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Infectious Diseases clinical trial

Nucleoside withdrawal in HBe Ag negative hepatitis B virus infection to promote HBsAg clearance (Nuc-B)

Summary:
Hepatitis B virus (HBV) causes infection of the liver, either a severe infection with a shorter duration (acute) or a
persistent longer term infection (chronic). Worldwide there are 350 million people with chronic HBV infection. Two
types of treatment for chronic HBV infection are available: interferons or nucleoside/nucleotide analogues. Interferons
are used for a finite period of time and treatment rarely results in elimination of the virus ie a cure. The majority of
patients therefore choose to be treated instead with nucleos(t)ide analogues – tablets taken every day that cause no
side effects, however, once started the majority of patients will need to continue taking them for the rest of their life.
There is evidence from a recent clinical trial that if treatment with nucleos(t)ide analogues is stopped after a few years
of treatment/viral suppression some patients may be able to eliminate the virus. We therefore want to confirm the
findings from this trial, following patients for at least three years after cessation of treatment and in addition use
interferon in some of the patients at the time that the nucleos(t)ide analogue treatment is withdrawn to increase the
immune response against the virus. Elimination of the virus is important because it represents cure of infection so all
treatment can be safely discontinued.
We anticipate three outcomes for the trial patients. 1. Viral elimination (a cure), 2 A sustained virological response
(their immune system can keep the virus at a low level) or 3. They might relapse and restart their nucleos(t)ide
analogues. In future it will be important to be able to predict which patients have which outcome so as part of this trial
we will measure a number of variables by testing patients’ liver and blood samples to predict which patients are most
likely to benefit from which treatment.

Inclusion criteria:
• Age ≥ 18
• Chronic HBV infection
• HBeAg negative
• Nucleos(t)ide analogues treatment for ≥3 years
• HBV DNA < 400 IU/ml ≥2 years • Informed consent Exclusion criteria:
• Cirrhosis at any time
• HBeAg to anti-HBe seroconversion within the last 3 years
• Interferon use in the last 3 years
• Contraindications to interferon use
• Participation in HBV-specific therapeutic vaccine studies within 12 months
• HCV, HDV or HIV co-infection
• Immunosuppressant use
• Clinically significant comorbidities that, in the opinion of the investigator, render the patient unsuitable

Principal Investigator for this trial: Dr Stephen D Ryder

Research Ethics Committee Reference: 16/LO/1318

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076

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