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

Phase 2

Completed

• Conditions: Chronic Genotype 5 HCV; Chronic Genotype 4 HCV
• Interventions: Drug: LDV/SOF

• Registration Number: NCT02081079
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-07
• Primary Completion: 2014-11
• Study Completion: 2015-02
• Disposition First Submitted: 2015-10-21
• Disposition First Submitted QC: 2015-10-21
• Disposition First Posted: 2015-10-27
• Results First Submitted: 2015-12-10
• Results First Submitted QC: 2015-12-10
• Results First Posted: 2016-01-14
• Status Verified: 2016-04
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genotype 4	LDV/SOF	LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection
Genotype 5	LDV/SOF	LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event	Up to 12 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12	Baseline; Weeks 2, 4, 8, and 12
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Patients With Virologic Failure	Up to posttreatment Week 24	Virologic failure was defined as either: * On-treatment virologic failure: * 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); or; * Relapse: * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment