study outcome and predictors of sustained response in chronic hepatitis B patients who discontinue entecavir or tenofovir
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
sustained response (HBV DNA <2,000) at week 48 after discontinuation.
Secondary outcome
1. Long-term sustained response, defined as HBV DNA < 2,000 IU/mL at week 96
after therapy discontinuation.
2. Need for retreatment (according to study protocol or treating physician)
3. HBsAg clearance at week 48 and 96
4. Occurrence of signs of liver failure (bilirubin > 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
Background summary
Longterm antiviral treatment for chronic hepatitis B with entacavir or
tenofovir is effective but also associated with mounting costs and potential
side effects. Discontinuation of treatment in patients with long-term viral
suppression appears to be safe and is associated with sustained response in 30
* 50%.
Study objective
study outcome and predictors of sustained response in chronic hepatitis B
patients who discontinue entecavir or tenofovir
Study design
prospective cohort study
Intervention
treatment cessation.
Study burden and risks
the benefits include cessation of treatment without further need for taken a
daily pill and also a reduction in potential long-term therapy associated
risks, and a pronounced reduction in healthcare costs. Potential burdens and
risks include additional follow-up visits and bloodwork during the period after
therapy cessation. There appears to be a risk of severe hepatitis that carries
a very low risk of subsequent liver failure if adequately treated.
's Gravendijkwal 230, room Ha204
Rotterdam 3015CE
NL
's Gravendijkwal 230, room Ha204
Rotterdam 3015CE
NL
Listed location countries
Age
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 <80 IU/mL
HBeAg negative patients: at least 3 years of continuous viral suppression (HBV
DNA <80 IU/mL)
Fibroscan value <7.0 at baseline
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62412.078.17 |