Chronic hepatitis B virus
Conditions
Interventions
Case series:Tenofovir alafenamide(TAF)
Sponsors
The 2nd People’s Hospital of Yunnan Wei Jia
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Males and females aged >=18 years; 2. HBeAg-negative and HBe-positive patients with chronic HBV infection of treatment experienced who were treated with any oral antiviral agent for at least 1 year and were in virologically suppressed (at least 70% patients using ADV/TDF will be switched to TAF and Cap ETV patients at 30% will be switched to TAF); 3. One minute test assessment tool for screening early HBV patients to be at risk of osteoporosis, and diagnose further osteopenia or osteoporosis by central DEXA reading. (PI will assign a radiologist as a centralized DEXA scan reader, and all measurements of bone mineral density were corrected for site variations).
Exclusion criteria
Exclusion criteria: 1. Patients who had already undergone drug intervention due to osteoporosis at screening will be excluded from the study; subjects who require drug intervention for osteoporosis (other than calcium and/or vitamin D) during the study period will be included but evaluated using a sensitivity analyses; 2. Decompensated cirrhosis; 3. HBV with hepatocellular carcinoma; 4. Co-infected :with hepatitis C,hepatitis D, or HIV; 5. e-GFR <15ml/min/1.73m2 without hemodialysis; 6. pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMD(g/cm2); | — |
Secondary
| Measure | Time frame |
|---|---|
| HBV-DNA(IU/mL);ng/ml;ALT;PINP; | — |
Countries
China
Contacts
Public ContactJia Wei
The 2nd People’s Hospital of Yunnan
Outcome results
None listed