Hepatitis B, Chronic
Conditions
Keywords
retrospective, naïve Chronic Hepatitis B (CHB) patients, cohort study, lamivudine
Brief summary
This is to evaluate the proportion of subjects who show good responses to LAM treatment in Korea.
Detailed description
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.
Interventions
OTHERNo intervention
This study is retrospective chart review
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment | 5years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment | 4 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 |
| Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment | 5 years |
Countries
South Korea
Outcome results
None listed