chronic hepatitis B
Conditions
Interventions
cessation of treatment
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: „X Age 18 ¡V 65 years „X Treatment with entecavir or tenofovir „X Previously HBeAg-positive patients: stable HBeAg seroconversion (confirmed HBeAg seroconversion at least 6 months apart) with at least 12 months of subsequent consolidation therapy „X HBeAg negative patients: at least 3 years of viral suppression (HBV DNA <80 IU/mL).
Exclusion criteria
Exclusion criteria: „X Presence of advanced liver disease defined as advanced fibrosis or cirrhosis (METAVIR F3 or F4; based on imaging, biopsy or liver stiffness assessment) „X History of hepatic decompensation „X (history of) hepatocellular carcinoma „X Other active malignancy „X (planned) treatment with immunosuppressive agents „X (planned) pregnancy „X Coinfection with HIV, HCV, HDV „X Other indication for continued nucleo(s)tide analogue therapy „X Expected noncompliance to follow-up „X Unwillingness to refrain from sexual activity without condom with partners who are not vaccinated against hepatitis B virus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained response, defined as HBV DNA < 2,000 IU/mL at week 48 after therapy discontinuation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Need for retreatment (according to study protocol or treating physician) 2. HBsAg clearance at week 48. Occurrence of signs of liver failure (defined as bilirubin > 1.5 x the upper limit of normal and/or INR > 1.5) 4. Relationship between sustained response at week 48 and serum levels of HBsAg at the time of treatment cessation | — |
Contacts
Public ContactMilan Sonneveld
Outcome results
None listed