Tenofovir in Asian Chronic Hepatitis B Patients
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|ClinicalTrials.gov Identifier: NCT01728935|
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : December 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: Tenofovir disoproxil||Not Applicable|
Recent multi-center trials have shown tenofovir disoprovil fumarate (TDF) demonstrating potent antiviral efficacy in both nucleoside-naive and -experienced chronic hepatitis B (CHB) patients. At present, there has been no identifiable amino acid substitutions associated with resistance to TDF.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Serologic and Virologic Outcomes of Tenofovir in Asian Chronic Hepatitis B Patients With Prior Nucleoside Analogue Exposure|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||March 2013|
Tenofovir disoproxil 300mg daily
Drug: Tenofovir disoproxil
Tenofovir disoproxil 300mg daily
Other Name: Viread
- Serum HBV DNA levels [ Time Frame: 3 Years ]
- Resistance Profile [ Time Frame: 3 Years ]Performed using a Line Probe Assay (LiPA)
- HBsAg levels [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728935
|Department of Medicine, The University of Hong Kong, Queen Mary Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Man-Fung Yuen, MD||The University of Hong Kong|