Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

Chronic Hepatitis C Virus Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701401
• Other study ID #: GS-US-337-0102
• Secondary ID: 2012-003387-43
• Status: Completed
• Phase: Phase 3
• Start date: September 2012
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 870
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18, with chronic genotype 1 HCV infection

• HCV treatment-naive

• HCV RNA > 10,000 IU/mL at screening

• Cirrhosis determination; a liver biopsy may be required

• Screening laboratory values within defined thresholds

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

Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner

• Co-infection with HIV or hepatitis B virus (HBV)

• Current or prior history of clinical hepatic decompensation

• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)

• Chronic use of systemic immunosuppressive agents

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

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
• RBV
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

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)	SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug.	Posttreatment Week 12
Primary	Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug	The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.	Up to 24 weeks
Secondary	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug	SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.	Posttreatment Weeks 4 and 24
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 2		Week 2
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 4		Week 4
Secondary	Percentage of Participants With HCV RNA < LLOQ at Week 8		Week 8
Secondary	Change From Baseline in HCV RNA at Week 2		Baseline; Week 2
Secondary	Change From Baseline in HCV RNA at Week 4		Baseline; Week 4
Secondary	Change From Baseline in HCV RNA at Week 8		Baseline; Week 8
Secondary	Percentage of Participants With Virologic Failure	On-treatment virologic failure was defined as: Breakthrough: HCV RNA = LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR; Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR; Nonresponse: HCV RNA persistently = LLOQ through 8 weeks of treatment; Virologic relapse was defined as HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement	Baseline to posttreatment Week 24