ong term efficacy and safety of tenofovir alafenamide fumarate (TAF) in patients with chronic hepatitis B virus(HBV) infections: an observational, non-interventional trial (TOUGH trial)

Recruiting

Conditions: B18.1
Chronic viral hepatitis B without delta-agent

Registration Number: DRKS00017414

Lead Sponsor: niversitätsklinikum Leipzig

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Chronic HBV infection diagnosed at least 6 months prior to inclusion in trial (HBsAg positive > 6 months)
2. Patients receiving newly initiated treatment with TAF or
3. Treatment experienced patients who switch from ongoing antiviral treatment to TAF
3. Age = 18 years
4. Signed informed consent form

Exclusion Criteria

1. Patients who are not willing or able to sign informed consent.
2. Patients with HBV/HIV or HBV/HCV or HBV/HDV coinfection

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Percentage of patients achieving undetectable levels of HBV DNA after 6, 12, 24 and 36 months of treatment with TAF <br>- Percentage of patients achieving HBsAg loss during treatment with TAF<br> - Percentage of patients achieving HBeAg seroconversion treatment with TAF <br>- Percentage of patients developing a decrease in renal function during treatment

Secondary Outcome Measures

Name	Time	Method
- side effects during treatment with TAF<br>- Changes in HBsAg levels during TAF treatment <br>- Percentage of patients with virologic failure defined as:<br> - Confirmed re-increase in HBV DNA levels > 1 log after initial response to TAF <br>- Absence of decrease of HBV DNA > 1 log wihin 12 month of TAF treatment - <br>Partial response: HBV DNA levels > 400 copies/mL after 1, 2 and 3 years of TAF treatment <br>- changes of ALT levels during tough treatment<br>- changes of renal function during treatment<br>- Changes in mineral bone density and lipid panel if diagnostic test are carried out to the disretion of the current physician<br>- changes of liver stiffness during treatment if available<br>- Changes in the HBV polymerase gene in patients with virologic failure to TAF treatment - Change in liver stiffness during TAF treatment<br>