TAF Switch Study in Hepatitis B Monoinfection

Phase 4

• Conditions: Hepatitis B
• Interventions: Drug: Tenofovir alafenamide fumarate

• Registration Number: NCT02957994
• Lead Sponsor: Asian Pacific Liver Center at Coalition of Inclusive Medicine

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.

Study Timeline

• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-08
• Study Start: 2016-12-22
• Status Verified: 2017-06
• Primary Completion: 2017-06-21
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-06-29
• Study Completion: 2017-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAF Arm	Tenofovir alafenamide fumarate	Tenofovir alafenamide fumarate 25mg, 1 tablet once daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
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