Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients

Chronic Hepatitis C Infection Clinical Trial

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Official title:

Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065999
• Other study ID #: VHCRP1107
• Status: Completed
• Start date: November 2012
• Est. completion date: June 2022

Study information

• Verified date: March 2024
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multi-centre prospective longitudinal cohort study with the aim of collecting and storing clinical data, patient blood, DNA and PBMCs to examine outcomes related to drug resistance, drug monitoring and host genetics in the era of directly acting antiviral drugs for hepatitis C therapy.

Description:

1. To analyse for resistance-associated HCV variants in DAA-naïve HCV patients using population and ultra-deep pyrosequencing (UDPS). Resistance associated variants will be analysed by qualitative and quantitative methods both pre-treatment and on-treatment. 2. To determine whether in the absence of drug pressure there is variation in the prevalence of naturally occurring resistance associated variants. 3. To correlate the presence and frequency of baseline resistance-associated variants with the response to therapy with DAA-based triple therapy regimens for HCV. 4. To identify predictors of emergent DAA resistance and treatment failure during therapy with DAA-based combination strategies, including virological, clinical and immunological factors. 5. To characterize the natural history of HCV resistance associated variants that are selected during antiviral therapy after the withdrawal of treatment. 6. To establish a cohort of DAA-treatment failure patients suitable for re-treatment studies. 7. To establish a tissue repository of serum and PBMCs from well-characterized patients treated with DAA-based triple therapy to allow future examination of the role of other variables that may potentially impact on the outcomes of DAA based therapy and development of RAVs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Chronic hepatitis C infection
• Commencing or expected to commence DAA-based HCV treatment within the next year
• IFN treatment-naïve or IFN treatment-experienced
• Provision of written, informed consent

Exclusion Criteria:

• In the opinion of the investigator that the patient is not able to provide informed consent
• Inability or unwillingness to comply with study collection requirements

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Melbourne	Victoria
Australia	St Vincent's Hospital	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
Kirby Institute	Merck Sharp & Dohme LLC, The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of HCV resistance associated variants (RAVs) and the incidence of RAVs arising during therapy.	Descriptive statistics will be used to describe RAVs using standard international nomenclature and presented in table form. Baseline clinical and demographic data on subjects will be presented, as will rates of treatment failure and reasons for failure.	Baseline
Secondary	Factors associated with treatment failure due to virological breakthrough / relapse.	Multivariable logistic regression modelling with backwards elimination will be used to identify factors associated with this.	Baseline