Lamivudine therapy in chronic delta hepatitis: a multicentre randomized-controlled pilot study
Article first published online: 21 JUL 2005
Alimentary Pharmacology & Therapeutics
Volume 22, Issue 3, pages 227–232, August 2005
How to Cite
NIRO, G. A., CIANCIO, A., TILLMAN, H. L., LAGGET, M., OLIVERO, A., PERRI, F., FONTANA, R., LITTLE, N., CAMPBELL, F., SMEDILE, A., MANNS, M. P., ANDRIULLI, A. and RIZZETTO, M. (2005), Lamivudine therapy in chronic delta hepatitis: a multicentre randomized-controlled pilot study. Alimentary Pharmacology & Therapeutics, 22: 227–232. doi: 10.1111/j.1365-2036.2005.02542.x
- Issue published online: 21 JUL 2005
- Article first published online: 21 JUL 2005
- Accepted for publication 17 May 2005
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 seroconversion.
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.