Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
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.
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.
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