Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection

Phase 3

Completed

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

• Registration Number: NCT01975675
• Lead Sponsor: Gilead Sciences

Brief Summary

This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-10-29
• Study First Posted: 2013-11-05
• Primary Completion: 2014-06
• Study Completion: 2014-08
• Status Verified: 2015-06
• Results First Submitted: 2015-06-04
• Results First Submitted QC: 2015-06-04
• Results First Posted: 2015-06-26
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

• Body weight ≥ 40 kg
• HCV RNA ≥ 10^5 IU/mL at screening

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDV/SOF+RBV (treatment experienced)	LDV/SOF	Treatment-experienced participants will receive LDV/SOF plus RBV for 12 weeks.
LDV/SOF (treatment naive)	LDV/SOF	Treatment-naive participants will receive LDV/SOF for 12 weeks.
LDV/SOF+RBV (treatment naive)	LDV/SOF	Treatment-naive participants will receive LDV/SOF plus RBV for 12 weeks.
LDV/SOF (treatment experienced)	LDV/SOF	Treatment-experienced participants will receive LDV/SOF for 12 weeks.
LDV/SOF+RBV (treatment naive)	RBV	Treatment-naive participants will receive LDV/SOF plus RBV for 12 weeks.
LDV/SOF+RBV (treatment experienced)	RBV	Treatment-experienced participants will receive LDV/SOF plus RBV for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 12 weeks
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants With Sustained Virologic Response at 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) at 12 weeks after stopping study treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Virologic Failure	Up to Posttreatment Week 24	Virologic failure was defined as; 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); Virologic relapse: - Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
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 SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.