Effect of Tenofovir Alafenamide on Chronic Hepatitis B with Mild Liver Injury

The Effectiveness and Safety of Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Patients With Mildly Elevated Alanine Aminotransferase and Significant Liver Injury

This study is testing if a medication called Tenofovir Alafenamide can help people with chronic hepatitis B and mild liver injury feel better and improve their liver health.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Cheng-Kung University Hospital (Academic / other)
• Locations: 1 site (Tainan)
• Trial ID: NCT04674423 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of Tenofovir Alafenamide (TAF) in treating patients with chronic hepatitis B (CHB) who have mildly elevated alanine aminotransferase (ALT) levels and significant liver injury. The trial focuses on patients who do not meet the reimbursement criteria for antiviral treatment in Taiwan, specifically those with ALT levels between 1-2 times the upper limit of normal and liver injury assessed by biopsy. By including patients with significant liver injury, the study aims to provide insights into the potential benefits of TAF in a previously underserved population. The study is interventional and is conducted at the National Cheng-Kung University Hospital.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 20 years old with chronic hepatitis B, mildly elevated ALT levels, and significant liver injury.

Not a fit: Patients with other etiologies of chronic hepatitis or those who have previously received antiviral treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide effective antiviral therapy for a significant population of chronic hepatitis B patients who currently lack treatment options.

How similar studies have performed: While there have been successful studies using Tenofovir Alafenamide in chronic hepatitis B, this specific approach targeting patients with mildly elevated ALT and significant liver injury is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Age more than 20 years
* Presence of HBsAg positivity for more than 6 months that indicated chronic HBV infection;
* HBV viral load more than 20000 IU/mL in HBeAg positive or more than 2000 IU/mL in HBeAg Negative CHB patients;
* Presence of liver injury which was defined as histology activity index (HAI) \>3 by Knodell necroinflammantion scoring system or liver fibrosis stage 2 or stage 3 by Metavir scoring system; Liver histology available for evaluation 6 months before starting screening is also acceptable. This criteria is limited to subjects enrolling TAF treatment group.
* ALT level between 1-2 folds of ULN for at least one occasion in recent 1 year before screening;
* Treatment naïve;

Exclusion Criteria:

* Other etiology of chronic hepatitis; Those patients with spontaneous clearance of HCV defined as presence of anti-HCV antibody but undetectable of HCV RNA at least 3 months before enrollment and without history of anti-viral treatment could be included.
* Severe comorbid disorders;
* Uncontrolled diabetes mellitus (HBA1c \> 8.5%);
* Current evidence or suspicious of malignancy;
* Diagnosis of liver cirrhosis;
* eGFR \< or = 30 ml/min/1.73m2.
* Any one of following hematology or biochemical or clinical abnormalities:

Albumin \<3.5g/dL, Total Bilirubin \>2.5mg/dL, prothrombin time prolongation \>4 sec or INR \>1.7, platelet count \<100 x 103 uL, and history or presence of ascites or hepatic encephalopathy.

* Child-bearing age women without the willing to contraceptive control, or lactating or pregnant women.

Where this trial is running

Tainan

• National Cheng-Kung University Hospital — Tainan, Taiwan (Recruiting)

Study contacts

• Study coordinator: Pin-Nan Cheng, MD

Conditions Chronic Hepatitis b; Chronic hepatitis B, tenofovir Alafenamide, ALT, liver injury