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Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection

Primary Purpose

Chronic HCV Infection

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LDV/SOF

RBV

GS-9669

About this trial

This is an interventional treatment trial for Chronic HCV Infection focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

LDV/SOF+RBV

LDV/SOF + GS-9669 250 mg

LDV/SOF + GS-9669 500 mg

Arm Description

Participants will receive LDV/SOF plus RBV for 8 weeks.

Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks.

Participants will receive LDV/SOF plus GS-9669 500 mg (2 x 250 mg) for 8 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

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.

Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)

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.

Percentage of Participants Experiencing On-treatment Virologic Failure

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)

Percentage of Participants Experiencing Viral Relapse

Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.

Full Information

NCT ID

NCT01984294

First Posted

November 8, 2013

Last Updated

October 19, 2018

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01984294

Brief Title

Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection

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 Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic HCV Infection

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDV/SOF+RBV

Arm Type

Experimental

Arm Description

Participants will receive LDV/SOF plus RBV for 8 weeks.

Arm Title

LDV/SOF + GS-9669 250 mg

Arm Type

Experimental

Arm Description

Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks.

Arm Title

LDV/SOF + GS-9669 500 mg

Arm Type

Experimental

Arm Description

Participants will receive LDV/SOF plus GS-9669 500 mg (2 x 250 mg) for 8 weeks.

Intervention Type

Drug

Intervention Name(s)

LDV/SOF

Other Intervention Name(s)

GS-7977/GS-5885

Intervention Description

Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily

Intervention Type

Drug

Intervention Name(s)

RBV

Other Intervention Name(s)

Ribasphere®

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

GS-9669

Intervention Description

GS-9669 tablet(s) administered orally once daily

Primary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

Description

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.

Time Frame

Posttreatment Week 12

Title

Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event

Time Frame

Up to 8 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)

Description

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.

Time Frame

Posttreatment Weeks 2, 4, 8, and 24

Title

Percentage of Participants Experiencing On-treatment Virologic Failure

Description

Time Frame

Up to 8 weeks

Title

Percentage of Participants Experiencing Viral Relapse

Description

Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.

Time Frame

Up to Posttreatment Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rob Hyland, DPhil

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing URL

http://www.gilead.com/research/disclosure-and-transparency

Learn more about this trial

Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection

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