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 < 5 log(10) copies/mL and either HBeAg loss or normalization of alanine aminotransferase [ALT] level). Results: The therapeutic response to telbivudine was superior to that of lamivudine in HBeAg-positive (63% vs 48%; P < .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 (< 300 copies/mL) at 55.6% versus 38.5% (P < .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.
[1]Chang Gung Univ, Coll Med, Chang Gung Mem Hosp, Liver Res Unit, Taipei, Taiwan.
[2]Middlemore Hosp, Dept Gastroenterol, Auckland 6, New Zealand.
[3]Alice Ho Miu Ling Nethersole Hosp, Dept Med, Hong Kong, Hong Kong, Peoples R China.
[4]JW Goethe Univ Hosp, Dept Med 1, Frankfurt, Germany.
[5]Third Mil Med Univ, Xi Nan Hosp, Chongqing, Peoples R China.
[6]Queen Mary Hosp, Univ Dept Med, Hong Kong, Hong Kong, Peoples R China.
[7]Univ Toronto, Dept Med, Div Gastroenterol, Toronto, ON, Canada.
[8]Hannover Med Sch, Dept Gastroenterol Hepatol & Endocrinol, D-3000 Hannover, Germany.
[9]Calif Pacific Med Ctr, Dept Liver Transplantat, San Francisco, CA USA.
[10]Jilin Univ, Hosp 1, Dept Hepatol, Guangzhou, Guangdong, Peoples R China.
[11]Univ Calif Los Angeles, Sch Med, Pfleger Liver Inst, Los Angeles, CA USA.
[12]Pochon CHA Univ, Bundang Cha Hosp, Dept Internal Med, Kyonggi Do, South Korea.
[13]Istanbul Univ, Istanbul, Turkey.
[14]Univ Calif Los Angeles, David Geffen Sch Med, Phleger Liver Inst, Div Digest Dis, Los Angeles, CA 90095 USA.
[15]Univ Athens, Hippokrat Hosp, Sch Med, Dept Internal Med 2, Athens, Greece.
[16]Zhejiang Univ, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China.
[17]Idenix Pharmaceut, Cambridge, MA USA.
[18]Novartis AG, Basel, Switzerland.
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