2     3     4     5     109  
CT     4     4     4     5     6     6     0     0     6     12     5     7     14     8     14     4     5     6     7     15     132  
TT     1     1     2     2     2     1     0     0     19     0     1     2     2     1     4     2     2     1     3     5     51  
Cirrhosis Status  
[units: participants]
                                         
Yes     0     0     0     0     0     0     0     0     0     0     0     0     0     0     0     10     9     0     1     0     20  
No     10     9     10     11     10     10     10     25     25     25     10     9     25     10     25     0     0     10     13     25     272  
[1] 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.
[2] CC, CT, and TT alleles are different forms of the IL28b gene.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Experienced Adverse Events   [ Time Frame: Up to 12 weeks plus 30 days ]

2.  Secondary:   Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)   [ Time Frame: Posttreatment Week 12 ]

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

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

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

6.  Secondary:   Change From Baseline in HCV RNA at Week 6   [ Time Frame: Baseline to Week 6 ]

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

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

9.  Secondary:   Percentage of Participants With Virologic Failure   [ Time Frame: Up 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
No text entered.


  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


Publications of Results:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01260350     History of Changes
Other Study ID Numbers: P7977-0523, Medsafe
Study First Received: December 13, 2010
Results First Received: November 7, 2014
Last Updated: November 7, 2014
Health Authority: New Zealand: Medsafe