Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Treatment to Ncrease Sustained Response in CHB

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B, sustained response, peginterferon, nucleos(t)ide analogues

Brief summary

Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies investigating whether the effect of lowering viral load with nucleoside analogue therapy prior to the initiation of peginterferon results in higher sustained off-treatment responses showed contradictory findings. The aim of this study is to investigate sustained off-treatment response to peginterferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load

Sylvia M. Brakenhoff, Robert J. de Knegt, Jeffrey Oliveira, Annemiek A. van der Eijk, Anneke J. van Vuuren et al. (10 authors)

The Journal of Infectious Diseases2022-05-2319 citations

10.1093/infdis/jiac210

Low hepatitis B surface antigen and HBV DNA levels predict response to the addition of pegylated interferon to entecavir in hepatitis B e antigen positive chronic hepatitis B

Kin Seng Liem, Margo J. H. van Campenhout, Qing Xie, Willem Pieter Brouwer, Heng Chi et al. (10 authors)

Alimentary Pharmacology & Therapeutics2019-01-2831 citations

10.1111/apt.15098

Pegylated Interferon Alfa-2b Add-on Treatment in Hepatitis B Virus Envelope Antigen-Positive Chronic Hepatitis B Patients Treated with Nucleos(t)ide Analogue: A Randomized, Controlled Trial (PEGON)

Heng Chi, Bettina E. Hansen, Simin Guo, Ning Ping Zhang, Xun Qi et al. (13 authors)

The Journal of Infectious Diseases2017-03-0254 citations

10.1093/infdis/jix024

Interventions

DRUGPegIFN alfa-2b

Peginterferon alpha-2b 1.5 μg/kg per week s.c.for 48 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

No

Inclusion criteria

* Chronic hepatitis B (HBsAg positive \> 6 months) * HBeAg positive, anti-HBe negative within 4 weeks prior to initiation of peginterferon alfa-2b * HBV DNA \< 2000 IU/ml within one month prior to initiation of peginterferon alfa-2b after a minimum of 12 months treatment with either Entecavir (one of all 3 brands) or Tenofovir * ALT \< 5x ULN * Compensated liver disease * Age ≥ 18 years and ≤ 70 years * Written informed consent

Exclusion criteria

* Treatment with any investigational drug within 30 days of entry to this protocol * Treatment with Telbivudine * Severe hepatitis activity as documented by ALT \> 5 x ULN * History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy) * Pre-existent neutropenia (neutrophils \< 1,500/mm3) or thrombocytopenia (platelets \< 90,000/mm3) * Co-infection with hepatitis C virus or human immunodeficiency virus (HIV) * Other acquired or inherited causes of liver disease: alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency * Alpha fetoprotein \> 50 ng/ml * Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Sustained response	at week 72	Sustained response to therapy, defined as the combined presence of HBeAg seroconversion and HBV DNA \< 200 IU/mL

Countries

China, Netherlands

Outcome results

None listed