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Entecavir 96 Weeks in Lamivudine-Refractory HBeAg(+): efficacy, safety, resistance
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Reported by Jules Levin
DDW, May 21-25, 2006 Los Angeles
"Entecavir Results in Continued Virologic & Biochemical Improvement and HBeAg Seroconversion through 96 weeks of treatment in lamivudine-Refractory, HBeAg(+) Chronic Hepatitis B patients (ETV-026)"
M Sherman1, P Martin2, W Lee3, C Yurdaydin4, J Sollano5, J Vaughn6, RG Hindes6
1Dept of Medicine, University Health Network, Toronto, Canada
2Division of Liver Diseases, Mount Sinai School of Medicine, New York, NY, USA
3Dept of Internal Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, USA
4Dept of Gastroenterology and the Hepatology Institute, University of Ankara Medical School, Ankara, Turkey
5Dept of Medicine, University of Santo Tomas, Manila, Phillipines
6Bristol-Myers Squibb Company, Wallingford, CT, USA
Author Summary
Continued ETV therapy in the Year 2 treatment cohort provided additional clinical benefit.
Cumulative confirmed results in ETV patients:
- 30% undetectable HBV DNA (<30 copies/ml)
- 85% normalized ALT
- 17% HBe seroconversion on- and off-treatment (120 weeks)
As presented elsewhere, 6% of patients had evidence of pre-existing resistance substitutions at baseline, with virologic rebounds due to resistance observed in 1% and 9% of patients by week 48 and week 96, respectively.
Study Design Through Week 48
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