Lamivudine therapy in chronic delta hepatitis: A multicentre randomized-controlled pilot study

G. A. Niro, A. Ciancio, H. L. Tillman, M. Lagget, A. Olivero, F. Perri, R. Fontana, N. Little, F. Campbell, A. Smedile, M. P. Manns, A. Andriulli, M. Rizzetto

Research output: Contribution to journalArticlepeer-review


Background: Delta virus (HDV)-related chronic hepatitis is difficult to treat. Aims: 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 sero-conversion. Methods: Thirty-one hepatitis B surface antigen-positive, HDV-RNA-positive patients with ALT > 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 >2 point decrease in the Ishak necroinflammatory score. Conclusion: 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.

Original languageEnglish
Pages (from-to)227-232
Number of pages6
JournalAlimentary Pharmacology and Therapeutics
Issue number3
Publication statusPublished - Aug 1 2005

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)


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