Document Detail

Adefovir dipivoxil alone or in combination with lamivudine for three months in patients with lamivudine resistant compensated chronic hepatitis B.
MedLine Citation:
PMID:  17431777     Owner:  NLM     Status:  MEDLINE    
We studied clinical and laboratory effects of 3 months of lamivudine with adefovir combination and adefovir dipivoxil (AD) alone in the treatment of patients with lamivudine-resistant hepatitis B virus (HBV) infection. Eligible patients were hepatitis B surface antigen-positive men and women with compensated liver disease who were given lamivudine at least more than 6 months and had HBV polymerase gene mutation. Patients were assigned to receive adefovir 10 mg/day (Group 1) or adefovir 10 mg once daily and lamivudine 100 mg once daily combination during first 3 months, and then stopped lamivudine and continued adefovir (Group 2). Median age was 48 years (34 males and 20 females, and 35 were HBeAg-negative). Baseline median ALT, AST, and HBV DNA levels were 66 IU/l, 49 IU/l, and 6.7 log(10) copy/ml, respectively. Median adefovir therapy time and ALT normalization time were 9 and 3.5 months, respectively. There was no significant difference between groups according to the baseline HBV DNA, ALT, HBe Ag status, age, gender, and lamivudine resistance time. Virological and biochemical responses were similar in both groups during therapy. Two patients (8%) had ALT flare more than five times upper limit of normal without any clinical decompensation in Group 1. Mild ALT elevation according to baseline levels were found in 8 (27.6%) and 4 (17.4%) patients, respectively, in Group 2 and Group 1, and no statistically significance between two groups. In conclusion, this study showed that it is not necessary to continue lamivudine therapy while switching to AD therapy. Adefovir alone is effective in the treatment of patients with lamivudine resistant HBV infection and compensated liver disease, without significant clinical and laboratory flares. However, it is not easy to say that switching to AD with cessation of lamivudine is safe, because the study population is not enough for precise conclusion and resistance may be a considerable problem against AD in patients using long-term treatment.
Murat Akyildiz; Fulya Gunsar; Galip Ersoz; Zeki Karasu; Tankut Ilter; Yucel Batur; Ulus Akarca
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2007-04-12
Journal Detail:
Title:  Digestive diseases and sciences     Volume:  52     ISSN:  0163-2116     ISO Abbreviation:  Dig. Dis. Sci.     Publication Date:  2007 Dec 
Date Detail:
Created Date:  2007-11-08     Completed Date:  2007-12-20     Revised Date:  2013-05-24    
Medline Journal Info:
Nlm Unique ID:  7902782     Medline TA:  Dig Dis Sci     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3444-7     Citation Subset:  AIM; IM    
Department of Gastroenterology, Ege University Medical School, Bornova, Izmir, Turkey.
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MeSH Terms
Adenine / analogs & derivatives*,  therapeutic use
Alanine Transaminase / blood
DNA, Viral / genetics*
Drug Resistance, Viral*
Drug Therapy, Combination
Follow-Up Studies
Hepatitis B e Antigens / immunology
Hepatitis B virus / genetics*,  immunology
Hepatitis B, Chronic / drug therapy*,  enzymology,  virology
Lamivudine / therapeutic use*
Middle Aged
Mutation / drug effects
Organophosphonates / therapeutic use*
Polymerase Chain Reaction
Retrospective Studies
Reverse Transcriptase Inhibitors / therapeutic use*
Treatment Outcome
Reg. No./Substance:
0/DNA, Viral; 0/Hepatitis B e Antigens; 0/Organophosphonates; 0/Reverse Transcriptase Inhibitors; 134678-17-4/Lamivudine; 73-24-5/Adenine; EC Transaminase; U6Q8Z01514/adefovir dipivoxil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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