Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease

Phase 2CompletedNCT02301936

Gilead Sciences10 enrolled

Overview

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Virus Infection

Interventions

LDV/SOFDRUG

90/400 mg fixed dose combination (FDC) tablet administered orally once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Chronic genotype 1 or 4 infected patients with sickle cell disease * HCV RNA ≥ 1,000 IU/mL at screening * Cirrhosis determination by transient elastography * 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 * 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) * History of clinically significant illness or any other medical disorder that may interfere with treatment, assessment or compliance with the protocol Note: Other protocol defined inclusion/Exclusion criteria may apply.

Locations (1)

Unnamed facility

Lutherville, Maryland, United States

Outcomes

Primary Outcomes

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

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

Time frame: Posttreatment Week 12

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time frame: Up to 24 weeks

Secondary Outcomes

Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA \< the LLOQ 4 weeks following the last dose of study drug.

Time frame: Posttreatment Week 4

Percentage of Participants With HCV RNA < LLOQ on Treatment

Time frame: Weeks 1, 2, 4, 8,12, 16, 20, and 24

HCV RNA Change From Baseline

Time frame: Up to 24 weeks

Percentage of Participants With Virologic Failure

Virologic failure was defined as * On-treatment virologic failure * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment, * \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse) * Relapse * 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: Up to Posttreatment Week 12

Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score

Data from ClinicalTrials.gov

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