Chronic Hepatitis b
Conditions
Keywords
chronic hepatitis B, tenofovir alafenamide, tenofovir disoproxil fumarate, Safety, Efficacy
Brief summary
Recent TAF has introduced to have more safe profiles than TDF in clinical trials. Especially, TDF has the renal safety issue in high risk group including HIV, decompensated cirrhosis (ascites), uncontrolled DM etc. However, there is no available cohort data for treatment efficacy and safety in TDF-TAF switch therapy in treatment-naïve chronic hepatitis B. The aim of this study is to evaluate safety and efficacy of TAF switch therapy in patients with chronic hepatitis B who have been treated with TDF.
Interventions
DRUGtenofovir alafenamide
To evaluate of efficacy and safety in patients with TDF-TAF switch therapy
Sponsors
The Catholic University of Korea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. 2. Adult male and non-pregnant, non-lactating female subjects, 18 years of age and older, based on the date of the screening visit. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential (unless surgically sterile or greater than 2 years post-menopausal). 3. Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months) 4. Previous TDF naïve treatment (more than 96 weeks) baseline status including chronic hepatitis B with the following: * HBeAg-positive and HBeAb negative at Screening * Screening HBV DNA ≥ 1x 105 copies/mL * Screening serum ALT level ≥2×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR * HBeAg-negative and HBeAb positive at Screening * Screening HBV DNA ≥ 1x 104 copies/mL * Screening serum ALT level ≥2×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR * Cirrhosis at Screening * Screening HBV DNA ≥ 1x 104 copies/mL regardless of HBeAg status * Treatment naïve subjects defined as no history of antiviral therapy or \< 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue, including lamivudine or adefovir, clevudine, telbivudine, entecavir 5. The decision is made by the provider and patient to switch from TDF to TAF prior to discussion of the study of enrollment 6. Following the decision to switch therapy, signed written informed consent after being instructed about the objective and procedure of the clinical study 7. Must be willing and able to comply with all study requirements
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Virological response | at Week 96. | Portion of subjects with plasma HBV DNA levels below 116 copies/mL |
| Incidence of of elevation of serum creatinine as a measure of renal safety | at Week 96 | Incidence of elevation of serum creatinine (\>0.5mg/dL) from baseline creatinine |
| Incidence of osteopenia and osteoporosis as a measure of bone safety | at Week 96 | Incidence of osteopenia and osteoporosis according to Bone Mineral Density |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical response | at Week 48 and 96 | ALT normalization (Male \<30 IU/L, Female \<19 IU/L) |
| Serologic response | at Week 48 and 96 | loss rate of HBeAg in HBeAg positive patients |
| Incidence of treatment-emergent adverse events | at Week 48 and 96 | all adverse events during tenofovir treatment |
Countries
South Korea
Contacts
Primary ContactMyeong Jun Song, Ph D
Outcome results
None listed