Lamivudine(LAM) Good Responder Study

ViiV Healthcare1 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis B, Chronic

Interventions

No interventionOTHER

This study is retrospective chart review

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. HBsAg positive at least for 6 months at the beginning of observation 3. HBV DNA positive before LAM administration 4. 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: 1. Documented co-infection with HCV, HIV at the beginning of LAM treatment 2. Decompensated liver cirrhosis at the beginning of LAM treatment 3. HCC at the beginning of LAM treatment

Locations (1)

GSK Investigational Site

Kangwon-do, South Korea

Outcomes

Primary Outcomes

Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment

Time frame: 5years

Secondary Outcomes

Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment

Time frame: 4 years

Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment

Time frame: 5 years

Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment

Time frame: 5 years

Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment

Time frame: 5 years

Proportion of subjects showing ALT normalization during 5 years of LAM treatment

Time frame: 5 years

Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment

Time frame: 5 years

Data from ClinicalTrials.gov

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