Patient SatisfactionNCT05583006
Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B
An observational study of Patient Satisfaction and Drug Adherence, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patient Satisfaction, Drug Adherence, Efficacy, Self
- What is being tested?
- tenofovir alafenamide (TAF)
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Nov 2023to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Teng-Yu Lee, MD, PhD, +886423592525 ext. 3301, tylee@vghtc.gov.tw
About this study
Official title: A Prospective Cohort Study of Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B Patients Who Are Unsatisfied to Entecavir Therapy
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.
Read the detailed description
Although nucleos(t)ide analogue (NA) therapy can effectively suppress HBV replication, the ideal therapeutic endpoints, including hepatitis B surface antigen(HBsAg) seroclearance, is difficult to achieve.(1) Therefore, chronic hepatitis B (CHB) patients often require long-term HBV suppression to achieve the therapeutic goals, with the adherence to long-term NA therapy being an important clinical issue.(2, 3) ETV is one of the standard treatments for CHB,(4, 5) but its absorption can be significantly reduced by food.(6) ETV users must take the pills two hours before or after meals, and the blood level of ETV may thus be affected if this recommendation is not fully followed.In addition, the metabolism of ETV is involved by renal excretion, therefore the dosage of ETV should be adjusted according to renal function.(7) For example, among patients in chronic kidney disease (CKD) stage 4, i.e.,eGRF15-29 ml/min/1.73m, the frequency of ETV taking should be reduced from once daily to every 72-96 hours, which may be forgettable and inconvenient to ETV users.However, the adherence of NA therapy is an essential part for long-term HBV suppression, and the efficacy of ETV therapy may be affected by the reduced adherence during long-term therapy.
Except ETV, TAF is also a HBV antiviral recommended by the current practice guidelines in the treatment of CHB, with a high potency in antiviral efficacy and low rate in virological resistance.(4, 5) In addition, TAF can be a 2nd-line rescue antiviral recommendation for HBV with resistance to ETV therapy.(4, 5) Moreover, because TAF is formulated to deliver the active metabolite to target cells more efficiently than tenofovir disoproxil fumarate (TDF) at a much lower dose, thereby reducing systemic exposure to tenofovir. In the randomized controlled trials,(8, 9) patients in the TAF arm had improved renal function and bone marrow density (BMD),as compared to patients in the TDF arm. Furthermore, in some retrospective studies, switching from ETV to TAF may present a superior efficacy in HBV DNA suppression and HBsAg level reduction,(10-13) and renal safety was comparable between the TAF switch group and the ETV continuation group.(10, 11) Interestingly, switching from ETV to TAF is associated with improvement of the medication adherence,(6) which may be particularly important to patients under long-term NA therapy.
In a small retrospective study conducted in Japan,(14) medication adherence and satisfaction were compared between before and after switch antiviral therapy in patients who switched to TAF from ETV (n = 15), and medication adherence was found to be significantly improved (P = 0.04). In a prospective study aimed to evaluate the changes of serum HBsAg levels during a 48-week period after switching ETV to TAF,(6) the degree of HBsAg reduction was higher during the TAF administration period than during the ETV administration period in patients without cirrhosis, with genotype B HBV, or with undetectable serum hepatitis B core-related antigen (HBcrAg).The HBV cccDNA-related biomarkers, such as quantitative HBsAg (qHBsAg) or HBcrAg, have been considered important outcome predictors.(15, 16) With expected adherence improvement in TAF switch therapy, the changes of above-mentioned biomarkers may be improved. 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
- Being tested
- tenofovir alafenamide (TAF)
- Medical subject headings
- Patient Satisfaction, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir alafenamide (TAF)Drug
Also called Vemlidy
TAF switch therapy in CHB patients who are unsatisfied to ETV therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate/ concentration of renal function markers
The changes of eGFR, urine protein, urine beta 2-microglubulin, etc.
Measured: week 48
HBV viral load
Measured: week 48
The satisfaction (including drug adherence) to TAF switch therapy
The changes of TSQM-9 questionnaire, MMAS-8 questionnaire
Measured: week 48
Secondary outcomes (4)
Rate/ concentration of renal function markers
The changes of eGFR, urine protein, urine beta 2-microglubulin, etc.
Measured: week 144
HBV viral load
Measured: week 144
The satisfaction (including drug adherence) to TAF switch therapy
The changes of TSQM-9 questionnaire, MMAS-8 questionnaire
Measured: week 144
Concentration of biochemical markers
bilirubin, AST, ALT
Measured: week 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start6 Nov 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Adherence to Medication
- Responsible party
- Sponsor
- Investigators
- Teng-Yu Lee, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583006
- Sponsor's protocol ID
- CE22348B
- Status last verified
- Jan 2025
- First submitted
- 14 Oct 2022
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28778687Sheppard-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.
PubMed 29355830Lee 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.
PubMed 29980192Terrault 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.
PubMed 29405329European 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.
PubMed 28427875Uchida 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.
PubMed 31777965Yan 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.
PubMed 17050790Chan 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.
PubMed 28404091Buti 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.
PubMed 28404092Li 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.
PubMed 33404182Hagiwara 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.
PubMed 31199513Kumada 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.
