NCT01546116

Adefovir and Lamivudine for Entecavir Resistance (ALTER Study)

Efficacy of Adefovir and Lamivudine Combination Therapy in Patients With Entecavir Resistance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Korea University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* 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.

Detailed description

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	ADEFOVIR, LAMIVUDINE	Adefovir/10mg tablet/once a day/52week Lamivudine/100mg tablet/once a day/52week

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-02-01
• Completion: 2014-02-01
• First posted: 2012-03-07
• Last updated: 2014-02-17

Locations

9 sites across 1 country: South Korea