Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection

Phase 3

Completed

• Conditions: Chronic HCV Infection
• Interventions: Drug: LDV/SOF

• Registration Number: NCT02021656
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-12-10
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Primary Completion: 2017-07-08
• Study Completion: 2017-09-29
• Results First Submitted: 2018-07-03
• Results First Submitted QC: 2018-07-03
• Results First Posted: 2018-12-28
• Status Verified: 2019-01
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

• Willing and able to provide written informed consent
• HCV RNA ≥ 10^4 IU/mL at screening
• HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.
• Genotype 1 HCV at screening
• HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

Key

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Exclusion Criteria

• Pregnant or nursing female
• Chronic liver disease of a non-HCV etiology
• Current or prior history of any clinically-significant illness (other than HCV)
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LDV/SOF	LDV/SOF	Treatment-experienced and treatment-naive participants will receive LDV/SOF for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 25 IU/mL in Korea and Taiwan and \< 15 IU/mL in China) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Percentage of Participants Experiencing Viral Relapse	Week 12 to Posttreatment Week 24	Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.
HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only	Baseline; Week 12
Percentage of Participants Experiencing Viral Breakthrough	Up to 12 weeks	Viral breakthrough were defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) during treatment, but did not achieve a sustained virologic response (SVR).