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Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02073656
First received: February 25, 2014
Last updated: August 30, 2016
Last verified: August 2016
Results First Received: August 30, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hepatitis C Virus
HIV
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 study sites in the United States (including Puerto Rico), Canada, and New Zealand. The first participant was screened on 24 February 2014. The last study visit occurred on 01 December 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
429 participants were screened.

Reporting Groups
  Description
LDV/SOF 12 Weeks

Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.

Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 24 weeks.


Participant Flow for 2 periods

Period 1:   Primary Study
    LDV/SOF 12 Weeks
STARTED   335 
COMPLETED   327 
NOT COMPLETED   8 
Lost to Follow-up                6 
Death                1 
Withdrew Consent                1 

Period 2:   Retreatment Substudy
    LDV/SOF 12 Weeks
STARTED   9 [1] 
COMPLETED   9 
NOT COMPLETED   0 
[1] Only participants experiencing virologic relapse in the Primary Study were eligible for retreatment.



  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 who enrolled and received at least 1 dose of study drug.

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

Baseline Measures
   LDV/SOF 12 Weeks 
Overall Participants Analyzed 
[Units: Participants]
 335 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (8.0) 
Gender 
[Units: Participants]
 
Female   59 
Male   276 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   56 
Not Hispanic or Latino   276 
Unknown or Not Reported   3 
Race/Ethnicity, Customized 
[Units: Participants]
 
Black or African American   115 
White   203 
Asian   6 
American Indian/ Alaska Native   2 
Other   6 
Not Disclosed   3 
Region of Enrollment 
[Units: Participants]
 
New Zealand   9 
Canada   26 
United States   290 
Puerto Rico   10 
HCV Genotype 
[Units: Participants]
 
Genotype 1a   250 
Genotype 1b   77 
Genotype 4   8 
Cirrhosis Status 
[Units: Participants]
 
No   268 
Yes   67 
IL28b Status [1] 
[Units: Participants]
 
CC   81 
CT   185 
TT   69 
[1] The CC, CT, and TT alleles are different forms of the IL28b gene.
Baseline HCV RNA 
[Units: Log10 IU/mL]
Mean (Standard Deviation)
 6.7  (0.64) 
Baseline HCV RNA Category 
[Units: Participants]
 
< 800,000 IU/mL   36 
≥ 800,000 IU/mL   299 
Baseline Serum Creatinine 
[Units: mg/dL]
Mean (Standard Deviation)
 1.00  (0.210) 
Estimated Glomerular Filtration Rate Using the Cockcroft-Gault Equation 
[Units: mL/min]
Mean (Standard Deviation)
 101.6  (30.78) 
Baseline CD4 Count 
[Units: cells/uL]
Mean (Standard Deviation)
 662  (293.8) 
Prior HCV Treatment [1] 
[Units: Participants]
 
Treatment-Naive   150 
Treatment-Experienced with DAA+Peg-IFN+RBV   53 
Treatment-Experienced with Peg-IFN+RBV   113 
Treatment-Experienced with DAA+RBV   14 
Treatment-Experienced with Other   5 
[1]

Acronyms for prior treatment:

DAA = direct-acting antiviral; Peg-IFN = pegylated interferon; RBV = ribavirin



  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event   [ Time Frame: Up to 12 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 Weeks 1, 2, 4, 6, 8, 10, and 12   [ Time Frame: Weeks 1, 2, 4, 6, 8, 10, and 12 ]

5.  Secondary:   Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8   [ Time Frame: Baseline; Weeks 1, 2, 4, 6, and 8 ]

6.  Secondary:   Percentage of Participants With Virologic Failure   [ Time Frame: Up to Posttreatment Week 24 ]

7.  Secondary:   Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment   [ Time Frame: Weeks 4, 8, and 12 ]

8.  Secondary:   Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24   [ Time Frame: Baseline; Week 12, Posttreatment Weeks 12 and 24 ]

9.  Secondary:   For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)   [ Time Frame: Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy ]

10.  Secondary:   For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24   [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy ]

11.  Secondary:   For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8   [ Time Frame: Baseline; Weeks 2, 4, and 8 of Retreatment Substudy ]

12.  Secondary:   For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure   [ Time Frame: Up to Posttreatment Week 24 of Retreatment Substudy ]


  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
e-mail: ClinicalTrialDisclosures@gilead.com


Publications of Results:
Cooper C, Naggie S, Saag M, Yang JC, Stamm LM, Dvory-Sobol H, et al. Retreatment of Patients Who Failed 12 Weeks of Ledipasvir/Sofosbuvir-Based Regimens with Ledipasvir/Sofosbuvir with Ribavirin for 24 Weeks [Poster Presentation]. 23nd Conference on Retroviruses and Opportunistic Infections (CROI); 2016 February 22-25; Boston, MA.
Naggie S, Cooper C, Saag M, Stamm LM, Yang JC, Pang PS, et al. Ledipasvir/Sofosbuvir for 12 Weeks in Patients Coinfected With HCV and HIV-1 [Oral Presentation]. 22nd Conference on Retroviruses and Opportunistic Infections (CROI); 2015 February 23-26; Seattle, WA.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02073656     History of Changes
Other Study ID Numbers: GS-US-337-0115
Study First Received: February 25, 2014
Results First Received: August 30, 2016
Last Updated: August 30, 2016