Lamivudine therapy in chronic delta hepatitis: a multicentre randomized-controlled pilot study.
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.
Niro
G A
GA
Department of Gastroenterology, Hospital Casa Sollievo della Sofferenza IRCCS, San Giovanni Rotondo, Italy. g.niro@operapadrepio.it
Ciancio
A
A
Tillman
H L
HL
Lagget
M
M
Olivero
A
A
Perri
F
F
Fontana
R
R
Little
N
N
Campbell
F
F
Smedile
A
A
Manns
M P
MP
Andriulli
A
A
Rizzetto
M
M
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*
D000914:Antibodies, Viral; D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine