SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Humanity and Health Research Centre106 enrolled

Overview

For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.

Chinese genotype 1b HCV treatment-experienced cirrhotic patients are recruited and treated with 12 weeks sofosbuvir 400 mg daily plus daclatasvir 60 mg daily. At baseline, liver stiffness measurement (LSM) using transient elastography (FibroScan®) is used to assess liver fibrosis and the single nucleotide polymorphism ofinterferon-λ 3 (IL-28, rs12979860, C or T) and IFLN4 (ss469415590, TT or ΔG) is determined. Serial measurement of plasma HCV RNA levels are performed with the use of the COBAS TaqMan real-time assay (Roche version 2.0), at baseline, Day 2,4 and 7, week 2,4 and 12, post-treatment week 12. The primary efficacy end point is a sustained virologic response 12 weeks after the end of treatment (SVR12).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Chronic Hepatitis C Infection

Interventions

SofosbuvirDRUG

Sofosbuvir 400 mg tablet administered once daily

DaclatasvirDRUG

Daclatasvir 60mg tablet administered once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients chronically infected with HCV Genotype-1b; 2. Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin; 3. HCV RNA level greater than 10,000 IU/ml at screening; 4. Patients with compensated cirrhosis are permitted. Exclusion Criteria: 1. Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded; 2. Screening ECG with clinically significant abnormalities; 3. Laboratory results outside of acceptable ranges at screening; 4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

Locations (2)

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital

Beijing, Beijing Municipality, China

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, China

Outcomes

Primary Outcomes

Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12)

SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug

Time frame: Post treatment Week 12

Data from ClinicalTrials.gov

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