Entecavir to Telbivudine Switch Therapy in Entecavir-Treated Patients with Undetectable Hepatitis B Viral DNA.
OBJECTIVE
This study examined 2-year outcome of consecutive therapy using entecavir (ETV) followed by telbivudine (LdT) in subjects with undetectable hepatitis B virus (HBV) DNA level and normal alanine aminotransferase level after the initial 6 months of ETV treatment.


METHODS
Sixty subjects were randomized to continue with ETV or switch to LdT. Significant difference in baseline characteristics was not found between the two groups. Persistent HBV DNA level of 20-60 IU/mL in three consecutive samples collected three months apart or singly measured HBV DNA level of >60 IU/mL was defined as virological rebound.


RESULTS
During 96 weeks of follow-up, all subjects of the ETV-only group (n=30) resulted in undetectable HBV DNA level. On the other hand, 83.3% (n=25) of the LdT-switched group showed treatment success. Virological rebound time varied from week 24 to 84 after switching to LdT. HBV DNA level was 180 to 2940 IU/mL at rebound time. All subjects with virological rebound (n=5) showed drug-resistant mutation: three had mutation rtM204I, and two had mutation rtM204V. Consecutive treatment using ETV followed by LdT showed virological rebound in 16.7% of subjects during 96 weeks of follow-up. HBV DNA negativity during initial ETV therapy could not be achieved in patients who switched to LdT.


CONCLUSIONS
Consecutive treatment using ETV followed by lamivudine was ineffective for treating chronic hepatitis B. LdT was found as a more potent antiviral agent than lamivudine. However, this conclusion requires larger-scale, long-term prospective reviews of the treatment effects of ETV-LdT switch therapy.
Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
Dong Hyun
DH
Kim
Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
Jong Won
JW
Choi
Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
Jeong Hun
JH
Seo
Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
Yong Suk
YS
Cho
Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
Sun Young
SY
Won
Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
Byung Kyu
BK
Park
Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
Han Ho
HH
Jeon
Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
Sang Yun
SY
Shin
Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea. cklee33@nhimc.or.kr.
Chun Kyon
CK
Lee
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood / Q000235:genetics; D024882:Drug Resistance, Viral / Q000235:genetics; D057915:Drug Substitution; D005260:Female; D005500:Follow-Up Studies; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006515:Hepatitis B virus / Q000187:drug effects* / Q000235:genetics / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009154:Mutation; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D000077712:Telbivudine; D013936:Thymidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D004279:DNA, Viral; D000077712:Telbivudine; C413685:entecavir; D006147:Guanine; D000410:Alanine Transaminase; D013936:Thymidine
Hepatitis B virus; entecavir; telbivudine