Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders

Study Overview
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Brief Summary
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We propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 48 weeks of entecavir following partial response to adefovir. The aim of the study is to describe sequential virologic response to adefovir and entecavir.

Detailed Description
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Amendment was made, and approved by WIRB in January 2009, to this protocol: We propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 96 weeks of entecavir following adefovir treatment. The aim of the study is to describe sequential virologic response to adefovir and entecavir.

Official Title
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HBV Viral Suppression by Entecavir in Adefovir Partial Responders

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: Entecavir


Participation Criteria
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Eligibility Criteria
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KEY INCLUSION CRITERIA: Age 18 years or older All genders and ethnicity Positive HBsAg HBeAg positive and negative Pretreatment HBV DNA of 10,000 copies/mL or higher (for purposes of this study, both copies and equivalent IU measurements will be recorded and analyzed) Patients who are switched to, or prescribed, entecavir after treatment with adefovir for at least 12 weeks by the providing physician. Patients with and without prior lamivudine exposure will be enrolled but enrollment of lamivudine experienced cases will be limited to no more than 30 patients total KEY EXCLUSION CRITERIA: Patients who refused to consent to the study Patients younger than 18 Vulnerable subjects such as pregnant women, prisoners, employees, patients with significant cognitive deficits. Patients with prior exposure to another nucleoside for more than 2 weeks. Those with prior exposure to lamivudine will be enrolled under conditions detailed above. HIV co-infection HCV co-infection HDV co-infection Recipients of solid organ transplantation Patients who receive high-dose steroid (60 mg/d or higher and for longer than 10 days)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Persistent viremia after 48 weeks or longer. | Drug: Entecavir<br>* 0.5 or 1 mg dose qd<br>* Other names: Baraclude;|
| Group 2<br><2 log IU/mL drop from initial HBVDNA after 12 weeks of adefovir | Drug: Entecavir<br>* 0.5 or 1 mg dose qd<br>* Other names: Baraclude;|
| Group 3<br>Patients who responded to adefovir and were switched to entecavir. | Drug: Entecavir<br>* 0.5 or 1 mg dose qd<br>* Other names: Baraclude;|
| Group 4<br>Patients with 160 copies/mL (100 IU/mL) or higher at the time of medication switch. | Drug: Entecavir<br>* 0.5 or 1 mg dose qd<br>* Other names: Baraclude;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA PCR after 12 weeks of entecavir from the time of medication switching: percent of patients with <2log drop in HBV DNA and percent of patients with complete viral suppression during adefovir versus during entecavir. |  | 48 weeks or after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA PCR after 24 weeks of entecavir from the time of medication switching. |  | 48 weeks or after | 
| HBV DNA PCR after 48 weeks of entecavir from the time of medication switching. |  | 48 weeks or after | 
| BR and CR at 24 and 48 weeks of therapy with entecavir. |  | 48 weeks or after. | 
| BR and CR for longer duration of therapy if available. |  | 48 weeks or after. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV, Hepatitis B, Treatment