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

Gilead Sciences870 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

870

Conditions

Chronic Hepatitis C Virus

Interventions

LDV/SOFDRUG

LDV/SOF 90/400 mg FDC tablet administered orally once daily

RBVDRUG

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (88)

Outcomes

Primary Outcomes

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.

Time frame: Posttreatment Week 12

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.

Time frame: Up to 24 weeks

Secondary Outcomes

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.

Time frame: Posttreatment Weeks 4 and 24

Percentage of Participants With HCV RNA < LLOQ at Week 2

Time frame: Week 2

Percentage of Participants With HCV RNA < LLOQ at Week 4

Time frame: Week 4

Percentage of Participants With HCV RNA < LLOQ at Week 8

Time frame: Week 8

Change From Baseline in HCV RNA at Week 2

Time frame: Baseline; Week 2

Change From Baseline in HCV RNA at Week 4

Time frame: Baseline; Week 4

Change From Baseline in HCV RNA at Week 8

Data from ClinicalTrials.gov

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Unnamed facility

Birmingham, Alabama, United States

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La Jolla, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Aurora, Colorado, United States

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Englewood, Colorado, United States

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Washington D.C., District of Columbia, United States

...and 78 more locations

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

Time frame: Baseline to posttreatment Week 24