Hepatitis B
Conditions
Brief summary
To evaluate various markers of renal function and bone density after the switch to Tenofovir alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with Tenofovir disoproxil fumarate (TDF) .
Detailed description
The investigators have previously reported the prevalence of abnormal renal tubular reabsorption of phosphate among CHB patients treated with more than 18 months of TDF to be 48%. Renal tubular dysfunction associated with TDF may be reversible when TDF is discontinued 4. Recently, TAF 25 mg daily was shown to have comparable efficacy to TDF 300 mg with respect to viral suppression in both HBeAg positive and HBeAg negative CHB patients (studies 110 and 108) at 48 weeks of therapy. As speculated, the systemic exposure to tenofovir was significantly less in patients exposed to TAF compared to those on TDF with strikingly less effects noted in a variety of renal and bone parameters for individuals receiving TAF. Notably, however, the question remains to what if any improvements may be seen in CHB patients switched from TDF to TAF. The investigators propose a prospective open label study to evaluate various markers of renal function and bone density in 80 CHB patients who are currently treated with TDF who are switched to TAF.
Interventions
Patients on TDF will be switched to TAF
Sponsors
Asian Pacific Liver Center at Coalition of Inclusive Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with chronic hepatitis B (who are either HBeAg reactive or non-reactive) * Treated with TDF with unquantifiable Hepatitis B Virus (HBV) DNA by a sensitive Polymerase chain reaction (PCR) assay for a minimum of 6 months * No prior nucleos(t)ide exposure prior to treatment with TDF * Treatment with TDF for a minimum of 12 months
Exclusion criteria
* HIV Infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measure renal function after switch to TAF | one year | Kidney function will be measured by blood and urine to compare abnormal results before and after switching to TAF. |
| measure bone density after switch to TAF | one year | Bone density will also be measured to compare T score and Z score before and after switching to TAF |
Outcome results
None listed