Chronic Hepatitis B (HBeAg-negative)
Conditions
Brief summary
Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen s (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.
Interventions
DRUGPegylated interferon alfa-2a
Sponsors
Instituto de Salud Carlos III
José Antonio Carrion
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic hepatitis B (HBeAg-negative) * Signed inform consent * Aged \> 18
Exclusion criteria
* Contraindications for Pegylated interferon (cirrhosis, pregnancy, others) * Previous treatment with interferon or Pegylated interferon * Previous HBsAg loss * Treatment duration with Nucleos(t)ide analogues less than 2 years * Poor adherence to Nucleos(t)ide analogues
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with HBsAg loss | 1 year after treatment completion | HBsAg will be evaluated one year after treatment completion (96 weeks). Efficacy will be calculated as a proportion (rate of patients with HBsAg loss/treated patients) |
Outcome results
None listed