2-Year GLOBE Trial Results: Telbivudine Is Superior to Lamivudine in Patients With Chronic Hepatitis B

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Gastroenterology. 2008 Nov 1. [Epub ahead of print]

2-Year GLOBE Trial Results: Telbivudine Is Superior to Lamivudine in Patients

With Chronic Hepatitis B.

Liaw YF, Gane E, Leung N, Zeuzem S, Wang Y, Lai CL, Heathcote EJ, Manns M,

Bzowej N, Niu J, Han SH, Hwang SG, Cakaloglu Y, Tong MJ, Papatheodoridis G, Chen

Y, Brown NA, Albanis E, Galil K, Naoumov NV; The GLOBE Study Group.

Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei,

Taiwan.

BACKGROUND & AIMS: The GLOBE trial has compared the efficacy and safety of

telbivudine versus lamivudine treatment over 2 years in patients with chronic

hepatitis B. METHODS: Hepatitis B e antigen (HBeAg)-positive (n = 921) and

HBeAg-negative (n = 446) patients received telbivudine or lamivudine once daily

for 104 weeks. The primary outcome, assessed in the intent-to-treat population,

was therapeutic response (hepatitis B virus DNA < .001) and HBeAg-negative (78%

vs 66%; P = .007) patients. HBeAg-positive patients given telbivudine also had

better outcomes compared with lamivudine in terms of nondetectable viremia (<

..001), HBeAg loss at 35.2% versus 29.2% (P = .056), and viral resistance at

25.1% versus 39.5% (P < .001). Hepatitis B e antigen seroconversion was 29.6%

versus 24.7% (P = .095) in all patients and 36% versus 27% (P = .022) in

patients with baseline ALT level>/=2 times normal. Telbivudine-treated

HBeAg-negative patients showed higher rates of nondetectable viremia compared

with lamivudine at 82.0% versus 56.7% (P < .001) and less resistance at 10.8%

versus 25.9% (P < .001). Adverse events occurred with similar frequency, whereas

grade 3/4 increases in creatine kinase levels were more common in patients given

telbivudine (12.9% vs 4.1%, P < .001). Multivariate logistic regression analyses

identified telbivudine treatment, among other variables, as an independent

predictor of better week 104 outcomes. CONCLUSIONS: Telbivudine is superior to

lamivudine in treating patients with chronic hepatitis B over a 2-year period.

PMID: 19027013 [PubMed - as supplied by publisher]

[Guest guest]

Gastroenterology. 2008 Nov 1. [Epub ahead of print]

2-Year GLOBE Trial Results: Telbivudine Is Superior to Lamivudine in Patients

With Chronic Hepatitis B.

Liaw YF, Gane E, Leung N, Zeuzem S, Wang Y, Lai CL, Heathcote EJ, Manns M,

Bzowej N, Niu J, Han SH, Hwang SG, Cakaloglu Y, Tong MJ, Papatheodoridis G, Chen

Y, Brown NA, Albanis E, Galil K, Naoumov NV; The GLOBE Study Group.

Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei,

Taiwan.

BACKGROUND & AIMS: The GLOBE trial has compared the efficacy and safety of

telbivudine versus lamivudine treatment over 2 years in patients with chronic

hepatitis B. METHODS: Hepatitis B e antigen (HBeAg)-positive (n = 921) and

HBeAg-negative (n = 446) patients received telbivudine or lamivudine once daily

for 104 weeks. The primary outcome, assessed in the intent-to-treat population,

was therapeutic response (hepatitis B virus DNA < .001) and HBeAg-negative (78%

vs 66%; P = .007) patients. HBeAg-positive patients given telbivudine also had

better outcomes compared with lamivudine in terms of nondetectable viremia (<

..001), HBeAg loss at 35.2% versus 29.2% (P = .056), and viral resistance at

25.1% versus 39.5% (P < .001). Hepatitis B e antigen seroconversion was 29.6%

versus 24.7% (P = .095) in all patients and 36% versus 27% (P = .022) in

patients with baseline ALT level>/=2 times normal. Telbivudine-treated

HBeAg-negative patients showed higher rates of nondetectable viremia compared

with lamivudine at 82.0% versus 56.7% (P < .001) and less resistance at 10.8%

versus 25.9% (P < .001). Adverse events occurred with similar frequency, whereas

grade 3/4 increases in creatine kinase levels were more common in patients given

telbivudine (12.9% vs 4.1%, P < .001). Multivariate logistic regression analyses

identified telbivudine treatment, among other variables, as an independent

predictor of better week 104 outcomes. CONCLUSIONS: Telbivudine is superior to

lamivudine in treating patients with chronic hepatitis B over a 2-year period.

PMID: 19027013 [PubMed - as supplied by publisher]