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

Abstract

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 > 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.

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.

• Authors: 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
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 22 Issue 3 Pg. 227-32 (Aug 01 2005) ISSN: 0269-2813 [Print] England
• PMID: 16091060 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antibodies, Viral
• Antiviral Agents
• Hepatitis B Surface Antigens
• RNA, Viral
• Reverse Transcriptase Inhibitors
• Lamivudine

Topics

• Adult
• Antibodies, Viral (blood)
• Antiviral Agents (therapeutic use)
• Double-Blind Method
• Female
• Hepatitis B Surface Antigens (blood)
• Hepatitis D, Chronic (drug therapy, pathology, virology)
• Hepatitis Delta Virus (immunology, isolation & purification)
• Humans
• Lamivudine (therapeutic use)
• Male
• Middle Aged
• RNA, Viral (blood)
• Reverse Transcriptase Inhibitors (therapeutic use)