Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
141 participants
INTERVENTIONAL
2008-04-30
2013-03-31
Brief Summary
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Detailed Description
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Since TDF and adefovir (ADV), another licensed drug for CHB, belong to same molecular group, acyclic phosphonate, there had been various studies investigating the efficacy of TDF in ADV-resistant patients. The efficacy of tenofovir in this group of patients is conflicting. While several studies have shown TDF achieving similar viral suppression when compared to CHB patients without ADV-resistance , another study found that patients with the signature ADV mutations of rtA181V/T and /or rtN236T responded suboptimally to TDF. For all published studies, the number of patients with documented genotypic resistance to adefovir is actually small (n = 17-40), and therefore, further studies in this area are required.
Another interesting point to note was the relatively high rate of hepatitis B surface antigen (HBsAg) seroclearance found in patients taking TDF. The cumulative rate of HBsAg seroclearance up in hepatitis B e antigen (HBeAg)-positive was 10% after 4 years . However, the same study did not find any HBeAg-negative patients achieving HBsAg seroclearance. In addition, studies on TDF were mainly performed in Caucasian patients, the majority being genotypes A and D. A preliminary study performed in Asian patients, predominantly genotypes B and C, did not discover any cases of HBsAg seroclearance . Given the majority of the CHB population is found in Asia, further studies are needed to clarify if HBsAg seroclearance by nucleoside / nucleotide analogues is potentially achievable using TDF.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tenofovir disoproxil
Tenofovir disoproxil 300mg daily
Tenofovir disoproxil
Tenofovir disoproxil 300mg daily
Interventions
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Tenofovir disoproxil
Tenofovir disoproxil 300mg daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Commenced on tenofovir for chronic hepatitis B
3. Exposure to other nucleoside analogues before starting TDF
Exclusion Criteria
2. Significant alcohol intake (\> 20 grams per day)
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
The University of Hong Kong
OTHER
Responsible Party
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Principal Investigators
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Man-Fung Yuen, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Department of Medicine, The University of Hong Kong, Queen Mary Hospital
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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UW 11-241
Identifier Type: OTHER
Identifier Source: secondary_id
TDF-HKU
Identifier Type: -
Identifier Source: org_study_id