On-treatment serum HBsAg level is predictive of sustained off-treatment virologic response to telbivudine in HBeAg-positive chronic hepatitis B patients.
BACKGROUND
Effective management of chronic hepatitis B infection is still very challenging, despite decades of clinical research. Telbivudine is one of the most frequently used antiviral drug at the current stage, but its long-term effectiveness, particularly at off-treatment, is still unclear.


OBJECTIVE
To assess on-treatment HBsAg kinetics in patients treated with telbivudine for 2 years, and predicting sustained virologic response (SR) at 2 years off-treatment.


METHODS
Serum HBV DNA/HBsAg levels were assessed from 17 HBeAg+ patients treated with telbivudine 600 mg/day for 104 weeks, at baseline, weeks 24, 52 and 104, as well as during off-treatment follow-up.


RESULTS
HBsAg levels <2 log(10)IU/ml at treatment week 104 were highly predictive of SR (i.e., HBV DNA <300 copies/ml, HBeAg seroconversion, ALT normalization) at 2 years off-treatment (positive predictive value [PPV], 93%; negative predictive value [NPV], 100%). HBsAg levels consistently declined from baseline only in patients achieving SR during 2 years off-treatment. At weeks 24 and 52, HBsAg decline rate was a better predictor of off-treatment response than HBV DNA decline rate. HBsAg decline rates of >0.8 and >1 log(10)IU/ml at treatment weeks 24 and 52 were predictive of SR (PPV, 75%; NPV, 86% at week 24; PPV, 75%; NPV, 86% at week 52).


CONCLUSIONS
Serum HBsAg levels <2 log(10)IU/ml at treatment week 104 are highly predictive of SR to telbivudine at 2 years off-treatment. HBsAg decline rate at on-treatment weeks 24 and 52 from baseline were also more predictive of SR than HBV DNA decline rate.
Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, People's Republic of China.
Wei
W
Cai
Qing
Q
Xie
Baoyan
B
An
Hui
H
Wang
Xiaqiu
X
Zhou
Guomin
G
Zhao
Qing
Q
Guo
Ruiying
R
Gu
Shisan
S
Bao
D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006513:Hepatitis B e Antigens / Q000097:blood*; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology*; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009705:Nucleosides / Q000627:therapeutic use*; D011237:Predictive Value of Tests; D011744:Pyrimidinones / Q000627:therapeutic use*; D012372:ROC Curve; D018709:Statistics, Nonparametric; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D009705:Nucleosides; D011744:Pyrimidinones; D000077712:Telbivudine; D013936:Thymidine