Recommendation of lamivudine-to-entecavir switching treatment in chronic hepatitis B responders: Randomized controlled trial

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1872-034X.2011.00807.x/abstract

Recommendation of lamivudine-to-entecavir switching treatment in chronic

hepatitis B responders: Randomized controlled trial

Kentaro Matsuura1,2, Yasuhito Tanaka1,*, Atsunori Kusakabe2, Shuhei Hige5, Jun

Inoue6, Masashi Komatsu7, Tomoyuki Kuramitsu8, Katsuharu Hirano9, Tomoyoshi

Ohno3, Izumi Hasegawa3, Haruhiko Kobashi10, Keisuke Hino11, Yoichi Hiasa12,

Hideyuki Nomura13, Fuminaka Sugauchi4, Shunsuke Nojiri2, Takashi Joh2, Masashi

Mizokami14Article first published online: 18 MAY 2011

DOI: 10.1111/j.1872-034X.2011.00807.x

© 2011 The Japan Society of Hepatology

Issue

Hepatology Research

Volume 41, Issue 6, pages 505–511, June 2011

ABSTRACT

Aim:  In the 2007–2008 guidelines of the study group (Ministry of Health,

Labor and Welfare of Japan), lamivudine (LAM)-continuous treatment was

recommended in patients treated with LAM for more than 3 years who maintained

hepatitis B virus (HBV) DNA less than 2.6 log copies/mL, because in these

patients LAM resistance might exist and switching treatment to entecavir (ETV)

might cause ETV resistance. However, there was no evidence on whether switching

treatment to ETV- or LAM-continuous treatment was better in those patients. In

the present study, we performed a randomized controlled trial of LAM-to-ETV

switching treatment.

Methods:  Twenty-seven patients treated with LAM for more than 3 years whose

HBV DNA levels were less than 2.6 log copies/mL were enrolled and randomly

divided into two groups, LAM-continued group or switching to ETV group. Then, we

examined incidence of virological breakthrough (VBT) and breakthrough hepatitis

(BTH) in each group.

Results:  There was no BTH in any of the patients. VBT was observed in six

patients of the LAM group (6/15, 40%), and no patient of the ETV group (0/11,

0%) (P = 0.02). The differences of the proportion of cumulated VBT using a

log–rank test with Kaplan–Meier analysis were significant between the LAM

and ETV groups (P = 0.025).

Conclusion:  In patients treated with LAM for more than 3 years maintaining

HBV DNA less than 2.6 log copies/mL, switching treatment to ETV is recommended

at least during the 2 years' follow-up period.

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1872-034X.2011.00807.x/abstract

Recommendation of lamivudine-to-entecavir switching treatment in chronic

hepatitis B responders: Randomized controlled trial

Kentaro Matsuura1,2, Yasuhito Tanaka1,*, Atsunori Kusakabe2, Shuhei Hige5, Jun

Inoue6, Masashi Komatsu7, Tomoyuki Kuramitsu8, Katsuharu Hirano9, Tomoyoshi

Ohno3, Izumi Hasegawa3, Haruhiko Kobashi10, Keisuke Hino11, Yoichi Hiasa12,

Hideyuki Nomura13, Fuminaka Sugauchi4, Shunsuke Nojiri2, Takashi Joh2, Masashi

Mizokami14Article first published online: 18 MAY 2011

DOI: 10.1111/j.1872-034X.2011.00807.x

© 2011 The Japan Society of Hepatology

Issue

Hepatology Research

Volume 41, Issue 6, pages 505–511, June 2011

ABSTRACT

Aim:  In the 2007–2008 guidelines of the study group (Ministry of Health,

Labor and Welfare of Japan), lamivudine (LAM)-continuous treatment was

recommended in patients treated with LAM for more than 3 years who maintained

hepatitis B virus (HBV) DNA less than 2.6 log copies/mL, because in these

patients LAM resistance might exist and switching treatment to entecavir (ETV)

might cause ETV resistance. However, there was no evidence on whether switching

treatment to ETV- or LAM-continuous treatment was better in those patients. In

the present study, we performed a randomized controlled trial of LAM-to-ETV

switching treatment.

Methods:  Twenty-seven patients treated with LAM for more than 3 years whose

HBV DNA levels were less than 2.6 log copies/mL were enrolled and randomly

divided into two groups, LAM-continued group or switching to ETV group. Then, we

examined incidence of virological breakthrough (VBT) and breakthrough hepatitis

(BTH) in each group.

Results:  There was no BTH in any of the patients. VBT was observed in six

patients of the LAM group (6/15, 40%), and no patient of the ETV group (0/11,

0%) (P = 0.02). The differences of the proportion of cumulated VBT using a

log–rank test with Kaplan–Meier analysis were significant between the LAM

and ETV groups (P = 0.025).

Conclusion:  In patients treated with LAM for more than 3 years maintaining

HBV DNA less than 2.6 log copies/mL, switching treatment to ETV is recommended

at least during the 2 years' follow-up period.

