Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B

NCT05583006 | Recruiting

• 1 other identifier: CE22348B
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic hepatitis B (CHB) patients may be unsatisfied to entecavir (ETV) therapy due to the inconvenience in drug taking, i.e., fasting for more than 2 hours and/or dose adjustment according to estimated glomerular filtration rate (eGFR). However, tenofovir alafenamide (TAF) has been approved to be highly effective and safe in patients with CHB, and is convenient in drug taking, i.e., once daily regardless food taking and renal function.Therefore,TAF can be a good option in CHB patients who are unsatisfied to ETV therapy. The aim of this prospective cohort study is to assess the improvement on satisfaction (including drug adherence) of TAF switch therapy in CHB patients who are unsatisfied to ETV therapy. In addition, with expected adherence improvement in TAF switch therapy, the efficacy of TAF switch therapy may be improved, and the efficacy benefits can be evaluated by the changes of some novel biomarkers, such as HBV core-related antigen (HBcrAg). The investigators therefore aim to conduct a prospective cohort study of TAF switch therapy for CHB patients who are unsatisfied to ETV therapy.

Conditions

Patient Satisfaction; Drug Adherence; Efficacy, Self; Safety Issues

Outcome Measures

Primary Outcomes (3)

• Rate/ concentration of renal function markers

  The changes of eGFR, urine protein, urine beta 2-microglubulin, etc.

  week 48

• HBV viral load

  week 48

• The satisfaction (including drug adherence) to TAF switch therapy

  The changes of TSQM-9 questionnaire, MMAS-8 questionnaire

  week 48

Secondary Outcomes (4)

• Rate/ concentration of renal function markers

  week 144

• HBV viral load

  week 144

• The satisfaction (including drug adherence) to TAF switch therapy

  week 144

• Concentration of biochemical markers

  week 144

Interventions

tenofovir alafenamide (TAF) DRUG

TAF switch therapy in CHB patients who are unsatisfied to ETV therapy.

Also known as: Vemlidy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective cohort study will enroll CHB patients who are unsatisfied to ETV therapy. The patient selection in this study is essentially based on a principle of shared decision making, and not only the physician decides whether to change the treatment. In the initial screening period, study subjects will be selected according to the inclusion and exclusion criteria, therefore only patients who complain the efficacy and/or inconvenience of ETV therapy (Inclusion criteria 4), will be invited to join this study. After discussing with the physician together, the study subjects must sign the inform consents before going into the next step (baseline condition evaluation).

You may qualify if:

• At least 20 years of age
• Detectable serum HBsAg
• Chronic HBV infection under ETV therapy
• ETV users who are unsatisfied with the efficacy and/or feel inconvenient of ETV therapy
• No contraindications for TAF switch therapy
• HBV antiviral period expectancy for at least 1 year

You may not qualify if:

• End stage renal disease (estimated glomerular filtration rate \[eGRF\]\< 15 mL/min/1.73m2) without dialysis
• Co-infected with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
• Any active malignancies
• Under immunosuppressants
• Known allergy to tenofovir-contained regimens

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Institute of Adherence to Medication: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

RECRUITING

Related Publications (17)

• Lok AS, Zoulim F, Dusheiko G, Ghany MG. Hepatitis B cure: From discovery to regulatory approval. J Hepatol. 2017 Oct;67(4):847-861. doi: 10.1016/j.jhep.2017.05.008. Epub 2017 Aug 1.

  PMID: 28778687 BACKGROUND

• Sheppard-Law S, Zablotska-Manos I, Kermeen M, Holdaway S, Lee A, George J, Zekry A, Maher L. Factors associated with non-adherence to HBV antiviral therapy. Antivir Ther. 2018;23(5):425-433. doi: 10.3851/IMP3219.

  PMID: 29355830 BACKGROUND

• Lee SS, Havens JP, Sayles HR, O'Neill JL, Podany AT, Swindells S, Scarsi KK, Bares SH. A pharmacist-led medication switch protocol in an academic HIV clinic: patient knowledge and satisfaction. BMC Infect Dis. 2018 Jul 6;18(1):310. doi: 10.1186/s12879-018-3226-2.

  PMID: 29980192 BACKGROUND

• Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.

  PMID: 29405329 BACKGROUND

• 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 BACKGROUND

• Uchida Y, Nakao M, Tsuji S, Uemura H, Kouyama JI, Naiki K, Motoya D, Sugawara K, Nakayama N, Imai Y, Tomiya T, Mochida S. Significance of switching of the nucleos(t)ide analog used to treat Japanese patients with chronic hepatitis B virus infection from entecavir to tenofovir alafenamide fumarate. J Med Virol. 2020 Mar;92(3):329-338. doi: 10.1002/jmv.25644. Epub 2019 Dec 9.

  PMID: 31777965 BACKGROUND

• Yan JH, Bifano M, Olsen S, Smith RA, Zhang D, Grasela DM, LaCreta F. Entecavir pharmacokinetics, safety, and tolerability after multiple ascending doses in healthy subjects. J Clin Pharmacol. 2006 Nov;46(11):1250-8. doi: 10.1177/0091270006293304.

  PMID: 17050790 BACKGROUND

• Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, Hui AJ, Janssen HL, Chowdhury A, Tsang TY, Mehta R, Gane E, Flaherty JF, Massetto B, Gaggar A, Kitrinos KM, Lin L, Subramanian GM, McHutchison JG, Lim YS, Acharya SK, Agarwal K; GS-US-320-0110 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Epub 2016 Sep 22.

  PMID: 28404091 BACKGROUND

• Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, Hui AJ, Lim YS, Mehta R, Janssen HL, Acharya SK, Flaherty JF, Massetto B, Cathcart AL, Kim K, Gaggar A, Subramanian GM, McHutchison JG, Pan CQ, Brunetto M, Izumi N, Marcellin P; GS-US-320-0108 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):196-206. doi: 10.1016/S2468-1253(16)30107-8. Epub 2016 Sep 22.

  PMID: 28404092 BACKGROUND

• Li ZB, Li L, Niu XX, Chen SH, Fu YM, Wang CY, Liu Y, Shao Q, Chen G, Ji D. Switching from entecavir to tenofovir alafenamide for chronic hepatitis B patients with low-level viraemia. Liver Int. 2021 Jun;41(6):1254-1264. doi: 10.1111/liv.14786. Epub 2021 Jan 19.

  PMID: 33404182 BACKGROUND

• Hagiwara S, Nishida N, Ida H, Ueshima K, Minami Y, Takita M, Komeda Y, Kudo M. Switching from entecavir to tenofovir alafenamide versus maintaining entecavir for chronic hepatitis B. J Med Virol. 2019 Oct;91(10):1804-1810. doi: 10.1002/jmv.25515. Epub 2019 Jul 2.

  PMID: 31199513 BACKGROUND

• Kumada T, Toyoda H, Tada T, Yasuda S, Miyake N, Tanaka J. Comparison of the impact of tenofovir alafenamide and entecavir on declines of hepatitis B surface antigen levels. Eur J Gastroenterol Hepatol. 2021 Feb 1;32(2):255-260. doi: 10.1097/MEG.0000000000001733.

  PMID: 32282538 BACKGROUND

• Ogawa E, Nomura H, Nakamuta M, Furusyo N, Koyanagi T, Dohmen K, Ooho A, Satoh T, Kawano A, Kajiwara E, Takahashi K, Azuma K, Kato M, Shimoda S, Hayashi J; Kyushu University Liver Disease Study (KULDS) Group. Tenofovir alafenamide after switching from entecavir or nucleos(t)ide combination therapy for patients with chronic hepatitis B. Liver Int. 2020 Jul;40(7):1578-1589. doi: 10.1111/liv.14482. Epub 2020 Apr 30.

  PMID: 32304611 BACKGROUND

• Tamaki N, Kurosaki M, Nakanishi H, Itakura J, Inada K, Kirino S, Yamashita K, Osawa L, Sekiguchi S, Hayakawa Y, Wang W, Okada M, Higuchi M, Takaura K, Maeyashiki C, Kaneko S, Yasui Y, Tsuchiya K, Takahashi Y, Izumi N. Comparison of medication adherence and satisfaction between entecavir and tenofovir alafenamide therapy in chronic hepatitis B. J Med Virol. 2020 Aug;92(8):1355-1358. doi: 10.1002/jmv.25692. Epub 2020 Feb 7.

  PMID: 31994737 BACKGROUND

• Tseng TC, Liu CJ, Hsu CY, Hong CM, Su TH, Yang WT, Chen CL, Yang HC, Huang YT, Fang-Tzu Kuo S, Liu CH, Chen PJ, Chen DS, Kao JH. High Level of Hepatitis B Core-Related Antigen Associated With Increased Risk of Hepatocellular Carcinoma in Patients With Chronic HBV Infection of Intermediate Viral Load. Gastroenterology. 2019 Dec;157(6):1518-1529.e3. doi: 10.1053/j.gastro.2019.08.028. Epub 2019 Aug 27.

  PMID: 31470004 BACKGROUND

• Tseng TC, Liu CJ, Yang WT, Hsu CY, Hong CM, Su TH, Tsai CH, Chen CL, Yang HC, Liu CH, Chen HH, Chen PJ, Kao JH. Serum hepatitis B core-related antigen level stratifies risk of disease progression in chronic hepatitis B patients with intermediate viral load. Aliment Pharmacol Ther. 2021 Apr;53(8):908-918. doi: 10.1111/apt.16266. Epub 2021 Jan 19.

  PMID: 33465271 BACKGROUND

• Bharmal M, Payne K, Atkinson MJ, Desrosiers MP, Morisky DE, Gemmen E. Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications. Health Qual Life Outcomes. 2009 Apr 27;7:36. doi: 10.1186/1477-7525-7-36.

  PMID: 19397800 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Medication Adherence

Interventions

tenofovir alafenamide

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Compliance; Patient Acceptance of Health Care

Study Officials

• Teng-Yu Lee, MD, PhD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teng-Yu Lee, MD, PhD

CONTACT

+886423592525; tylee@vghtc.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 17, 2022
• Study Start: November 6, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)