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

NCT05423834 | Active Not Recruiting

• 1 other identifier: TAF-renal study
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• CKD at 12 months

  To evaluate chronic kidney disease (CKD) progression at 12 months. The CKD progression is defined as an increase in CKD stage for at least 1 stage for at least 3 consecutive months during follow-up.

  12 months

Secondary Outcomes (1)

• Change in eGFR

  12 months

Study Arms (2)

TAF-treated Chronic hepatitis B patients

Chronic hepatitis B patients that treated with Tenofovir alafenamide

Drug: Tenofovir alafenamide

ETV-treated Chronic hepatitis B patients

Chronic hepatitis B patients that treated with Entecavir

Drug: Entecavir

Interventions

Tenofovir alafenamide DRUG

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

TAF-treated Chronic hepatitis B patients

Entecavir DRUG

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

ETV-treated Chronic hepatitis B patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CHB patients who are receiving TAF or ETV as antiviral therapy for CHB, who were either previously treatment naïve.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (5)

• Lo AO, Wong GL. Current developments in nucleoside/nucleotide analogues for hepatitis B. Expert Rev Gastroenterol Hepatol. 2014 Aug;8(6):607-22. doi: 10.1586/17474124.2014.909724. Epub 2014 Apr 30.

  PMID: 24787673 RESULT

• European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.

  PMID: 28427875 RESULT

• Sarin SK, Kumar M, Lau GK, Abbas Z, Chan HL, Chen CJ, Chen DS, Chen HL, Chen PJ, Chien RN, Dokmeci AK, Gane E, Hou JL, Jafri W, Jia J, Kim JH, Lai CL, Lee HC, Lim SG, Liu CJ, Locarnini S, Al Mahtab M, Mohamed R, Omata M, Park J, Piratvisuth T, Sharma BC, Sollano J, Wang FS, Wei L, Yuen MF, Zheng SS, Kao JH. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016 Jan;10(1):1-98. doi: 10.1007/s12072-015-9675-4. Epub 2015 Nov 13.

  PMID: 26563120 RESULT

• Terrault NA, Bzowej NH, Chang KM, Hwang JP, Jonas MM, Murad MH; American Association for the Study of Liver Diseases. AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016 Jan;63(1):261-83. doi: 10.1002/hep.28156. Epub 2015 Nov 13. No abstract available.

  PMID: 26566064 RESULT

• Wong GL, Chan HL, Tse YK, Yip TC, Lam KL, Lui GC, Szeto CC, Wong VW. Chronic kidney disease progression in patients with chronic hepatitis B on tenofovir, entecavir, or no treatment. Aliment Pharmacol Ther. 2018 Nov;48(9):984-992. doi: 10.1111/apt.14945. Epub 2018 Aug 20.

  PMID: 30125952 RESULT

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

tenofovir alafenamide; entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 21, 2022
• Study Start: September 1, 2022
• Primary Completion: December 21, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)