Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients

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.

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Key information

Conditions

Chronic Hepatitis C Infection Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Vincent's Hospital, Sydney, New South Wales, Australia

About this study

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.
To determine whether in the absence of drug pressure there is variation in the prevalence of naturally occurring resistance associated variants.
To correlate the presence and frequency of baseline resistance-associated variants with the response to therapy with DAA-based triple therapy regimens for HCV.
To identify predictors of emergent DAA resistance and treatment failure during therapy with DAA-based combination strategies, including virological, clinical and immunological factors.
To characterize the natural history of HCV resistance associated variants that are selected during antiviral therapy after the withdrawal of treatment.
To establish a cohort of DAA-treatment failure patients suitable for re-treatment studies.
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Prevalence of HCV resistance associated variants (RAVs) and the incidence of RAVs arising during therapy.

Time frame: Baseline

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.

Secondary outcomes

Factors associated with treatment failure due to virological breakthrough / relapse.

Time frame: Baseline

Multivariable logistic regression modelling with backwards elimination will be used to identify factors associated with this.

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

Merck Sharp & Dohme LLC
The University of New South Wales

Registry information

Acronym: SEARCH-C

Important dates

Study start: 2012
Primary completion: 2022
Study completion: 2022
First posted: Feb 19, 2014
Registry last updated: Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed