Adefovir dipivoxil added to ongoing lamivudine therapy in patients with lamivudine-resistant hepatitis B e antigen-negative chronic hepatitis B

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Aliment Pharmacol Ther. 2005 Mar 1;21(5):531-7.

Adefovir dipivoxil added to ongoing lamivudine therapy in patients with

lamivudine-resistant hepatitis B e antigen-negative chronic hepatitis B.

Vassiliadis T, Nikolaidis N, Giouleme O, Tziomalos K, Grammatikos N,

Patsiaoura K, Zezos P, Gkisakis D, Theodoropoulos K, Katsinelos P,

Orfanou-Koumerkeridou E, Eugenidis N.

2nd Propaedeutic Department of Internal Medicine, Aristotle University of

Thessaloniki, Hippokration General Hospital, Thessaloniki, Greece.

Summary Background : Long-term treatment with lamivudine is required to

control viral replication in patients with hepatitis B e antigen-negative

chronic hepatitis B, but is associated with a high rate of viral resistance.

The role of adefovir dipivoxil in these patients has not been definitively

evaluated. Aim : To address the role of adefovir in the management of

patients with lamivudine-resistant hepatitis B e antigen-negative chronic

hepatitis B. Methods : Patients were assigned to receive adefovir 10 mg once

daily plus ongoing lamivudine 100 mg once daily for 52 weeks. The primary

end point was reduction in serum hepatitis B virus DNA level (hepatitis B

virus DNA response). Secondary end points included the proportion of

patients with undetectable hepatitis B virus DNA at week 52 (complete

virological response) and the percentage of patients with normalization of

alanine transferase level at week 52 (biochemical response). Results : A

total of 49 consecutive patients were enrolled in this study. After 52 weeks

of treatment, all patients had an hepatitis B virus DNA response and 57.1%

had complete virological response. Biochemical response occurred in 75.6% of

patients. Conclusions : Administration of adefovir in patients with

lamivudine-resistant chronic hepatitis B results in significant suppression

of viral replication. Nevertheless, continuous therapy will probably be

needed in order to maintain remission in these patients.

PMID: 15740536 [PubMed - in process]