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

NCT01984294 | Completed Phase 2 Results

• 1 other identifier: GS-US-337-0133
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Posttreatment Week 12

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

  Up to 8 weeks

Secondary Outcomes (3)

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

  Posttreatment Weeks 2, 4, 8, and 24

• Percentage of Participants Experiencing On-treatment Virologic Failure

  Up to 8 weeks

• Percentage of Participants Experiencing Viral Relapse

  Up to Posttreatment Week 24

Study Arms (3)

LDV/SOF+RBV

EXPERIMENTAL

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

Drug: LDV/SOF; Drug: RBV

LDV/SOF + GS-9669 250 mg

EXPERIMENTAL

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

Drug: LDV/SOF; Drug: GS-9669

LDV/SOF + GS-9669 500 mg

EXPERIMENTAL

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

Drug: LDV/SOF; Drug: GS-9669

Interventions

LDV/SOF DRUG

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

Also known as: GS-7977/GS-5885

LDV/SOF + GS-9669 250 mg; LDV/SOF + GS-9669 500 mg; LDV/SOF+RBV

RBV DRUG

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)

Also known as: Ribasphere®

LDV/SOF+RBV

GS-9669 DRUG

GS-9669 tablet(s) administered orally once daily

LDV/SOF + GS-9669 250 mg; LDV/SOF + GS-9669 500 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Unknown Facility

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Interventions

Ribavirin; GS-9669

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Rob Hyland, DPhil

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 14, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 19, 2018
• Results First Posted: May 21, 2015

Record last verified: 2015-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

US (1)