Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects

Gilead Sciences100 enrolled

Overview

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Chronic Hepatitis C Virus

Interventions

LDV/SOFDRUG

LDV 90 mg/SOF 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 years, with chronic genotype 1 HCV infection * HCV RNA equal to or greater than 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 * 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 (1)

Unnamed facility

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.

Time frame: Baseline to Week 12

Secondary Outcomes

Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)

SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA \< LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.

Time frame: Posttreatment Weeks 2, 4, 8, and 24

Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse

* Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values. * Viral 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

Data from ClinicalTrials.gov

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