Randomized controlled trial of adenine arabinoside 5'-monophosphate in chronic active hepatitis B: comparison of the efficacy in heterosexual and homosexual patients.
Twenty-two heterosexuals and 21 homosexuals with chronic active hepatitis B and who had HBsAg, HBeAg and hepatitis B virus DNA in serum were randomized separately to receive adenine arabinoside monophosphate or placebo. In the 10 heterosexuals and nine homosexuals who received placebo, no change in hepatitis B virus DNA level and HBeAg was observed. Among the patients who received adenine arabinoside monophosphate, seven of the 12 heterosexuals and five of the 12 homosexuals lost hepatitis B virus DNA; five heterosexuals and three homosexuals also lost HBeAg; one homosexual lost HBsAg. There was no significant differences in response between heterosexual and homosexual patients. When results were pooled, there was a significant effect of adenine arabinoside monophosphate on hepatitis B virus replication. None of the 19 patients who received placebo but 50% of the 24 patients who received adenine arabinoside monophosphate were negative for serum hepatitis B virus DNA at 10 months after treatment (p less than 0.001) and none of the 19 patients who received placebo and 33% of the 24 patients who received adenine arabinoside monophosphate were negative for HBeAg in serum (p less than 0.005). Retrospective analysis showed that disappearance of hepatitis B virus DNA after administration of adenine arabinoside monophosphate was more common (i) in patients with a low pretreatment hepatitis B virus DNA level than in patients with a high pretreatment hepatitis B virus DNA level (8/11 vs. 4/13, p less than 0.05); (ii) in patients with a high pretreatment ALT level than in patients with a low pretreatment ALT level (10/14 vs. 2/10, p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
Marcellin
P
P
Service d'Hépatologie, Hôpital Beaujon, Clichy, France.
Ouzan
D
D
Degos
F
F
Brechot
C
C
Metman
E H
EH
Degott
C
C
Chevalier
M
M
Berthelot
P
P
Trepo
C
C
Benhamou
J P
JP
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001088:Arabinonucleotides / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D006509:Hepatitis B / Q000188:drug therapy* / Q000276:immunology / Q000382:microbiology; D006511:Hepatitis B Antigens / Q000032:analysis; D006521:Hepatitis, Chronic / Q000188:drug therapy* / Q000276:immunology; D006716:Homosexuality; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D011897:Random Allocation; D001084:Vidarabine Phosphate / Q000627:therapeutic use*
D001088:Arabinonucleotides; D004279:DNA, Viral; D006511:Hepatitis B Antigens; D001084:Vidarabine Phosphate; D000410:Alanine Transaminase