Entecavir versus Lamivudine for Patients with HBeAg-Negative Chronic Hepatitis B

摘要: BACKGROUND Entecavir is a potent and selective antiviral agent that has demonstrated efficacy in phase 2 studies patients with hepatitis B e antigen (HBeAg)–negative chronic B. METHODS In this 3, double-blind trial, we randomly assigned 648 HBeAgnegative who had not previously been treated nucleoside analogue to receive 0.5 mg of entecavir or 100 lamivudine once daily for minimum 52 weeks. The primary end point was histologic improvement (a decrease by at least two points the Knodell necroinflammatory score, without worsening fibrosis). RESULTS Histologic after 48 weeks treatment occurred 208 296 group adequate baseline liver-biopsy specimens could be evaluated (70 percent), as compared 174 287 such (61 percent, P = 0.01). More than undetectable serum virus (HBV) DNA levels according polymerase-chain-reaction assay (90 percent vs. 72 P<0.001) normalization alanine aminotransferase (78 71 0.045). mean reduction HBV from week greater (5.0 4.5 log [on base-10 scale] copies per milliliter, P<0.001). There no evidence resistance entecavir. Safety adverse-event profiles were similar groups. CONCLUSIONS Among HBeAg-negative analogue, rates improvement, virologic response, significantly higher lamivudine. safety profile agents similar, there viral (ClinicalTrials.gov number, NCT00035789.)