Switching Regimen in Treating Cirrhotic HCV GT1b Subjects

Humanity and Health Research Centre138 enrolled

Overview

This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

138

Conditions

Chronic Hepatitis C Infection

Interventions

PR4 + LDV/SOF + ASV 4 wkDRUG

Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.

PR4 + LDV/SOF + SMV 4 wkDRUG

PR4 + LDV/SOF + ASV 6 wk

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals with chronic HCV GT1b infection; * HCV RNA ≥ 10000 IU/mL at screening; * Received 4 weeks pegylated interferon plus ribavirin (PR4) therapy and are intolerant to PR4; * Cirrhosis determination; a liver biopsy may be required; * Use of highly effective contraception methods if female of childbearing potential or sexually active male; Exclusion Criteria: * Pregnant or nursing female or male with pregnant female partner; * HIV or HBV co-infection; * Hematologic or biochemical parameters at Screening outside the protocol- specified requirements; * Active or recent history (≤ 1 year) of drug or alcohol abuse; * History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

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 (SVR12) after discontinuation of therapy

SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.

Time frame: Post treatment Week 12

Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)

Time frame: Baseline up to Week 24

Secondary Outcomes

Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment

Time frame: Baseline up to Week 24

Treatment adherence

To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)

Time frame: Baseline to Week 12

Change in health related quality of life evaluated with questionnaires

To evaluate the change in health-related quality of life during and after treatment with questionnaires

Time frame: Up to Posttreatment Week 24

Change in mental health evaluated with questionnaires

To evaluate the change in mental health during and after treatment with questionnaires

Time frame: Up to Posttreatment Week 24

Liver disease progression

Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.

Data from ClinicalTrials.gov

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