At a glance
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Prospective Randomized Study for the Comparison of Adding Adefovir Dipivoxil and Switching to Entecavir in Patients With Lamivudine-resistant Chronic Hepatitis B
In Brief
A Phase 4 clinical trial evaluating combination of lamivudine+adefovir vs entecavir for Chronic Hepatitis B. Completed, enrolled 219 participants across 2 sites.
Detailed Summary
Antiviral resistance mutations limit the efficacy of therapy for chronic hepatitis B. At year 2, resistance to adefovir may occur as high as 25% in patients with history of lamivudine resistance. Resistance to entecavir is reported to be 10% in lamivudine refractory patients during the same period. However, combination of lamivudine and adefovir decreased the adefovir resistance rate as low as 0% in the recent studies. By overcoming the antiviral resistance, the efficacy of therapy will be maximized. This study is intended to compare the efficacy of two strategies, combination of lamivudine and adefovir vs. entecavir monotherapy in patients with lamivudine resistance.
Study Details
Timeline
Interventions
Lamivudine 100 mg/day, Adefovir 10 mg/day, Entecavir 0.5 mg/day