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

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

chronic hepatitis B

Liver International, 04/11/2011 Clinical Article

Gane EJ et al. - 3 years of telbivudine treatment yielded high rates of viral

suppression and alanine aminotransferase (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.

Methods• Virological and biochemical responses were assessed in patients who

continued telbivudine treatment for 3 years.

• 213 HBeAg-positive and 186 HBeAg-negative chronic hepatitis B (CHB)

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 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.

____________________________________________________________________________

http://www.ingentaconnect.com/content/mksg/liv/2011/00000031/00000005/art00011

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

chronic hepatitis B

Authors: Gane, J.1; Wang, Yuming2; Liaw, Yun-Fan3; Hou, JinLin4;

Thongsawat, Satawat5; Wan, MoBin6; Moon, Young M.7; Jia, JiDong8; Chao, You C.9;

Niu, Junqi10; Leung, 11; , Didier12; Hsu, Chao Wei13; Bao, Weibin14;

, 15; Avila, Claudio15

Source: Liver International, Volume 31, Number 5, May 2011 , pp. 676-684(9)

Publisher: Wiley-Blackwell

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.

DOI: 10.1111/j.1478-3231.2011.02490.x

Affiliations:1: New Zealand Liver Unit, Auckland City Hospital, Auckland, New

Zealand 2: Department of Infectious Diseases, Southwest Hospital, Third Military

Medical University, Chongqing, China 3: Liver Research Unit, Chang Gung Memorial

Hospital, Chang Gung University College of Medicine, Taipei, Taiwan 4:

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern

Medical University, Guangzhou, China 5: Department of Internal Medicine, Chiang

Mai University, Chiang Mai, Thailand 6: Department of Infectious Diseases,

Shanghai Changhai Hospital, Shanghai, China 7: Department of Internal Medicine,

Kwan Dong University College of Medicine, Goyang, Korea 8: Department of

Gastroenterology, Beijing Friendship Hospital, Capital Medical University,

Beijing, China 9: Division of Gastroenterology, Tri-Service General Hospital,

National Defense Medical Center, Taipei, Taiwan 10: Department of Liver

Diseases, First Hospital, University of Jilin, Changchun, China 11: Department

of Medicine, Alice Ho Miu Ling Nethersole Hospital, Hong Kong, China 12: AP-HP

Hôpital Brousse, Centre Hépato-Biliaire, Villejuif, France 13: Chang Gung

Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan 14:

Novartis Pharmaceuticals, East Hanover, NJ, USA 15: Novartis AG, Basel,

Switzerland

Publication date: 2011-05-01