Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy

Gilead Sciences19 enrolled

Overview

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer chemotherapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Virus Infection

Interventions

LDV/SOFDRUG

Tablet(s) administered orally once daily

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Aged 12 to \<18 years * Parent or legal guardian must provide written informed consent * Treatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on a maintenance cancer chemotherapy regimen * Receiving a protocol-approved maintenance chemotherapy regimen for a hematological malignancy * Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy * Screening laboratory values within defined thresholds * No History of solid organ or bone marrow transplantation * No history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage) NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Locations (1)

National Cancer Institute, Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

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, 50 IU/mL) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

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

Time frame: First dose date up to Week 12

Secondary Outcomes

Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)

SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.

Time frame: Posttreatment Week 4

Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)

SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.

Time frame: Posttreatment Week 24

Percentage of Participants With HCV RNA < LLOQ While on Treatment

Time frame: Weeks 1, 4, 8, and 12

HCV RNA Change From Baseline/Day 1

Time frame: Baseline; Weeks 1, 4, 8, and 12

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

Data from ClinicalTrials.gov

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