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The aim of this study is to compare the BW and metabolic profiles of CHB patient before and after shifting to TAF therapy.
In this study, investigators will enroll 100 entecavir and 100 TDF treated CHB patients who will switch to TAF and then follow for one year. Demographic, liver function tests, sugar profiles, lipid profiles, ASCVD risk score, body weight, body weight, body height, and waist circumference will be checked and recorded periodically.
Investigators anticipated that body weight will change significantly after switching to TAF in both entecavir and TDF group and may associated with increased risk of cardiovascular risk.
Currently, three oral nucleoside/tides analogues (NUC), including entecavir(ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF), are available as the first line of treatment option for chronic hepatitis B (CHB) in Taiwan. Among them, TDF exhibits a greater decline of cholesterol, High-density lipoprotein(HDL), and low-density lipoprotein (LDL) levels than entecavir, while the impact of such general lipid-lowering effects on the risk of atherosclerotic cardiovascular diseases (ASCVD) remains unclear. For metabolic features, the evidence comes from HIV patients treated with TDF or TAF containing anti-retroviral therapy (ART). In one study revealed that a 0.45 kg/m2 increase of body mass index (BMI) and a 13% of increase in ASCVD risk score after switching from TDF-containing to TAF-containing ART. Weight gain after starting ART has been reported to associate with lower mortality in initial under-weight or normal-weight HIV patients. However, a study compared the efficacy and safety of dolutegravir/TAF/emtricitabine, dolutegravir/TDF/emtricitabine, and EFV/TDF/emtricitabine and revealed that patients receiving TAF and TDF containing regimens significantly increased body weight. The subsequent body composition analysis showed weight gain mainly resulted from increased lean muscle and fat of trunk and limb. A previous study also showed that the ART-associated increase in muscle area, regardless of regimen, is likely a reflection of increased fat within the muscle that may associate with weakness of muscle strength, risk of fall, and a decline of physical activities.
Overall, in HIV-infected patients, TAF-containing regimens had been shown to increase body weight resulting from increased fat and muscle of trunk and limb. However, it remains unknown whether all these findings in HIV infected patients could be similarly observed in CHB patient receiving TAF therapy, which is commonly encountered in Asia-Pacific region. Moreover, the mechanisms underlying these changes are still unclear. The long-term clinical impact of the BW gain and associated metabolic derangement is also unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir Disoproxil Fumarate(TDF) switch to TAF | The indications of TDF switching to TAF due to adverse events of TDF or physician's judgement according to clinical conditions. | ||
| Entecavir(ETV)switch to Tenofovir Alafenamide(TAF) | In entecavir switch group, at least 30 patients should have baseline BW data before entecavir treatment. The indications of entecavir switching to TAF include suboptimal HBV suppression (defined as detectable HBV DNA after at least one year of entecavir treatment), adverse events due to entecavir, physician's judgement according to clinical conditions. | ||
| observation groups with take either entecavir (25patients) or TDF (25 patients). | observation groups with total 50 patients who continuously take either entecavir (25patients) or TDF (25 patients) will be enrolled.Examination schedules for these two additional groups are the same as switching groups. |
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| Measure | Description | Time Frame |
|---|---|---|
| 1.Body weight changes after shifting to TAF treatment. | Collection Body weight data before and after treatment. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 2.Changes of lipid and sugar profiles before and after shifting to TAF treatment. | Collection lipid( include TG<mg/dl>/Chol<mg/dl>,/LDL<mg/dl>/ HDL<mg/dl>) data and sugar profiles(include Insulin<uU/ml>, fasting sugar<mg/dl>, glycosylated hemoglobin<%>) data before and after treatment. | 48 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic hepatitis B patients who have been treated with TDF (n=100) or entecavir (n=100) will switch to TAF.
In entecavir switch group, at least 30 patients should have baseline BW data before entecavir treatment. The indications of entecavir switching to TAF include suboptimal HBV suppression (defined as detectable HBV DNA after at least one year of entecavir treatment), adverse events due to entecavir, patient's decision, and physician's judgement according to clinical conditions.
The scheduled treatment duration from enrolment should be greater than one year. Treatment indications for HBeAg-positive chronic hepatitis B, HBeAg-negative chronic hepatitis B and liver cirrhosis are based on reimbursement criteria of Taiwan government.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pin-Nan Cheng, PhD | Contact | +886-972401223 | pncheng@mail.ncku.edu.tw | |
| Li-Chen Lin | Contact | +886-910819731 | lichenlin516@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pin-Nan Cheng, PhD | National Cheng-Kung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng-Kung University Hospital | Recruiting | Tainan | 704 | Taiwan |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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We collection plasma.
| 3.Virologic responses following TAF treatment. |
Collection Virologic data (e.g HBV DNA<IU/ml>,)before and after treatment. |
| 48 weeks. |
| 4.Renal function after shifting to TAF treatment. | Collection Renal function(include Cr<mg/dL>/eGFR<ml/min/1.73m2>)data before and after treatment. | 48 weeks. |
| 5. ASCVD score changes before and after shifting to TAF treatment. | Collection ASCVD score before and after treatment. | 48 weeks. |