Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection

Phase 3

Completed

• Conditions: Hepatitis C Virus Infection
• Interventions: Drug: LDV/SOF; Drug: SOF; Drug: RBV

• Registration Number: NCT02738333
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-11
• Study Start: 2016-04-12
• Study First Posted: 2016-04-14
• Primary Completion: 2017-02-14
• Study Completion: 2017-05-11
• Status Verified: 2018-02
• Results First Submitted: 2018-02-12
• Results First Submitted QC: 2018-02-12
• Results First Posted: 2018-03-14
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

• Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females
• Aged 20 years or older
• Treatment naive or treatment experienced
• At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.

Key

Exclusion Criteria

• Previous exposure to an NS5A or NS5B inhibitor
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Pregnant or nursing female or male with pregnant female partner

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDV/SOF (Cohort 1)	LDV/SOF	LDV/SOF FDC for 12 weeks
SOF+RBV (Cohort 1)	SOF	SOF+RBV for 12 weeks
SOF+RBV (Cohort 1)	RBV	SOF+RBV for 12 weeks
LDV/SOF (Cohort 2)	LDV/SOF	Participants who are ineligible for or intolerant to RBV therapy will receive LDV/SOF FDC for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HCV RNA < LLOQ at Week 6	Week 6
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	Posttreatment Week 4	SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)	Posttreatment Week 24	SVR 24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ at Week 1	Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 2	Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 3	Week 3
Percentage of Participants With HCV RNA < LLOQ at Week 4	Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 5	Week 5
Percentage of Participants With HCV RNA < LLOQ at Week 8	Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 10	Week 10
Percentage of Participants With HCV RNA < LLOQ at Week 12	Week 12
Change From Baseline in HCV RNA at Week 1	Baseline; Week 1
Change From Baseline in HCV RNA at Week 2	Baseline; Week 2
Change From Baseline in HCV RNA at Week 3	Baseline; Week 3
Change From Baseline in HCV RNA at Week 4	Baseline; Week 4
Change From Baseline in HCV RNA at Week 5	Baseline; Week 5
Change From Baseline in HCV RNA at Week 6	Baseline; Week 6
Change From Baseline in HCV RNA at Week 8	Baseline; Week 8
Change From Baseline in HCV RNA at Week 10	Baseline; Week 10
Change From Baseline in HCV RNA at Week 12	Baseline; Week 12
Percentage of Participants With Overall 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.