Long 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)

Long 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) - TOUGH

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017414

Enrollment

200

Registered

2019-09-25

Start date

2018-10-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B18.1

Interventions

Group 1: Patients receiving treatment with tenofovir alafenamide fumarat (TAF) are monitored for antiviral efficacy and safety for the duration of 3 years. In accordance with international guidelines

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactClaudia Breithaupt

Klinik für Gastroenterologie, Universitätsklinikum Leipzig

claudia.breithaupt@medizin.uni-leipzig.de03419412330

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026