Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

NCT02081079 | Completed Phase 2 Results

• 2 other identifiers: GS-US-337-11192013-003978-27
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 5

Brief Summary

This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.

Conditions

Chronic Genotype 4 HCV; Chronic Genotype 5 HCV

Keywords

HCV GT 4; HCV GT 5

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) at 12 weeks after stopping study treatment.

  Posttreatment Week 12

• Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event

  Up to 12 weeks

Secondary Outcomes (3)

• Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

  Posttreatment Weeks 4 and 24

• Percentage of Patients With Virologic Failure

  Up to posttreatment Week 24

• Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12

  Baseline; Weeks 2, 4, 8, and 12

Study Arms (2)

Genotype 4

EXPERIMENTAL

LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection

Drug: LDV/SOF

Genotype 5

EXPERIMENTAL

LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection

Drug: LDV/SOF

Interventions

LDV/SOF DRUG

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

Also known as: Harvoni®, GS-5885/GS-7977

Genotype 4; Genotype 5

Eligibility Criteria

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

You may qualify if:

• HCV RNA ≥ 10\^4 IU/mL at screening
• Chronic genotype 4 or 5 HCV Infection
• Individuals may be treatment naive or treatment experienced
• Presence or absence of cirrhosis, a liver biopsy may be required
• Healthy according to medical history and physical examination with the exception of HCV diagnosis
• Agree to use two forms of highly effective contraception for the duration of the study

You may not qualify if:

• History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
• Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
• History of any other clinically significant chronic liver disease
• Evidence of or history of decompensated liver disease
• HIV or chronic hepatitis B (HBV) infection
• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
• Chronic use of immunosuppressive agents or immunomodulatory agents

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (5)

Unknown Facility

Clermont-Ferrand, 63003, France

Location

Unknown Facility

Clichy, 92110, France

Location

Unknown Facility

Limoges, 87042, France

Location

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Villejuif, 94800, France

Location

Related Publications (2)

• Abergel A, Metivier S, Samuel D, Jiang D, Kersey K, Pang PS, Svarovskaia E, Knox SJ, Loustaud-Ratti V, Asselah T. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection. Hepatology. 2016 Oct;64(4):1049-56. doi: 10.1002/hep.28706. Epub 2016 Jul 29.

  PMID: 27351341 DERIVED

• Abergel A, Asselah T, Metivier S, Kersey K, Jiang D, Mo H, Pang PS, Samuel D, Loustaud-Ratti V. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 study. Lancet Infect Dis. 2016 Apr;16(4):459-64. doi: 10.1016/S1473-3099(15)00529-0. Epub 2016 Jan 21.

  PMID: 26803446 DERIVED

MeSH Terms

Interventions

ledipasvir, sofosbuvir drug combination

Limitations and Caveats

There were no limitations affecting the analysis or results.

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Kathryn Kersey, MSc

  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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 7, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: November 19, 2018
• Results First Posted: January 14, 2016

Record last verified: 2016-04

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

FR (5)