title: Lamivudine therapy in chronic delta hepatitis: a multicentre randomized-controlled pilot study.
abstract: BACKGROUND
  Delta virus (HDV)-related chronic hepatitis is difficult to treat.
  
  
  OBJECTIVE
  To evaluate the efficacy of lamivudine 100 mg daily on serum HDV-RNA, hepatitis D virus antibodies and alanine aminotransferase levels, liver histology, and on hepatitis B surface antigen seroconversion.
  
  
  METHODS
  Thirty-one hepatitis B surface antigen-positive, HDV-RNA-positive patients with ALT > or = 1.5 upper normal level and compensated liver disease were randomized (1:2 ratio) to placebo (group A, n = 11) or lamivudine (group B, n = 20) for 52 weeks; thereafter, all patients were given lamivudine for 52 weeks and followed up for 16 weeks.
  
  
  RESULTS
  Twenty-five patients (81%) completed the study. No patient was HDV-RNA-negative at week 52; three patients (11%) were negative at week 104. Two of them remained HDV-RNA-negative at week 120, and one lost the hepatitis B surface antigen without seroconversion. Paired pre-treatment and week 104 liver biopsies were available from 19 patients: of which three of seven (43%) from group A and two of 12 patients (17%) from group B had a > or =2 point decrease in the Ishak necroinflammatory score.
  
  
  CONCLUSIONS
  A sustained complete response was achieved in 8% of hepatitis D virus-infected patients treated with lamivudine and a partial histological response in 26% of them. Hepatitis D virus viraemia was unaffected, even in patients when hepatitis B virus replication was lowered by lamivudine therapy.
authors.affiliation: Department of Gastroenterology, Hospital Casa Sollievo della Sofferenza IRCCS, San Giovanni Rotondo, Italy. g.niro@operapadrepio.it
authors.forename: G A
authors.initials: GA
authors.lastname: Niro
authors.forename: A
authors.initials: A
authors.lastname: Ciancio
authors.forename: H L
authors.initials: HL
authors.lastname: Tillman
authors.forename: M
authors.initials: M
authors.lastname: Lagget
authors.forename: A
authors.initials: A
authors.lastname: Olivero
authors.forename: F
authors.initials: F
authors.lastname: Perri
authors.forename: R
authors.initials: R
authors.lastname: Fontana
authors.forename: N
authors.initials: N
authors.lastname: Little
authors.forename: F
authors.initials: F
authors.lastname: Campbell
authors.forename: A
authors.initials: A
authors.lastname: Smedile
authors.forename: M P
authors.initials: MP
authors.lastname: Manns
authors.forename: A
authors.initials: A
authors.lastname: Andriulli
authors.forename: M
authors.initials: M
authors.lastname: Rizzetto
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000097:blood; D019701:Hepatitis D, Chronic / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D003698:Hepatitis Delta Virus / Q000276:immunology / Q000302:isolation & purification; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*
chemical_list: D000914:Antibodies, Viral; D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine