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The investigators will conduct a multicenter observational study to evaluate the safety and efficacy of TAF 25 mg QD in chronic hepatitis B patients with antiviral resistance who switch from TDF to TAF. The safety and antiviral activity will be assessed as a part of routine medical care. Subjects will be obtained from an existing cohort of patients treated with a TDF-based regimen due to antiviral resistance, which has been supported by Gilead (IN-US-174-1255).
It is anticipated that approximately 300 CHB patients with antiviral resistance taking TDF 300 mg QD will be enrolled in this study. All consecutive patients will be allocated to receive either TAF 25 mg QD or TDF 300 mg QD (possibly 50% vs. 50%, the proportion of patients enrolled in the study is an estimate based on the clinical experience.), according to the decision of the individual patients and their physicians, with informed consent. Patients are switched independently based on physicians discretion/decision prior to study enrollment, and the study protocol would NOT have any influence over the process.
All consecutive patients will be prospectively monitored every 6 months during the first year and thereafter every 6 months up to 3 years. At each visit, a routine examination and determination of biochemical and virological parameters (HBV DNA level, HBeAg, anti-HBe, HBsAg [quantitatively, if available], and anti-HBs) will be performed. Lab tests and markers will be routinely monitored every 6 months.
Recruitment method: In this study, we plan to use an existing cohort of patients treated with a TDF-based regimen due to antiviral resistance (IN-US-174-1255). Data on all consecutive patients currently receiving TDF due to antiviral resistance at enrollment will be followed up prospectively every 3-6 months for 2 years. The patients will be recruited consecutively. Patients will be recruited only after the treatment decision has been made. No aspect of this study will interfere with or influence routine medical practice.
Number of study sites: At least seven representative institutes in South Korea. Target population: Korean adult subjects with CHB receiving TDF due to antiviral resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir Disoproxil Fumarate 300 mg QD | Administered Tenofovir Disoproxil Fumarate 300 mg QD |
| |
| Tenofovir Alafenamide | Administered Tenofovir Alafenamide 25 mg QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir disoproxil fumarate 300mg | Drug | Administered Tenofovir disoproxil fumarate 300 mg QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum HBV DNA level | The proportion of subjects who achieve a sustained serum HBV DNA level < 20 IU/mL (undetectable serum HBV DNA by PCR) | at week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum HBV DNA level | The proportion of subjects who achieve a sustained serum HBV DNA level < 20 IU/mL (undetectable serum HBV DNA by PCR) | at week 96 |
| Hip and spine BMD | The percent change in hip and spine BMD from baseline |
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Inclusion Criteria:
Exclusion Criteria:
• Co-infection with HCV, HDV, HIV
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The investigators will conduct a multicenter observational study to evaluate the safety and efficacy of TAF 25 mg QD in chronic hepatitis B patients with antiviral resistance who switch from TDF to TAF. Subjects will be obtained from an existing cohort of patients treated with a TDF-based regimen due to antiviral resistance, which has been supported by Gilead (IN-US-174-1255).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mi Young Jeon | Contact | +82-10-8028-2456 | hyuk4385@yuhs.ac | |
| Jun Young Park | Contact | +82-10-8353-0670 | DRPJY@yuhs.ac |
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| Tenofovir Alafenamide 25 mg | Drug | Administered Tenofovir Alafenamide 25 mg QD |
|
|
| at 48, 96 week |
| Serum eGFR | The change in serum eGFR (Cockcroft-Gault method) from baseline | at 24, 48, 72, and 96 week |
| Serum creatinine & PO4 level | The change in serum creatinine & PO4 from baseline | at 24, 48, 72, and 96 week |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| C442442 | tenofovir alafenamide |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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