Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

Hepatitis C Virus Infection Clinical Trial

Official title:

A Phase 2 Open- Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naïve Patients With Chronic HCV Genotype 3 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413593
• Other study ID #: GS-US-337-1701
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: December 2016
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Chronic genotype 3 HCV infection

• HCV treatment-naive

• HCV RNA > 10,000 IU/mL at screening

• Absence of cirrhosis or compensated cirrhosis

• Screening laboratory values within defined thresholds

• Use of two effective contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner

• Coinfection with HIV or hepatitis B virus (HBV)

• Current or prior history of clinical hepatic decompensation

• Chronic use of systemic immunosuppressive agents

• History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• LDV/SOF
90/400 mg FDC tablet administered orally once daily
• RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Feld JJ, Ramji A, Shafran S, Willems B, Marotta P, Huchet E, et al. Ledipasvir/Sofosbuvir with ribavirin for 12 Weeks is effective and safe in treatment-naïve genotype 3 HCV-infected patients in Canada [Abstract SAT-183]. Presented at: The 51st Annual Con

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 HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12		Weeks 1, 2, 4, 8, and 12
Secondary	Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12		Baseline; Weeks 1, 2, 4, 8, and 12
Secondary	Percentage of Participants With 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 12