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Biotech / Medical : Biochem Pharma (BCHE)

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To: Jim Oravetz who wrote (626)5/7/1999 6:04:00 AM
From: Harold Engstrom  Read Replies (1) of 783
 
Hepatology 1999 May;29(5):1581-6

Multicenter study of lamivudine therapy for hepatitis B after liver
transplantation.

Perrillo R, Rakela J, Dienstag J, Levy G, Martin P, Wright T, Caldwell S, Schiff E, Gish R, Villeneuve JP, Farr G,
Anschuetz G, Crowther L, Brown N

Section of Gastroenterology, Ochsner Clinic, New Orleans, LA.

[Medline record in process]

Hepatitis B after liver transplantation is often fatal, and no proven medical therapy exists for this condition. We chose to
study the potential efficacy of lamivudine therapy for patients with chronic hepatitis B after liver transplantation. Fifty-two
patients with chronic hepatitis B after liver transplantation were treated in an open label, multicenter study. Each had
detectable hepatitis B virus (HBV) DNA in serum and 45 (87%) had detectable serum hepatitis B e antigen before treatment.
Patients were treated for 52 weeks with lamivudine (100 mg daily). The primary endpoint was undetectability of HBV DNA;
secondary endpoints included normalization of serum alanine transaminase (ALT) levels, disappearance of hepatitis B e
antigen, and improvement in liver histology. After treatment, 60% of patients had undetectable HBV DNA by solution
hybridization assay, 14 (31%) of the initially positive patients lost hepatitis B e antigen; hepatitis B surface antigen was
undetectable in 3 (6%); and serum ALT levels normalized in 71%. Blinded histological assessments showed improvement in
the histological activity index (P =.007 for periportal necrosis,.001 for lobular necrosis, and.013 for portal inflammation).
YMDD variants of HBV, potentially associated with drug resistance, were detected in 14 (27%) of the patients. Repeat liver
biopsies in 7 patients with the mutated virus were unchanged in 2, improved in 2, and worse in 3. We conclude that
lamivudine is a potentially effective therapy for hepatitis B after liver transplantation.
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