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1872-034X.2011.00807.x/abstract

Recommendation of lamivudine-to-entecavir switching treatment in chronic

hepatitis B responders: Randomized controlled trial

Kentaro Matsuura1,2, Yasuhito Tanaka1,*, Atsunori Kusakabe2, Shuhei Hige5, Jun

Inoue6, Masashi Komatsu7, Tomoyuki Kuramitsu8, Katsuharu Hirano9, Tomoyoshi

Ohno3, Izumi Hasegawa3, Haruhiko Kobashi10, Keisuke Hino11, Yoichi Hiasa12,

Hideyuki Nomura13, Fuminaka Sugauchi4, Shunsuke Nojiri2, Takashi Joh2, Masashi

Mizokami14Article first published online: 18 MAY 2011

DOI: 10.1111/j.1872-034X.2011.00807.x

© 2011 The Japan Society of Hepatology

Issue

Hepatology Research

Volume 41, Issue 6, pages 505–511, June 2011

ABSTRACT

Aim:  In the 2007–2008 guidelines of the study group (Ministry of Health,

Labor and Welfare of Japan), lamivudine (LAM)-continuous treatment was

recommended in patients treated with LAM for more than 3 years who maintained

hepatitis B virus (HBV) DNA less than 2.6 log copies/mL, because in these

patients LAM resistance might exist and switching treatment to entecavir (ETV)

might cause ETV resistance. However, there was no evidence on whether switching

treatment to ETV- or LAM-continuous treatment was better in those patients. In

the present study, we performed a randomized controlled trial of LAM-to-ETV

switching treatment.

Methods:  Twenty-seven patients treated with LAM for more than 3 years whose

HBV DNA levels were less than 2.6 log copies/mL were enrolled and randomly

divided into two groups, LAM-continued group or switching to ETV group. Then, we

examined incidence of virological breakthrough (VBT) and breakthrough hepatitis

(BTH) in each group.

Results:  There was no BTH in any of the patients. VBT was observed in six

patients of the LAM group (6/15, 40%), and no patient of the ETV group (0/11,

0%) (P = 0.02). The differences of the proportion of cumulated VBT using a

log–rank test with Kaplan–Meier analysis were significant between the LAM

and ETV groups (P = 0.025).

Conclusion:  In patients treated with LAM for more than 3 years maintaining

HBV DNA less than 2.6 log copies/mL, switching treatment to ETV is recommended

at least during the 2 years' follow-up period.

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1872-034X.2011.00807.x/abstract

Recommendation of lamivudine-to-entecavir switching treatment in chronic

hepatitis B responders: Randomized controlled trial

Kentaro Matsuura1,2, Yasuhito Tanaka1,*, Atsunori Kusakabe2, Shuhei Hige5, Jun

Inoue6, Masashi Komatsu7, Tomoyuki Kuramitsu8, Katsuharu Hirano9, Tomoyoshi

Ohno3, Izumi Hasegawa3, Haruhiko Kobashi10, Keisuke Hino11, Yoichi Hiasa12,

Hideyuki Nomura13, Fuminaka Sugauchi4, Shunsuke Nojiri2, Takashi Joh2, Masashi

Mizokami14Article first published online: 18 MAY 2011

DOI: 10.1111/j.1872-034X.2011.00807.x

© 2011 The Japan Society of Hepatology

Issue

Hepatology Research

Volume 41, Issue 6, pages 505–511, June 2011

ABSTRACT

Aim:  In the 2007–2008 guidelines of the study group (Ministry of Health,

Labor and Welfare of Japan), lamivudine (LAM)-continuous treatment was

recommended in patients treated with LAM for more than 3 years who maintained

hepatitis B virus (HBV) DNA less than 2.6 log copies/mL, because in these

patients LAM resistance might exist and switching treatment to entecavir (ETV)

might cause ETV resistance. However, there was no evidence on whether switching

treatment to ETV- or LAM-continuous treatment was better in those patients. In

the present study, we performed a randomized controlled trial of LAM-to-ETV

switching treatment.

Methods:  Twenty-seven patients treated with LAM for more than 3 years whose

HBV DNA levels were less than 2.6 log copies/mL were enrolled and randomly

divided into two groups, LAM-continued group or switching to ETV group. Then, we

examined incidence of virological breakthrough (VBT) and breakthrough hepatitis

(BTH) in each group.

Results:  There was no BTH in any of the patients. VBT was observed in six

patients of the LAM group (6/15, 40%), and no patient of the ETV group (0/11,

0%) (P = 0.02). The differences of the proportion of cumulated VBT using a

log–rank test with Kaplan–Meier analysis were significant between the LAM

and ETV groups (P = 0.025).

Conclusion:  In patients treated with LAM for more than 3 years maintaining

HBV DNA less than 2.6 log copies/mL, switching treatment to ETV is recommended

at least during the 2 years' follow-up period.