Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong
Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong
In the current era of highly effective direct acting antiviral (DAA) therapy, the remaining
 obstacles to elimination of chronic HCV infection are identification of the high-risk groups,
 linkage to continued care and prevention of re-infection. It is estimated that 70-80% of
 patients with chronic HCV are unaware of their infection. Besides, public health education is
 limited and most patients are not aware that the current standard-of-care is highly
 effective, well tolerated and no longer require weekly subcutaneous injections. From a survey
 in Hong Kong in 2014, among 234 newly diagnosed HCV patients, only 20% agreed to undergo
 treatment. There is no universal screening programme for chronic hepatitis C infection in
 Hong Kong. and known high-risk patients include people who inject drugs (PWID), persons with
 certain medical conditions including those on hemodialysis, HIV infected, those with prior
 transfusion or organ transplantation. In this study, the investigators plan to reach out to
 PWIDs in rehabilitation programs to provide rapid point-of-care screening for chronic
 hepatitis C infection, and to provide linkage to care for those diagnosed with chronic
 hepatitis C.
Existing data on HCV sero-prevalence in these patients in Hong Kong is however fragmented
 especially in non-hospitalized persons. From the year 2014 surveillance report prepared by
 Department of Health (DH), anti-HCV prevalence rate among PWID under DH's methadone clinics
 was 46.2%. Two major issues remain in view of the high seroprevalence rate in this subgroup.
 Firstly, HCV RNA positivity was not reported and it is unknown whether these patients are
 still chronically infected. Many of patients are not directed to subsequent confirmatory
 tests and if they are chronically infected, they need to be linked to care. Secondly, data
 does not exist for PWID who are receiving substance abuse counselling or rehabilitation
 treatment programs under agencies which are not run by DH or the Hong Kong Hospital
 Authority. These are run by non-governmental organizations (NGOs), such as Barnabas
 Charitable Service Association providing training centre and half-way house for residence,
 and religious organizations providing rehabilitation centres. These subjects belong to
 high-risk group of harbouring undiagnosed chronic HCV and thus should be tested and linked to
 care.

 Traditionally, the first step in screening for HCV utilizes enzyme immunoassay for the
 antibody against HCV. Fortunately, newer rapid diagnostic tests (RDT) can be used as a tool
 to screen subjects by providing point-of-care diagnosis on site. For instance, the OraQuick®
 HCV test (OraSure Technologies, Inc) is FDA-approved and CLIA-waived, with more than 98%
 sensitivity and specificity for qualitative detection of anti-HCV antibody in finger stick or
 venepuncture whole blood. As the volume of blood required is much smaller, subjects only need
 a finger stick for testing and results will be available within 20-40min. Subjects having
 positive results from RDT will proceed with venepuncture for collection of whole blood which
 will be sent back to our laboratory for confirmatory testing of anti-HCV antibody and HCV
 RNA.

 Upon confirmation of diagnosis, subjects should be linked to care for further management.
 Ideally, all patients with chronic HCV should be treated regardless of severity of liver
 disease unless liver decompensation has developed necessitating liver transplantation before
 treatment or limited lifespan is expected even with DAA treatment. In Hong Kong, due to
 limited health care resources and lack of comprehensive insurance coverage schemes, DAA
 cannot be universally prescribed to every patient. Risk stratification is the strategy
 adopted by the Hospital Authority to prioritize those patients with more advanced liver
 disease, as defined by advanced liver fibrosis (F3) or cirrhosis (F4), to receive subsidized
 DAA treatment. If all patients with different risk profiles are linked to care in the same
 manner, those with more advanced disease will suffer from delayed assessment and subsequent
 treatment due to the long waiting time (in terms of 1-2 years) to be seen by specialist. The
 investigators propose to set up an integrated linkage-to-care clinic for all patients with
 newly diagnosed chronic HCV. Patients will be assessed in a timely manner. A dedicated
 research nurse will provide counselling and education to the patients. The nurse will then
 arrange on-site liver stiffness measurement with Fibroscan®, as well as phlebotomy for liver
 function test assessment. Patients with F3/F4 or significantly impaired liver function shall
 be directed to specialist via a fast track protocol to facilitate timely treatment, instead
 of the routine clinic appointment.

 The mission of our department is to promote health in the field of Hepatology. The
 investigators have a team of dedicated professionals to provide high-quality services to
 patients in our community. Besides, our team actively participates in various kinds of
 liver-related basic science and clinical studies with numerous scientific contributions, and
 therefore is very experienced and well equipped with laboratory back up for liver-related
 research. The investigators have previously conducted a large-scale population-based study in
 10,256 Hong Kong subjects for detection of seroprevalence rates of viral hepatitis, which
 showed that sero-prevalence rate of HCV to be 0.5% in the general community. The
 investigators are determined to fill the knowledge gap of the rate of chronic HCV infection
 in high-risk groups.

 This is a prospective cohort study. The investigators will form an outreach team and conduct
 visits to the halfway house and rehabilitation centres run by non-governmental organisations
 (NGOs). The investigators will perform rapid diagnostic test (RDT) in these people who
 injected drugs (PWIDs) who have already started rehabilitation in these institutions. The
 investigators plan to conduct site visits every 4 - 8 weeks. The consent and potential impact
 of this study will be explained to subjects, followed by obtaining consent and blood taking.
 Subjects will also be asked to fill in a questionnaire, including information on age, gender,
 place of birth, ethnic origin, chronic medical illness, prior viral hepatitis infection,
 history of receiving HCV treatment and risk factors for contracting HCV (e.g. prior
 transfusion, intravenous drug use, tooth extraction or gum surgery, skin tattooing). Subjects
 will then have finger stick, which will be used for RDT as a point-of-care HCV screening
 test. If the RDT result is positive, the subject will then proceed with formal venepuncture
 for whole blood, which will be tested for confirmatory anti-HCV and HCV RNA (HCV genotype
 will also be determined for HCV RNA positive samples) in our own laboratory. The
 investigators will actively contact subjects confirmed with the diagnosis of chronic HCV. The
 research nurse will contact them to attend the integrated linkage-to-care clinic for
 counselling, education and risk stratification. During the clinic visits, risk stratification
 according to the liver status will be done by 1) physical examinations to document the
 clinical liver status, 2) comprehensive blood investigations including liver function tests,
 platelet counts and clotting profiles and 3) Fibroscan® to assess the fibrosis status.
Inclusion Criteria:

 -  People who inject drugs (PWID) who are receiving substance abuse counselling or
 rehabilitation treatment programs in halfway house and rehabilitation centres run by
 Non-governmental organisations (NGOs) in Hong Kong

 Exclusion Criteria:

 -  Already on antiviral therapy for known HCV