hepatitis B
Conditions
Interventions
treatment cessation.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age 18 * 65 years Treatment with entecavir or tenofovir Previously HBeAg positive patients: stable HBeAg seroconversion (confirmed HBeAg seroconversion at least 6 months apart) with at least 12 months of subsequent consolidation therapy with HBV DNA
Exclusion criteria
Exclusion criteria: * History of liver biopsy with advanced fibrosis or cirrhosis (F3 or F4) * History of hepatic decompensation * (history of) hepatocellular carcinoma * Other active malignancy * (planned) treatment with immunosuppressive agents * (planned) pregnancy * Coinfection with HIV, HCV, HDV * Concomitant liver condition that may influence liver chemistry (such as Gilbert*s syndrome). Defined as baseline ALT > 2x upper limit of normal, and/or bilirubin > 1x upper limit of normal. * Other indication for continued nucleo(s)tide analogue therapy * Expected noncompliance to follow-up * Treatment with medication that increases INR (such as vitamin K antagonists) * 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 (HBV DNA | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Long-term sustained response, defined as HBV DNA 1.5 x the upper limit of normal and/or INR > 1.5) 5. Relationship between sustained response at week 48 and 96 and serum levels of HBsAg at the time of treatment cessation 6. ALT levels at week 48 and 96 7. Fibroscan value at week 96 | — |
Countries
Netherlands
Outcome results
None listed