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

The Chinese University of Hong Kong

Status: Active, not recruiting

Conditions: Chronic Hepatitis B

Treatments: Drug: Tenofovir alafenamide; Drug: Entecavir

Study type: Observational

Funder types: Other

Identifiers

NCT05423834

TAF-renal study

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,800 participants in 2 patient groups

TAF-treated Chronic hepatitis B patients

Description:

Chronic hepatitis B patients that treated with Tenofovir alafenamide

Treatment:

Drug: Tenofovir alafenamide

ETV-treated Chronic hepatitis B patients

Description:

Chronic hepatitis B patients that treated with Entecavir

Treatment:

Drug: Entecavir