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Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01726517
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : November 17, 2014
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Virus Drug: LDV/SOF Drug: RBV Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection
Study Start Date : October 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LDV/SOF 8 Weeks (TN)
Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks.
 Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Name: Harvoni®
Experimental: LDV/SOF+RBV 8 Weeks (TN)
Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks.
 Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Name: Harvoni®

Drug: RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Experimental: LDV/SOF 12 Weeks (TN)
Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks.
 Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Name: Harvoni®
Experimental: LDV/SOF 12 Weeks (TE)
Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks.
 Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Name: Harvoni®
Experimental: LDV/SOF+RBV 12 Weeks (TE)
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks.
 Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Name: Harvoni®

Drug: RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.

  2. Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [ Time Frame: Baseline to Week 12 ]
    The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.


Secondary Outcome Measures :
  1. Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24) [ Time Frame: Posttreatment Weeks 2, 4, 8, and 24 ]
    SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.

  2. Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse [ Time Frame: Baseline to Posttreatment Week 24 ]
    • Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
    • Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years, with chronic genotype 1 HCV infection
  • HCV RNA equal to or greater than 10,000 IU/mL at screening
  • Cirrhosis determination; a liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner
  • Current or prior history of clinical hepatic decompensation
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of systemic immunosuppressive agents
  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726517


Locations
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United States, Texas
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Rob Hyland Gilead Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01726517    
Other Study ID Numbers: GS-US-337-0118
First Posted: November 15, 2012    Key Record Dates
Results First Posted: November 17, 2014
Last Update Posted: November 16, 2018
Last Verified: November 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency
Keywords provided by Gilead Sciences:
HCV genotype 1 (GT-1)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
GS-7977
GS-5885
 Ribavirin
Open Label
Sofosbuvir
Treatment-Naïve
Protease Inhibitors
PI
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
 Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents