SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

Humanity and Health Research Centre

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: Sofosbuvir; Drug: Daclatasvir

Study type: Interventional

Funder types: Other

Identifiers

NCT02473211

H&H_SOF plus DCV treatment

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

SOF+DCV

Experimental group

Description:

Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.

Treatment:

Drug: Daclatasvir

Drug: Sofosbuvir