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Hepatitis B Research and Clinical Trials

Current Research Trials 

GSK Study

Chronic Hepatitis B (CHB) affects around 94,000 people in Aotearoa, especially Māori, Pacific, and Asian communities. While current treatments can reduce liver damage, they seldom result in a complete cure. Only a few people achieve what’s known as a ‘Functional Cure’ – where the virus is controlled without requiring ongoing therapy. This greatly lowers the risk of liver cancer and cirrhosis and improves long-term health.  

To help us better understand who might benefit from new treatments, HFNZ is supporting a research study being conducted by ICON plc, a clinical research organisation, with patients registered with HFNZ. This study is funded by GlaxoSmithKline (GSK), a pharmaceutical company developing new therapies for CHB. The results of this study will support GSK’s application to approve a new treatment in New Zealand called bepirovirsen, which is designed to help more people achieve a Functional Cure. These findings will be submitted to government agencies that assess whether medicines are safe and whether they can be publicly funded (e.g., Te Pātaka Whaioranga [PHARMAC]). The goal is to help make future CHB treatments more broadly available to people in Aotearoa.  

The study has been approved by the Health and Disabilities Ethics Committee of New Zealand.  The study will start on 24 November 2025 and finish on 31 July 2026. 

Study at a glance: 

  • Your participation will help us to identify patients who may be suitable for a cure for hepatitis B. 

  • If you wish to participate, you don’t need to do anything. 

  • You can opt-out at any time before the end of the study on 31 July 2026 or before your next blood test. Contact us as above to opt-out.  

  • No extra appointments or needles are required. 

  • The qHBsAg test will only be done once – at the same time as your next routine 6-monthly blood test, using the same blood sample. 

  • Your data will remain de-identified. 

  • You will receive your personal test result along with an explanation of what this result means. 

  • Your blood sample will be destroyed after batch testing per standard laboratory protocols.  

Download the GSK Study Patient Information Sheet

 

Questions about the study? Call us on 0800 33 22 10, or email us at hepteam@hfnz.nz  


Orbis Study

Hepatitis B Catch-Up Clinic — Whakatāne 

The Hepatitis Foundation of New Zealand is holding a special catch-up clinic for patients in the Eastern Bay of Plenty who are overdue for their regular liver monitoring blood tests.  Monitoring blood tests are important - they allow us to check for early signs of liver disease such as cirrhosis and liver cancer, which often have no symptoms until they are advanced. 

Clinic details 

Dates & times: 

  • Tuesday 23 June (9am - 5:30pm) 

  • Wednesday 24 June (8am – 5pm) 

  • Thursday 25 June (8am – 1:30pm) 

  • Location: Hepatitis Foundation, 61 Alexander Avenue, Whakatāne 

  • Nurse: Helen Purcell (Hepatitis Nurse) 

To book a space, call us on 0800 33 20 10 or email hepteam@hfnz.nz

Everyone who comes in for their blood test will receive a one-off $50 Pak n Save voucher as a thank you. 

Research study — TAP® Micro Select device Optional 

The Hepatitis Foundation is working with Orbis Diagnostics to trial a new blood collection device called the TAP® Micro Select. This is a research study - the device is not yet in standard use. 

The TAP® device collects a small sample of blood from the upper arm using a brief touch. It takes about 1–1.5 minutes, is virtually painless, and may leave a small ring mark or bruise. It tests for the same things as your regular blood test - Hepatitis B surface antigen, Hepatitis B antibodies, and Hepatitis B core antibody. 

We want to find out whether this device works as well as a standard blood draw. If it does, it could make regular monitoring easier for everyone living with HBV. 

Taking part in the study is entirely your choice. If you agree to take part, you will be asked to sign a consent form on the day. You can decide not to take part and your regular blood test and voucher will not be affected in any way. 

This clinic is only for your usual hepatitis monitoring - we are not testing for anything else. 

About Orbis Diagnostics and the study 

Orbis Diagnostics is a New Zealand company developing a new point-of-care blood test for Hepatitis B. The test — called the HBV Triplex Assay — can detect three key markers from a single small blood sample, telling us whether someone has an active HBV infection, a resolved infection, vaccine-induced immunity, or no immunity at all. The goal is to make quality HBV testing available in community settings, without needing a hospital or laboratory. 

