Chronic Hepatitis B Clinical Trial
Official title:
Randomized Trial of Tenofovir Versus Lamivudine Plus Adefovir in Lamivudine Plus Adefovir Treated Lamivudine-resistant Chronic Hepatitis B Patients With Undetectable Hepatitis B Virus DNA.
This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B patients with Undetectable Hepatitis B Virus DNA
Recently, in Korea, long-term medication of antiviral agents and their resulting resistance
expression have been the most serious cause of failure to treat chronic hepatitis B. Exp.
In particular, the annual resistance rate to lamivudine currently widely being used in Korea
amounts to about 15 to 20 percents and the rate is expected to reach 70 to 80 percent in
four to five years.
The guidelines by the American Association for the Study of Liver Disease (AASLD) and the
European Association for the Study of the Liver (EASL) recommend a combination therapy with
adefovir or tenofovir for patients with lamivudine resistant HBV .
In Korea, however, in case of combined prescription of lamivudine and adefovir, only one of
them is covered by the health insurance and therefore many patients are difficult to
continue treatment due to their economic conditions.
Tenofovir that has been developed most recently and will be placed on sale sooner or later
in Korea has strong antiviral effects, causes little or no emergence of resistant viruses,
and is known to have lower nephrotoxicity than adefovir.
In particular, several papers reported that tenofovir has effective and sustaining antiviral
effects in patients who had other antiviral agents resistant HBV as well as those who
received initial treatment. This shows that patients only with lamivudine resistant HBV can
be treated only with tenofovir without a combination therapy and when they have low levels
of HBV DNA, treatment is relatively effective despite their resistance to adefovir.
Therefore, it is considered that tenofovir switching therapy in patients with undetectable
HBV DNA after lamivudine plus adefovir combination therapy to maintain their virus response.
The results of this study will provide a rationale for switch from lamivudine plus adefovir
to tenofovir monotherapy in such patients.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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