Not Yet RecruitingPhase 2ACTRN12615000915550

A study of peginterferon-alfa intervention to achieve hepatitis B surface antigen loss in chronic hepatitis B participants under long-term viral suppression with nucleoside analogues

Peg-interferon-alfa to achieve HBsAg loss in chronic hepatitis B under long-term viral suppression with nucleoside analogues

Sponsor

Peter Angus

Enrollment

50 participants

Start Date

Sep 7, 2015

Study Type

Interventional

Conditions

Chronic Hepatitis B

Summary

This is a study to see if add-on peginterferon-alfa (pegIFNa) can help lose hepatitis B surface antigen in patients who have chronic hepatitis B and treated with longterm nucleotide analogue therapy. We hypothesize that in participants under long term viral suppression with potent oral therapy nucleoside analogues, addon pegIFNa will reduce serum HBsAg levels and lead to HBsAg loss. We propose an investigator initiated proof of concept study to evaluate the efficacy of add-on pegIFNa therapy in patients who have been treated with tenofovir or entecavir for at least 18 months Those suitable will be treated with a minimum 24 weeks of pegIFNa. Depending on their response, pegIFNa therapy may be extended for up to 48 weeks or ceased.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria7

Informed consent
Age > 18 years
HBsAg-positive
HBeAg negative
On entecavir or tenofovir > 18 months
HBV DNA level undetectable for > 18 months
HBsAg < 1000 IU/mL

Exclusion Criteria1

Severe liver disease which excludes them from peg-interferon

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The intervention is: Addition of peginterferon-alpha (pegIFNa) to existing nucleos(t)ide analogues (NA) therapy in patients who are on long-term NA therapy and have achieved viral suppression but not

The intervention is: Addition of peginterferon-alpha (pegIFNa) to existing nucleos(t)ide analogues (NA) therapy in patients who are on long-term NA therapy and have achieved viral suppression but not clearance. The dose of pegIFNa is 180mcg subcutaneously weekly. The patients recruited into the trial will already be on an antiviral , either entecavir or tenofovir. The usual doses of enetcavir and tenofovir in standard of care are 0.5-1 mg daily (oral tablet) for entercavir and 300 mg daily (oral tablet) for tenofovir. At the time of entry into the trial, patients are on either entecavir or tenofovir, not both oral agents at the same time. Duration of pegIFNa: 24 weeks or 48 weeks depending on stopping rules Stopping rules : There will be stopping rules at week 24. These are: * HBV DNA detectable at week 24 * HBsAg > 1000 IU/mL at week 24 * HBsAg decline <0.1 Log IU/mL at week 24 The doses of entecavir or tenofovir will be the doses provided as part of standard of care which are the existing dose that the participants are already on. Patients will be on only one oral agent- either tenofovir or entecavir. There will be no changes to NA doses from what the participant is already taking at the time of entry into the trial. The dose of entecavir is 0.5 mg- 1 mg . this is determined by the treating clinician depending on renal function (patients with renal impairment are on a smaller dose). the dose of entecavir will not be changed for the purposes of the trial. If the pegIFNa intervention is futile (based on HBV viral load and HBsAg titres), treatment will be ceased. Patients who have responded will receive consolidation pegIFNa for up to 48 weeks Mode of administration: subcutaneous injection of interferon, oral tablets for NA strategies used to monitor adherence to the intervention: counting drug tablets , history taking from the patient