The study is a research collaboration between Orbis Diagnostics and the University of Auckland, led by Professor Cather Simpson. The Hepatitis Foundation of New Zealand is a partner in recruiting participants. 

About the study 

The study is comparing two ways of collecting blood for the HBV Triplex Assay — a small microsampler device applied to the upper arm, and a standard venous blood draw. Researchers want to know whether both methods give the same results. If they do, the test could eventually be used in community clinics and other accessible settings without needing a trained phlebotomist. 

At your clinic visit you will provide two types of blood samples. The microsample is collected using the TAP® Micro Select device, which is pressed briefly against your upper arm — it takes about 1–1.5 minutes, is virtually painless, and may leave a small ring mark or bruise. A standard venous blood draw will also be taken. One venous sample will be tested by Orbis; a second will be sent to Awanui Laboratories using an established gold standard test (Roche Elecsys®) so the results can be compared. 

Your results from the Awanui gold standard test will be made available to you through your clinician. Results from the Orbis test will not be used for your clinical care at this stage, as the assay is still under development. 

The University of Auckland holds overall responsibility for the study, including participant safety and data privacy. All data is stored securely and in line with the New Zealand Privacy Act 2020. 

Download the Study Information Sheet

Download the Patient Consent Sheet

 

Questions about the study? Call us on 0800 33 22 10, or email us at hepteam@hfnz.nz  

Clinical trials

Many pharmaceutical companies are working on a cure for hepatitis B. These cures will target people living with chronic hepatitis B. The process includes clinical trials, which give patients a chance to get involved with developing a cure. 

The criteria for participating in these trials varies, so please check your eligibility with the clinical trial unit nearest you.

What is a clinical trial?

A clinical trial is a study that observes or treats patients to develop or discover new treatments or medications. It means scientists can accurately evaluate medications by studying their effects on healthy people and others who have the condition the drug is designed to target. 

Volunteer participants are vital to clinical trials. As a participant, your rights are paramount and will be respected. All trial operators will ensure prospective participants fully understand what's involved before giving consent.  

How can I get involved?

Please contact the clinical trial facility nearest you if you’re interested in being considered for trials or would like more information about what’s involved. It's also recommended you involve your doctor so you can make an informed decision.

People accepted into clinical trials may be reimbursed for their time, but this varies and is dependent on the trial. 

 

What organisations run clinical trials?

Facilities currently running clinical trials in New Zealand are:

NZCR - Auckland Clinical Studies 

Aotearoa Trials - Middlemore Clinical Trials Unit 

Health New Zealand Clinical Trials Units

Momentum Clinical Research (P3 Research) (NZ-wide) 

The “Rhythm” Clinical Trial

New Zealand Clinical Research (NZCR) is assessing the safety and effectiveness of Tune-401 – an investigational epigenetic gene silencing approach for the treatment of Chronic Hepatitis B.

Epigenetic gene silencing (also known as HBV viral silencing) are LNP-RNA drugs that bind to DNA and switch off target genes in order to treat illness and disease. They are a form of genetic medicine– related to gene editing, but different in that epigenetic proteins cannot and do not cut DNA or alter DNA sequence. Tune-401 targets HepB Virus DNA, and aims to switch off the genes essential for viral reproduction and infection.

Am I suitable for this trial? Are you…..

  • 18-75 years old

  • HepB positive for greater than 12 months

  • Taking antiviral medication (NUCs) for more than 12 months

  • Have a HBV DNA less than 90 IU/mL

  • Not cirrhotic

  • No other significant medical conditions e.g. cancer, heart failure.

Potential Benefits:

  • May achieve improved control and clearance of HepB infection

  • Possibility of lasting effect from a one-time only treatment

  • Precise, targeted approach with no risk of cutting DNA

Potential Risks:

  • Epigenetic silencing is an investigational approach that has not yet been approved for the treatment of chronic HepB in humans; since no clinical data are available, its precise effects and side effects are not yet known.

  • Using Lipid Nanoparticles (LNPs) to deliver drugs like Tune-401 has been known to create toxicity and immune/allergic reactions in some individuals.

How to get in touch:

  • Talk to your Hepatitis Foundation nursing team.

  • Visit NZCR here and complete the form. The NZCR team will then be in touch.

  • Email the NZCR team on Rhythm.Auckland@nzcr.co.nz with your contact details.

Visit us here to find out more information

 NZCR clinical trials involve an investigational drug and some study assessments.

 

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