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

Hepatitis C Virus Infection Clinical Trial

Official title:

A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738333
• Other study ID #: GS-US-337-1903
• Status: Completed
• Phase: Phase 3
• Start date: April 12, 2016
• Est. completion date: May 11, 2017

Study information

• Verified date: February 2018
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: May 11, 2017
• Est. primary completion date: February 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Key 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Virus Diseases

Intervention

Drug:
• LDV/SOF
90/400 mg FDC tablet administered orally once daily
• SOF
400 mg tablet administered orally once daily
• RBV
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (= 60 kg = 600 mg, > 60 kg to = 80 kg = 800 mg, and > 80 kg = 1000 mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to 12 weeks
Secondary	Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.	Posttreatment Week 4
Secondary	Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)	SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.	Posttreatment Week 24
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 1		Week 1
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 2		Week 2
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 3		Week 3
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 4		Week 4
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 5		Week 5
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 6		Week 6
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 8		Week 8
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 10		Week 10
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 12		Week 12
Secondary	Change From Baseline in HCV RNA at Week 1		Baseline; Week 1
Secondary	Change From Baseline in HCV RNA at Week 2		Baseline; Week 2
Secondary	Change From Baseline in HCV RNA at Week 3		Baseline; Week 3
Secondary	Change From Baseline in HCV RNA at Week 4		Baseline; Week 4
Secondary	Change From Baseline in HCV RNA at Week 5		Baseline; Week 5
Secondary	Change From Baseline in HCV RNA at Week 6		Baseline; Week 6
Secondary	Change From Baseline in HCV RNA at Week 8		Baseline; Week 8
Secondary	Change From Baseline in HCV RNA at Week 10		Baseline; Week 10
Secondary	Change From Baseline in HCV RNA at Week 12		Baseline; Week 12
Secondary	Percentage of Participants With Overall Virologic Failure	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.	Up to Posttreatment Week 24