Chronic Hepatitis B Clinical Trial
Official title:
Efficacy of Adefovir and Lamivudine Combination Therapy in Patients With Entecavir Resistance
- Entecavir has been one of the option for treatment of lamivudine resistant chronic
hepatitis B (CHB).
- In case of entecavir resistance, adefovir could be used. However, sequential
monotherapy may result in multidrug resistance.
- It is thought that adefovir and lamivudine combination therapy reduce the risk of
adefovir resistance, thereby continued therapy will lead to suppression of hepatitis B
virus (HBV) DNA to be undetectable in patients with entecavir resistance.
- This study aim to evaluate the efficacy of adefovir and lamivudine combination therapy
in CHB patients with entecavir resistance.
Entecavir is a potent antiviral agent for the treatment of chronic hepatitis B (CHB).
However, the incidence of entecavir resistance increases over 50% at 5th year in
lamivudine-refractory CHB patients. Considering cross resistance profile, adefovir is a good
option for managing entecavir resistance. However adefovir monotherapy may lead to adefovir
resistance, because entecavir resistant hepatitis B virus (HBV) retain lamivudine
resistance. Previously, combination of adefovir and lamivudine was reported to be effective
in a patient with entecavir resistance, but only as a case report form. No further data are
available on this combination therapy in a sufficient number of patients. It is thought that
adefovir and lamivudine combination therapy reduce the risk of adefovir resistance, thereby
continued combination treatment will result in suppression of HBV DNA to be undetectable in
patients with entecavir resistance.
The aim of this study is to evaluate the efficacy of adefovir and lamivudine combination
therapy in CHB patients with entecavir resistance.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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