PURPOSE: Current Japanese guidelines recommend that patients should be switched from lamivudine to entecavir when they meet certain criteria. This analysis examines the efficacy and safety of long-term entecavir therapy in patients who were switched to entecavir after 24 weeks' lamivudine therapy in Japanese studies ETV-047 and ETV-060. METHODS: The Phase II Japanese study ETV-047 assessed the efficacy of different entecavir doses when compared with lamivudine. A total of 33 Japanese patients who received lamivudine 100 mg daily in ETV-047 entered the open-label rollover study ETV-060 and subsequently received treatment with entecavir 0.5 mg daily. Hepatitis B virus (HBV) DNA suppression, alanine aminotransferase (ALT) normalization, hepatitis B e antigen (HBeAg) seroconversion, and resistance were evaluated among patients with available samples for up to 96 weeks. Safety was assessed throughout the treatment period. RESULTS: After 96 weeks of entecavir therapy in ETV-060, 90% of patients achieved HBV DNA <400 copies/mL as compared to 21% of patients who completed 24 weeks of lamivudine therapy in ETV-047. Increasing proportions of patients achieved ALT normalization and HBeAg seroconversion following long-term entecavir treatment. No patients experienced virologic breakthrough, and substitutions associated with entecavir resistance were not observed in patients with detectable HBV DNA. Entecavir was well tolerated during long-term treatment. CONCLUSIONS: Switching lamivudine-treated patients with chronic hepatitis B to entecavir results in increased virologic suppression with no evidence of resistance through 2 years of entecavir therapy. These findings support recommendations in the current Japanese treatment guidelines that stable lamivudine patients should be switched to entecavir.
PURPOSE: Current Japanese guidelines recommend that patients should be switched from lamivudine to entecavir when they meet certain criteria. This analysis examines the efficacy and safety of long-term entecavir therapy in patients who were switched to entecavir after 24 weeks' lamivudine therapy in Japanese studies ETV-047 and ETV-060. METHODS: The Phase II Japanese study ETV-047 assessed the efficacy of different entecavir doses when compared with lamivudine. A total of 33 Japanese patients who received lamivudine 100 mg daily in ETV-047 entered the open-label rollover study ETV-060 and subsequently received treatment with entecavir 0.5 mg daily. Hepatitis B virus (HBV) DNA suppression, alanine aminotransferase (ALT) normalization, hepatitis B e antigen (HBeAg) seroconversion, and resistance were evaluated among patients with available samples for up to 96 weeks. Safety was assessed throughout the treatment period. RESULTS: After 96 weeks of entecavir therapy in ETV-060, 90% of patients achieved HBV DNA <400 copies/mL as compared to 21% of patients who completed 24 weeks of lamivudine therapy in ETV-047. Increasing proportions of patients achieved ALT normalization and HBeAg seroconversion following long-term entecavir treatment. No patients experienced virologic breakthrough, and substitutions associated with entecavir resistance were not observed in patients with detectable HBV DNA. Entecavir was well tolerated during long-term treatment. CONCLUSIONS: Switching lamivudine-treated patients with chronic hepatitis B to entecavir results in increased virologic suppression with no evidence of resistance through 2 years of entecavir therapy. These findings support recommendations in the current Japanese treatment guidelines that stable lamivudinepatients should be switched to entecavir.
Authors: I Merican; R Guan; D Amarapuka; M J Alexander; A Chutaputti; R N Chien; S S Hasnian; N Leung; L Lesmana; P H Phiet; H M Sjalfoellah Noer; J Sollano; H S Sun; D Z Xu Journal: J Gastroenterol Hepatol Date: 2000-12 Impact factor: 4.029
Authors: J L Dienstag; E R Schiff; T L Wright; R P Perrillo; H W Hann; Z Goodman; L Crowther; L D Condreay; M Woessner; M Rubin; N A Brown Journal: N Engl J Med Date: 1999-10-21 Impact factor: 91.245
Authors: C L Lai; R N Chien; N W Leung; T T Chang; R Guan; D I Tai; K Y Ng; P C Wu; J C Dent; J Barber; S L Stephenson; D F Gray Journal: N Engl J Med Date: 1998-07-09 Impact factor: 91.245
Authors: Marion G Peters; H w Hann Hw; Paul Martin; E Jenny Heathcote; P Buggisch; R Rubin; M Bourliere; K Kowdley; C Trepo; D f Gray Df; M Sullivan; K Kleber; R Ebrahimi; S Xiong; Carol L Brosgart Journal: Gastroenterology Date: 2004-01 Impact factor: 22.682
Authors: Vincent Wai-Sun Wong; Grace Lai-Hung Wong; Chi-Hang Tse; Lilly K W Yuen; Hoi-Yun Chan; Stephen A Locarnini; Henry Lik-Yuen Chan Journal: Dig Dis Sci Date: 2011-07-09 Impact factor: 3.199