Efficacy and safety of prolonged 3-year telbivudine treatment in patients with chronic hepatitis B

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1478-3231.2011.02490.x/abstract

Efficacy and safety of prolonged 3-year telbivudine treatment in patients with

chronic hepatitis B

J. Gane1, Yuming Wang2, Yun-Fan Liaw3, JinLin Hou4, Satawat Thongsawat5,

MoBin Wan6, Young M. Moon7, JiDong Jia8, You C. Chao9, Junqi Niu10,

Leung11, Didier 12, Chao Wei Hsu13, Weibin Bao14, 15,

Claudio Avila15

Article first published online: 16 MAR 2011

DOI: 10.1111/j.1478-3231.2011.02490.x

© 2011 Wiley & Sons A/S

Issue

Liver International

Volume 31, Issue 5, pages 676–684, May 2011

Abstract

Background: In the GLOBE trial, telbivudine demonstrated superior efficacy to

lamivudine at 2 years in patients with chronic hepatitis B (CHB).

Aims: To investigate the long-term efficacy and safety of telbivudine in the

telbivudine-treated cohort from the GLOBE trial.

Methods: Virological and biochemical responses were assessed in 213

HBeAg-positive and 186 HBeAg-negative CHB patients who continued telbivudine

treatment for 3 years.

Results: Undetectable hepatitis B virus DNA and HBeAg seroconversions were

achieved by 77 and 37% of HBeAg-positive patients respectively. Cumulative HBeAg

seroconversion rate was 46%. HBeAg seroconversion was sustained at 52 weeks off

therapy in 84% of the patients enrolled in the off-treatment follow-up arm of

the study. Undetectable viraemia and normal alanine aminotransferase (ALT)

levels at 3 years were achieved by 85 and 83% of HBeAg-negative patients

respectively. Genotypic resistance rates for the study population who continued

therapy during the third year were 11.3 in HBeAg-positive and 6.5% in

HBeAg-negative patients. Patients with undetectable viraemia at treatment week

24 had optimal outcomes at 3 years. In the HBeAg-positive population, cumulative

HBeAg seroconversion occurred in 58%. Resistance rates for HBeAg-positive and

HBeAg-negative patients were 3.6 and 6.2% respectively. The telbivudine safety

profile during prolonged therapy was similar to that in the GLOBE trial.

Conclusions: Three years of telbivudine treatment yielded high rates of viral

suppression and ALT normalization with a favourable safety profile. High rates

of HBeAg seroconversion were achieved with prolonged telbivudine therapy and

were sustained in the majority of patients over 52 weeks off therapy.

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1478-3231.2011.02490.x/abstract

Efficacy and safety of prolonged 3-year telbivudine treatment in patients with

chronic hepatitis B

J. Gane1, Yuming Wang2, Yun-Fan Liaw3, JinLin Hou4, Satawat Thongsawat5,

MoBin Wan6, Young M. Moon7, JiDong Jia8, You C. Chao9, Junqi Niu10,

Leung11, Didier 12, Chao Wei Hsu13, Weibin Bao14, 15,

Claudio Avila15

Article first published online: 16 MAR 2011

DOI: 10.1111/j.1478-3231.2011.02490.x

© 2011 Wiley & Sons A/S

Issue

Liver International

Volume 31, Issue 5, pages 676–684, May 2011

Abstract

Background: In the GLOBE trial, telbivudine demonstrated superior efficacy to

lamivudine at 2 years in patients with chronic hepatitis B (CHB).

Aims: To investigate the long-term efficacy and safety of telbivudine in the

telbivudine-treated cohort from the GLOBE trial.

Methods: Virological and biochemical responses were assessed in 213

HBeAg-positive and 186 HBeAg-negative CHB patients who continued telbivudine

treatment for 3 years.

Results: Undetectable hepatitis B virus DNA and HBeAg seroconversions were

achieved by 77 and 37% of HBeAg-positive patients respectively. Cumulative HBeAg

seroconversion rate was 46%. HBeAg seroconversion was sustained at 52 weeks off

therapy in 84% of the patients enrolled in the off-treatment follow-up arm of

the study. Undetectable viraemia and normal alanine aminotransferase (ALT)

levels at 3 years were achieved by 85 and 83% of HBeAg-negative patients

respectively. Genotypic resistance rates for the study population who continued

therapy during the third year were 11.3 in HBeAg-positive and 6.5% in

HBeAg-negative patients. Patients with undetectable viraemia at treatment week

24 had optimal outcomes at 3 years. In the HBeAg-positive population, cumulative

HBeAg seroconversion occurred in 58%. Resistance rates for HBeAg-positive and

HBeAg-negative patients were 3.6 and 6.2% respectively. The telbivudine safety

profile during prolonged therapy was similar to that in the GLOBE trial.

Conclusions: Three years of telbivudine treatment yielded high rates of viral

suppression and ALT normalization with a favourable safety profile. High rates

of HBeAg seroconversion were achieved with prolonged telbivudine therapy and

were sustained in the majority of patients over 52 weeks off therapy.