Lamivudine(LAM) Good Responder Study

Study Overview
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Brief Summary
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This is to evaluate the proportion of subjects who show good responses to LAM treatment in Korea.

Detailed Description
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This is to evaluate the proportion of subjects who show good responses to LAM treatment such as HBV DNA negativity, HBV DNA less than 4 log, no resistant mutation, HBeAg seroconversion and normalization of ALT in naïve CHB patients with certain pre-treatment characteristics, i.e. HBV DNA less than 9log copies per ml and ALT more than 2 times ULN in HBeAg positive subjects, HBV DNA less than 7log copies per ml and elevated ALT in HBeAg negative subjects.

Official Title
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A Retrospective Cohort Study to Evaluate the Rate of Good Responses to Lamivudine (LAM) Treatment in naïve Chronic Hepatitis B (CHB) Patients With Certain Pre-treatment Characteristics

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CHB or liver cirrhosis due to Hepatitis B virus who had started LAM between Jan 1, 2003 and Dec 31, 2004 and maintained LAM at least 6 months HBsAg positive at least for 6 months at the beginning of observation HBV DNA positive before LAM administration Subjects with certain pre-treatment laboratory findings as follows; HBV DNA less than 9log copies per ml and ALT more than 2 times ULN in HBeAg positive patients, HBV DNA less than 7log copies per ml and elevated ALT in HBeAg negative patients Exclusion Criteria: Documented co-infection with HCV, HIV at the beginning of LAM treatment Decompensated liver cirrhosis at the beginning of LAM treatment HCC at the beginning of LAM treatment

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| CHB patients who started LAM as an initial antiviral treatment<br>CHB patients who started LAM as an initial antiviral treatment at least 5 years prior to this investigation | Other: No intervention<br>* This study is retrospective chart review<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment |  | 5years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment |  | 4 years | 
| Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment |  | 5 years | 
| Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment |  | 5 years | 
| Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment |  | 5 years | 
| Proportion of subjects showing ALT normalization during 5 years of LAM treatment |  | 5 years | 
| Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retrospective, naïve Chronic Hepatitis B (CHB) patients, cohort study, lamivudine