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Entecavir for Treatment of Lamivudine-Refractory, HBeAg-Positive Chronic Hepatitis B.
- Source :
- Gastroenterology (00165085); Jun2006, Vol. 130 Issue 7, p2039-2049, 11p
- Publication Year :
- 2006
-
Abstract
- Background & Aims: Lamivudine treatment is associated with frequent development of resistant hepatitis B virus (HBV) and loss of treatment benefit. In preclinical and phase II studies, entecavir demonstrated potent antiviral activity against lamivudine-resistant HBV. Methods: In this phase III, double-blind trial, hepatitis B e antigen-positive patients who were refractory to lamivudine therapy (persistent viremia or documented YMDD mutations while receiving lamivudine) were randomized to switch to entecavir 1 mg daily (n = 141) or continue lamivudine 100 mg daily (n = 145) for a minimum of 52 weeks. Two coprimary end points were assessed at 48 weeks: histologic improvement and a composite end point (HBV branched DNA <0.7 MEq/mL and alanine aminotransferase [ALT] <1.25 times the upper limit of normal). Results: Histologic improvement occurred in 55% (68/124) of entecavir-treated vs 28% (32/116) of lamivudine-treated patients (P < .0001). More patients on entecavir than lamivudine achieved the composite end point: 55% (77/141) vs 4% (6/145), respectively (P < .0001). Mean change from baseline in HBV DNA was −5.11 log<subscript>10</subscript> copies/mL for entecavir-treated patients and −0.48 log<subscript>10</subscript> copies/mL for lamivudine-treated patients (P < .0001). Virologic rebound because of entecavir resistance substitutions occurred in 2 of 141 of entecavir-treated patients, and genotypic evidence of resistance was detected in 10 patients. The safety profile of entecavir was comparable to lamivudine with fewer ALT flares on treatment. Conclusions: In patients with lamivudine-refractory chronic hepatitis B, switching to entecavir provides superior histologic improvement, viral load reduction, and ALT normalization compared with continuing lamivudine, with a comparable adverse event profile. [Copyright &y& Elsevier]
- Subjects :
- HEPATITIS B
LIVER diseases
AMINOTRANSFERASES
GENES
Subjects
Details
- Language :
- English
- ISSN :
- 00165085
- Volume :
- 130
- Issue :
- 7
- Database :
- Supplemental Index
- Journal :
- Gastroenterology (00165085)
- Publication Type :
- Academic Journal
- Accession number :
- 21623117
- Full Text :
- https://doi.org/10.1053/j.gastro.2006.04.007