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

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...

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Bibliographic Details
Published in:	Hepatology (Baltimore, Md.) Vol. 34; no. 3; pp. 578 - 582
Main Authors:	de Man, Robert A., Wolters, Leonieke M.M., Nevens, Frederik, Chua, David, Sherman, Morris, Lai, Cing L., Gadano, Adrian, Lee, Youngmee, Mazzotta, Fransesco, Thomas, Neil, DeHertogh, Deborah
Format:	Journal Article
Language:	English
Published:	Philadelphia, PA Elsevier Inc 01-09-2001 W.B. Saunders Wiley
Subjects:	Administration, Oral Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Antiviral Agents - administration & dosage Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Biological and medical sciences DNA, Viral - analysis Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Guanine - administration & dosage Guanine - adverse effects Guanine - analogs & derivatives Guanine - therapeutic use Hepatitis B virus - genetics Hepatitis B, Chronic - drug therapy Hepatitis B, Chronic - virology Humans Liver - enzymology Medical sciences Pharmacology. Drug treatments Safety Transaminases - metabolism Infection Human Viral hepatitis B Chemotherapy Chronic Viral disease Oral administration Entecavir Digestive diseases Hepatic disease Antiviral
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Summary:	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 < .05). All doses of entecavir were well tolerated with no significant difference between treated patients and those receiving placebo. No significant changes in alanine transaminase (ALT) levels within the dose groups and the placebo group between baseline and the end of treatment were observed. Three patients (9%) (1 each in the 0.05-, 0.1-, and 0.5-mg groups) experienced asymptomatic hepatitis flares 16 weeks (2 patients) and 24 weeks (1 patient) after withdrawal of entecavir. In conclusion, in this 28-day study of entecavir a pronounced decrease of HBV DNA was observed and there were no significant side effects in entecavir patients in comparison with placebo-treated patients. (HEPATOLOGY 2001;34:578-582.)
ISSN:	0270-9139 1527-3350
DOI:	10.1053/jhep.2001.26815