Clinical trial NCT02065999: Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
Official title: Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C, chronic
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: The University of New South Wales
name: Merck Sharp & Dohme LLC
First posted: 2014-02-19
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An anticipated 100 participants will be recruited from 2 study sites: St Vincent's Hospital, Sydney; St Vincent's Hospital, Melbourne.

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.

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

Primary outcomes:
measure: Prevalence of HCV resistance associated variants (RAVs) and the incidence of RAVs arising during therapy.
timeFrame: Baseline
Secondary outcomes:
measure: Factors associated with treatment failure due to virological breakthrough / relapse.
timeFrame: Baseline
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
Study officials:
affiliation: The University of New South Wales
name: Gail Dr Matthews, MBChB, MRCP (UK), FRACP, PhD
role: PRINCIPAL_INVESTIGATOR
References: