Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-12-31

Brief Summary

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Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials.

The primary objective of this study is to compare the risk of chronic kidney disease (CKD) progression in chronic hepatitis B patients on TAF versus ETV in a territory-wide cohort in Hong Kong.

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Detailed Description

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Antiviral therapy with nucleos(t)ide analogues (NAs) has revolutionized the management of chronic hepatitis B (CHB) in the last two decades.1 Entecavir (ETV), a nucleoside analogue, is one of the first-line NAs recommended by all international treatment guidelines.2-4 As hepatitis B surface antigen (HBsAg) seroclearance rarely occurs, most patients require long-term, if not life-long, NA therapy. Hence, the safety of NAs requires careful scrutiny. In clinical trials, nephrotoxicity may occur in a small proportion of patients receiving nucleotide analogues. We previously demonstrated that tenofovir disoproxil fumarate (TDF) was associated with mild renal impairment in a minority of patients; those treated with entecavir (ETV) had a similar risk compared to untreated patients.5

Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials.

Conditions

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Chronic Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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TAF-treated Chronic hepatitis B patients

Chronic hepatitis B patients that treated with Tenofovir alafenamide

Tenofovir alafenamide

Intervention Type DRUG

Chronic hepatitis B patients who are receiving TAF as antiviral therapy for CHB, who were previously treatment naïve.

ETV-treated Chronic hepatitis B patients

Chronic hepatitis B patients that treated with Entecavir

Entecavir

Intervention Type DRUG

Chronic hepatitis B patients who are receiving ETV as antiviral therapy for CHB, who were previously treatment naïve.

Interventions

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Tenofovir alafenamide

Chronic hepatitis B patients who are receiving TAF as antiviral therapy for CHB, who were previously treatment naïve.

Intervention Type DRUG

Entecavir

Chronic hepatitis B patients who are receiving ETV as antiviral therapy for CHB, who were previously treatment naïve.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Positive hepatitis B surface antigen (HBsAg) or documented history of CHB for 6 months or more; AND
* On TAF 25 mg daily as antiviral treatment for CHB (cases); OR
* On ETV 0.5 to 1.0 mg daily as antiviral treatment for CHB (controls)

Exclusion Criteria

* Previous NA treatment prior to TAF or ETV
* Positive antibody against hepatitis C, D, or human immunodeficiency virus (anti-HCV, anti-HDV, or anti-HIV)
* Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease).
* Moribund state including advanced/pre-terminal liver cancer or other non-hepatic cancers
* Non-hepatic cancer undergoing chemotherapy within last 6 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No