Safety and efficacy of oral entecavir given for 28 days in patients with chronic hepatitis B virus infection

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Abstract

Entecavir is an oral antiviral drug with selective activity against hepatitis B virus (HBV). We conducted a randomized, placebo-controlled, dose-escalating study in patients with chronic hepatitis B infection in which we evaluated the efficacy and safety of entecavir given for 28 days. Follow-up was 24 weeks. All doses of entecavir (0.05 mg, 0.1 mg, 0.5 mg, and 1.0 mg) showed a pronounced suppression of replication of the HBV with a 2.21, 2.29, 2.81, and 2.55 mean log10 reduction of viral load, respectively. Approximately 25% of patients on entecavir showed a decline of HBV DNA below the limit of detection of the Chiron HBV-DNA assay (<0.7 MEq/mL). In the postdosing follow-up period patients who were treated with 0.5 and 1.0 mg of entecavir showed a considerably slower return in their HBV DNA levels to baseline compared with those patients treated with lower dosages (P

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de Man, R. A., Wolters, L. M. M., Nevens, F., Chua, D., Sherman, M., Lai, C. L., … DeHertogh, D. (2001). Safety and efficacy of oral entecavir given for 28 days in patients with chronic hepatitis B virus infection. Hepatology, 34(3), 578–582. https://doi.org/10.1053/jhep.2001.26815

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