Overview

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B

Status:
Active, not recruiting
Trial end date:
2024-01-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Tenofovir
Criteria
Key Inclusion Criteria:

- Ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of study procedures

- Adult males and non-pregnant, non-lactating females

- Documented evidence of chronic HBV infection

- Hepatitis e antigen (HBeAg)-negative, chronic hepatitis B with all of the following:

- HBeAg-negative and hepatitis B e antibody (HBeAb) positive at screening

- Screening HBV DNA ≥ 2 x 10^4 IU/mL

- Screening serum alanine aminotransferase (ALT) level > 60 U/L (males) or > 38 U/L
(females) and ≤ 10 x the upper limit of the normal range (ULN)

- Treatment-naive participants (defined as < 12 weeks of oral antiviral treatment with
any nucleoside or nucleotide analogue), OR treatment-experienced participants (defined
as participants meeting all entry criteria [including HBV DNA and serum ALT criteria]
and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue)

- Previous treatment with interferon (pegylated or non pegylated) must have ended at
least 6 months prior to the baseline visit.

- Adequate renal function

- Normal ECG

Key Exclusion Criteria:

- Females who are breastfeeding

- Males and females of reproductive potential who are unwilling to use an "effective",
protocol-specified method(s) of contraception during the study

- Co-infection with hepatitis C virus, HIV, or hepatitis D virus

- Evidence of hepatocellular carcinoma

- Any history of, or current evidence of, clinical hepatic decompensation

- Abnormal hematological and biochemical parameters, including aspartate
aminotransferase (AST) > 10 x ULN

- Received solid organ or bone marrow transplant

- History of malignancy within the past 5 years, with the exception of specific cancers
that are cured by surgical resection; individuals under evaluation for possible
malignancy are not eligible

- Currently receiving therapy with immunomodulators (eg, corticosteroids),
investigational agents, nephrotoxic agents, or agents capable of modifying renal
excretion

- Individuals receiving ongoing therapy with drugs not to be used with tenofovir
alafenamide or tenofovir disoproxil fumarate or individuals with a known
hypersensitivity to study drugs, metabolites, or formulation excipients

- Current alcohol or substance abuse judged by the investigator to potentially interfere
with participant compliance

- Any other clinical condition or prior therapy that, in the opinion of the
Investigator, would make the participant unsuitable for the study or unable to comply
with dosing requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply.