title: Clinical and virological response to adefovir dipovixil for lamivudine-resistant HBeAg-negative hepatitis B.
abstract: Adefovir dipivoxil (ADV), a new nucleotide analogue, has demonstrated activity against lamivudine-resistant HBV both in vivo and in vitro. Herein, we present eight lamivudine-resistant patients with chronic anti-HBe positive hepatitis B treated orally with adefovir dipivoxil at 10 mg/die to evaluate the efficacy and safety of this drug and to determine the possible development of clinical ADV resistance. After 48 weeks of therapy, 4/8 (50%) patients demonstrated a complete response with normalization of alaninoaminotransferase levels (ALT, normal value < 40 IU/L) and undetectable serum HBV- DNA (< 100 copies/ml tested by a PCR assay). In 3/8 subjects (37.5%), we observed a partial response with a > 50% reduction of both ALT and HBV DNA levels. Only one patient did not respond. Adefovir was well-tolerated and no patient presented adverse events related to treatment; there were no changes in renal parameters. We conclude that in patients with anti-HBe positive chronic hepatitis B resistant to lamivudine, a 48-week ADV treatment resulted in significant biochemical and virological improvement without major adverse effects.
authors.affiliation: Clinic of Infectious Diseases, University of Foggia, Italy. g.scotto@medicina.unifg.it
authors.forename: Gaetano
authors.initials: G
authors.lastname: Scotto
authors.forename: Emilio
authors.initials: E
authors.lastname: Palumbo
authors.forename: Vincenzina
authors.initials: V
authors.lastname: Fazio
authors.forename: Alessandra
authors.initials: A
authors.lastname: Tartaglia
authors.forename: Annalisa
authors.initials: A
authors.lastname: Saracino
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Angarano
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000284:Administration, Oral; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D014766:Viremia / Q000188:drug therapy / Q000821:virology
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006513:Hepatitis B e Antigens; D063065:Organophosphonates; D019259:Lamivudine; D000410:Alanine Transaminase; D000225:Adenine; C106812:adefovir dipivoxil