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

Primary Purpose

Chronic Hepatitis C Virus

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LDV/SOF

RBV

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Virus focused on measuring 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

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

LDV/SOF 8 Weeks (TN)

LDV/SOF+RBV 8 Weeks (TN)

LDV/SOF 12 Weeks (TN)

LDV/SOF 12 Weeks (TE)

LDV/SOF+RBV 12 Weeks (TE)

Arm Description

Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks.

Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks.

Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks.

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.

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.

Outcomes

Primary Outcome Measures

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

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.

Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.

Secondary Outcome Measures

Percentage of Participants With SVR 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 Viral Breakthrough or Viral Relapse

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.

Full Information

NCT ID

NCT01726517

First Posted

November 10, 2012

Last Updated

October 19, 2018

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01726517

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

January 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 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.

6. Conditions and Keywords

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

Chronic Hepatitis C Virus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDV/SOF 8 Weeks (TN)

Arm Type

Experimental

Arm Description

Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks.

Arm Title

LDV/SOF+RBV 8 Weeks (TN)

Arm Type

Experimental

Arm Description

Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks.

Arm Title

LDV/SOF 12 Weeks (TN)

Arm Type

Experimental

Arm Description

Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks.

Arm Title

LDV/SOF 12 Weeks (TE)

Arm Type

Experimental

Arm Description

Arm Title

LDV/SOF+RBV 12 Weeks (TE)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

LDV/SOF

Other Intervention Name(s)

Harvoni®

Intervention Description

LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily

Intervention Type

Drug

Intervention Name(s)

RBV

Intervention Description

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)

Primary Outcome Measure Information:

Title

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

Description

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.

Time Frame

Posttreatment Week 12

Title

Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

Description

The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.

Time Frame

Baseline to Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants With SVR 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 Viral Breakthrough or Viral Relapse

Description

Time Frame

Baseline to Posttreatment Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rob Hyland

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

Citations:

PubMed Identifier

24209977

Citation

Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, Symonds WT, McHutchison JG, Membreno FE. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014 Feb 8;383(9916):515-23. doi: 10.1016/S0140-6736(13)62121-2. Epub 2013 Nov 5. Erratum In: Lancet. 2014 Mar 8;383(9920):870.

Results Reference

derived

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

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