PubMed 32282538Ogawa 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.
PubMed 32304611Tamaki 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.
PubMed 31994737Tseng 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.
PubMed 31470004
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B Patients Who Are Unsatisfied to Entecavir Therapy
- ClinicalTrials.gov ID
- NCT05583006
- Acronym / sponsor ID
- CE22348B
- Conditions
- Patient Satisfaction, Drug Adherence, Efficacy, Self, Safety Issues
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Institute of Adherence to Medication
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although nucleos(t)ide analogue (NA) therapy can effectively suppress HBV replication, the ideal therapeutic endpoints, including hepatitis B surface antigen(HBsAg) seroclearance, is difficult to achieve.(1) Therefore, chronic hepatitis B (CHB) patients often require long-term HBV suppression to achieve the therapeutic goals, with the adherence to long-term NA therapy being an important clinical issue.(2, 3) ETV is one of the standard treatments for CHB,(4, 5) but its absorption can be significantly reduced by food.(6) ETV users must take the pills two hours before or after meals, and the blood level of ETV may thus be affected if this recommendation is not fully followed.In addition, the metabolism of ETV is involved by renal excretion, therefore the dosage of ETV should be adjusted according to renal function.(7) For example, among patients in chronic kidney disease (CKD) stage 4, i.e.,eGRF15-29 ml/min/1.73m, the frequency of ETV taking should be reduced from once daily to every 72-96 hours, which may be forgettable and inconvenient to ETV users.However, the adherence of NA therapy is an essential part for long-term HBV suppression, and the efficacy of ETV therapy may be affected by the reduced adherence during long-term therapy.
Except ETV, TAF is also a HBV antiviral recommended by the current practice guidelines in the treatment of CHB, with a high potency in antiviral efficacy and low rate in virological resistance.(4, 5) In addition, TAF can be a 2nd-line rescue antiviral recommendation for HBV with resistance to ETV therapy.(4, 5) Moreover, because TAF is formulated to deliver the active metabolite to target cells more efficiently than tenofovir disoproxil fumarate (TDF) at a much lower dose, thereby reducing systemic exposure to tenofovir. In the randomized controlled trials,(8, 9) patients in the TAF arm had improved renal function and bone marrow density (BMD),as compared to patients in the TDF arm. Furthermore, in some retrospective studies, switching from ETV to TAF may present a superior efficacy in HBV DNA suppression and HBsAg level reduction,(10-13) and renal safety was comparable between the TAF switch group and the ETV continuation group.(10, 11) Interestingly, switching from ETV to TAF is associated with improvement of the medication adherence,(6) which may be particularly important to patients under long-term NA therapy.
In a small retrospective study conducted in Japan,(14) medication adherence and satisfaction were compared between before and after switch antiviral therapy in patients who switched to TAF from ETV (n = 15), and medication adherence was found to be significantly improved (P = 0.04). In a prospective study aimed to evaluate the changes of serum HBsAg levels during a 48-week period after switching ETV to TAF,(6) the degree of HBsAg reduction was higher during the TAF administration period than during the ETV administration period in patients without cirrhosis, with genotype B HBV, or with undetectable serum hepatitis B core-related antigen (HBcrAg).The HBV cccDNA-related biomarkers, such as quantitative HBsAg (qHBsAg) or HBcrAg, have been considered important outcome predictors.(15, 16) With expected adherence improvement in TAF switch therapy, the changes of above-mentioned biomarkers may be improved. The investigators therefore aim to conduct a prospective cohort study of TAF switch therapy for CHB patients who are unsatisfied to ETV therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tenofovir alafenamide (TAF)Also: VemlidyTAF switch therapy in CHB patients who are unsatisfied to ETV therapy. | Drug | – |
Primary outcome
Rate/ concentration of renal function markers
Time frame: week 48
The changes of eGFR, urine protein, urine beta 2-microglubulin, etc.
HBV viral load
Time frame: week 48
The satisfaction (including drug adherence) to TAF switch therapy
Time frame: week 48
The changes of TSQM-9 questionnaire, MMAS-8 questionnaire
4 secondary outcomes
Rate/ concentration of renal function markers
Time frame: week 144
HBV viral load
Time frame: week 144
The satisfaction (including drug adherence) to TAF switch therapy
Time frame: week 144
Concentration of biochemical markers
Time frame: week 144
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Results publication: PubMed 28778687Lok 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.
- Results publication: PubMed 29355830Sheppard-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.
- Results publication: PubMed 29980192Lee 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.
- Results publication: PubMed 29405329Terrault 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.
- Results publication: PubMed 28427875European 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.
- Results publication: PubMed 31777965Uchida 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.
- Results publication: PubMed 17050790Yan 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.
- Results publication: PubMed 28404091Chan 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.
- Results publication: PubMed 28404092Buti 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.
- Results publication: PubMed 33404182Li 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.
- Results publication: PubMed 31199513Hagiwara 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.
- Results publication: PubMed 32282538Kumada 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teng-Yu Lee, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction and Drug Adherence, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teng-Yu Lee, MD, PhD (+886423592525 ext. 3301, tylee@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate/ concentration of renal function markers (time frame: week 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05583006, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.