Document Detail


Efficacy of tenofovir in patients with Lamivudine failure is not different from that in nucleoside/nucleotide analogue-naive patients with chronic hepatitis B.
MedLine Citation:
PMID:  23380725     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
We evaluated the efficacy of tenofovir disoproxil fumarate (TDF) in patients with lamivudine failure (LAM-F) in comparison with that in nucleoside/nucleotide analogue (NA)-naïve patients with chronic hepatitis B (CHB). The criteria for inclusion were being NA naïve or having previous LAM-F and receiving TDF therapy for at least 6 months. Biochemical and virological tests were performed at the baseline, at 3-month intervals in the first year, and every 6 months thereafter. The primary outcome measure for efficacy was a complete virological response (CVR), defined as an HBV DNA level of <20 IU/ml. CVR rates were calculated by Kaplan-Meier analysis, and a multivariate Cox proportional-hazard model was generated in order to find predictive factors independently associated with the time to a CVR. We included 197 patients in the study (136 males; mean age, 43 ± 12 years; 105 patients were NA naïve). Sixty-five patients had hepatitis B e antigen (HBeAg)-positive CHB. The median duration of TDF treatment was 29 (range, 6 to 52) months. Seventy-one patients (77%) in the LAM-F group were treated with TDF add-on therapy. The CVR rates of the NA-naïve and LAM-F groups were comparable in HBeAg-negative (94% versus 96% at month 36, P = 0.10) and HBeAg-positive patients (67% versus 83% at month 36, P = 0.48). According to the multivariate Cox regression model, only HBeAg positivity (hazard ratio [HR], 0.39; 95% confidence interval [CI], 0.26 to 0.59; P < 0.001) and a high baseline HBV DNA level (HR, 0.44; 95% CI, 0.29 to 0.67; P < 0.001) had a significant influence on the time to a CVR. The similar cumulative CVR rates during the follow-up show that TDF has comparable efficacy in lamivudine-experienced and NA-naïve patients, and the presence of resistance mutations did not alter the response rates.
Authors:
Bulent Baran; Ozlem Mutluay Soyer; Asli Cifcibasi Ormeci; Suut Gokturk; Sami Evirgen; Hamza Ugur Bozbey; Filiz Akyuz; Cetin Karaca; Kadir Demir; Fatih Besisik; Derya Onel; Mine Gulluoglu; Selim Badur; Sabahattin Kaymakoglu
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Publication Detail:
Type:  Journal Article     Date:  2013-02-04
Journal Detail:
Title:  Antimicrobial agents and chemotherapy     Volume:  57     ISSN:  1098-6596     ISO Abbreviation:  Antimicrob. Agents Chemother.     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-03-15     Completed Date:  2013-09-06     Revised Date:  2013-10-08    
Medline Journal Info:
Nlm Unique ID:  0315061     Medline TA:  Antimicrob Agents Chemother     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1790-6     Citation Subset:  IM    
Affiliation:
Department of Gastroenterohepatology, Istanbul University, Istanbul Faculty of Medicine, Capa, Istanbul, Turkey.
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MeSH Terms
Descriptor/Qualifier:
Adenine / analogs & derivatives*,  therapeutic use
Adult
Anti-HIV Agents / therapeutic use
Female
Hepatitis B, Chronic / drug therapy*
Humans
Lamivudine / therapeutic use*
Male
Middle Aged
Nucleosides / therapeutic use*
Nucleotides / therapeutic use*
Organophosphonates / therapeutic use*
Retrospective Studies
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Nucleosides; 0/Nucleotides; 0/Organophosphonates; 0/tenofovir disoproxil; 134678-17-4/Lamivudine; 73-24-5/Adenine
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