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

Summary 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.