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Trial record 2 of 5 for:    GS-9669
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Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection

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ClinicalTrials.gov Identifier: NCT01984294
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : May 21, 2015
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).

Condition or disease Intervention/treatment Phase
Chronic HCV Infection Drug: LDV/SOF Drug: RBV Drug: GS-9669 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 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/Ledipasvir Fixed-Dose Combination With Ribavirin or GS-9669 250 mg or GS-9669 500 mg in Naive or Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C

Arms and Interventions
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Arm Intervention/treatment
Experimental: LDV/SOF+RBV
Participants will receive LDV/SOF plus RBV for 8 weeks.
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily
Other Name: GS-7977/GS-5885

Drug: RBV
Ribavirin (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)
Other Name: Ribasphere®
Experimental: LDV/SOF + GS-9669 250 mg
Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks.
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily
Other Name: GS-7977/GS-5885

Drug: GS-9669
GS-9669 tablet(s) administered orally once daily
Experimental: LDV/SOF + GS-9669 500 mg
Participants will receive LDV/SOF plus GS-9669 500 mg (2 x 250 mg) for 8 weeks.
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily
Other Name: GS-7977/GS-5885

Drug: GS-9669
GS-9669 tablet(s) administered orally once daily


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 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, 15 IU/mL) 12 weeks following the last dose of study drug.

  2. Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event [ Time Frame: Up to 8 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 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 On-treatment Virologic Failure [ Time Frame: Up to 8 weeks ]

    On-treatment virologic failure was defined as

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

  3. Percentage of Participants Experiencing Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ]
    Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.


Eligibility Criteria
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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, with chronic genotype 1 HCV infection
  • Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen
  • HCV RNA > 10,000 IU/mL at Screening
  • Presence of compensated cirrhosis
  • 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
  • Co-infection with HIV or hepatitis B virus (HBV)
  • Current or prior history of clinical hepatic decompensation
  • 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): NCT01984294


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, DPhil Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01984294    
Other Study ID Numbers: GS-US-337-0133
First Posted: November 14, 2013    Key Record Dates
Results First Posted: May 21, 2015
Last Update Posted: November 19, 2018
Last Verified: April 2015
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
HCV
Sustained Virologic Response
Direct-Acting Antiviral
Combination Therapy
GS-7977
GS-5885
Ribavirin
 Open Label
Sofosbuvir
Treatment-Naive
Protease Inhibitors
PI
Treatment experienced
Cirrhotic
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis C
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
 RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action