TAF Real World Study for Universal Effectiveness

Study Overview
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Brief Summary
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This study is a multi-center, prospective, real-world study, males and non-pregnant, non-lactating female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.

Detailed Description
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This study is a multi-center, prospective, real-world study, aiming to investigate the use of TAF in routine clinical management of chronic hepatitis B patients and evaluate its effectiveness and safety across a heterogeneous population in China. Approximately 500 patients will take part in this study, 10 sites will be included which distribute in China's major cities, thus each site will enroll 50 patients. Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.

Official Title
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A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China

Conditions
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Chronic Hepatitis b

Intervention / Treatment
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* Drug: Tenofovir Alafenamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have the ability to understand and sign a written informed consent form, consent must be obtained prior to initiation of study procedures Adult males and nonpregnant, nonlactating females Documented evidence of chronic HBV infection previously TAF naive Exclusion Criteria: Patents who were TAF experienced Women who are breastfeeding Pregnant females Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an imaging study is required) Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, fatty liver disease, cholangitis) Current evidence of Child-Pugh Score C decompensated liver disease,or moderate to severe ascites, Grade III-IV hepatic encephalopathy Abnormal hematological and biochemical parameters, including: Albumin < 2.8 mg/ dL International normalized ratio (INR) > 2.3 X ULN (unless stable on anticoagulant regimen) Total bilirubin > 3 X ULN Patient develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity Received solid organ or bone marrow transplant, except patients who underwent liver or kidney transplantation Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible. Individuals receiving ongoing therapy with drugs not to be used with TAF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements Use of investigational agents within 3 months of screening, unless allowed by the sponsor Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance Inability or unwillingness to provide informed consent or abide by the requirements of the study In addition to the above exclusion criteria, patients who meet any of the contraindications for TAF

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tenofovir alafenamide (TAF)<br>Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with anti-HBV agents. | Drug: Tenofovir Alafenamide<br>* The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents<br>* Other names: Vemlidy®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of participants with HBV DNA < 20 IU/mL | proportion of participants with HBV DNA < 20 IU/mL as measured by the COBAS TaqMan HBV Test (Roche Molecular Diagnostics, Pleasanton, CA, USA), with taken at 36 months | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with HBV DNA < 20 IU/mL | The proportion of patients with HBV DNA < 20 IU/mL at 12 months | 12 months | 
| The proportion of patients with HBV DNA <300 copies/mL | The proportion of patients with HBV DNA <300 copies/mL at 12 months | 12 months | 
| The proportion of patients with HBV DNA < 20 IU/mL | The proportion of patients with HBV DNA < 20 IU/mL at 24 months | 24 months | 
| The proportion of patients with HBV DNA <300 copies/mL IU/mL | The proportion of patients with HBV DNA <300 copies/mL at 24 months | 24 months | 
| The proportion of patients with HBV DNA <300 copies/mL IU/mL | The proportion of patients with HBV DNA <300 copies/mL at 36 months | 36 months | 
| Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss | Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss at 36 months | 36 months | 
| Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) | Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) at 36 months | 36 months | 
| Proportion of participants with Normal Alanine Aminotransferase (ALT) | Proportion of participants with Normal Alanine Aminotransferase (ALT) at 36 months | 36 months | 
| Change from baseline in fibrosis as assessed by Fibroscan® | Change from baseline in fibrosis as assessed by Fibroscan® at 36 months | 36 months | 
| Percent Change from baseline in Bone Mineral Density (BMD) | Percent Change from baseline in Bone Mineral Density (BMD) at 36 months | 36 months | 
| Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) | Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at 36 months | 36 months | 
| the rate of mother-to-child transmission of HBV | For unplanned pregnant subjects, if not withdrawn, mother-to-child transmission (MTCT) rate | at postpartum 6 months |