Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients

NCT ID: NCT02065999

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2022-06-30

Brief 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.

Detailed 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.

Conditions

Chronic Hepatitis C Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of New South Wales

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Kirby Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Dr Matthews, MBChB, MRCP (UK), FRACP, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of New South Wales

Locations

St Vincent's Hospital

Sydney, New South Wales, Australia

St Vincent's Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

VHCRP1107

Identifier Type: -

Identifier Source: org_study_id