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EFFICACY OF TENOFOVIR IN PATIENTS WITH LAMIVUDINE FAILURE IS NOT DIFFERENT FROM NUCLEOS(T)IDE ANALOGUE NAIVE PATIENTS WITH CHRONIC HEPATITIS B.
MedLine Citation:
PMID:  23380725     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Background/Aims: To evaluate the efficacy of tenofovir disoproxil fumarate (TDF) in patients with lamivudine failure (LAM-F) in comparison to nucleos(t)ide analogue (NA) naïve patients with chronic hepatitis B (CHB).Methods: Criteria for inclusion were being NA-naÏve or previous LAM-F and receiving TDF therapy for at least 6 months. Biochemical and virological tests were obtained at baseline and 3-month intervals in the first year and every 6 months thereafter. The primary outcome measure for efficacy was complete virological response (CVR), defined as HBV-DNA<20 IU/ml. CVR rates were calculated by Kaplan-Meier analysis and a multivariate Cox proportional hazard model was generated in order to find out predictive factors independently associated with time to CVR.Results: 197 patients (136 male, mean age 43±12, 105 patients were NA-naive) were included in the study. Sixty-five patients had HBeAg-positive CHB. Median duration of TDF treatment was 29 months (6-52). Seventy-one patients (77%) in the LAM-F group were treated with TDF add-on therapy. CVR rates in NA-naÏve and LAM-F groups were comparable in HBeAg-negative (94% vs. 96% at 36(th) month, p=0.10) and HBeAg-positive patients (67% vs. 83% at 36(th) month, p=0.48). According to multivariate Cox regression model only HBeAg positivity (HR: 0.39, 95%CI 0.26-0.59, p<0.001) and high baseline HBV-DNA level (HR: 0.44, 95%CI 0.29-0.67, p<0.001) had significant influence on time to CVR.Conclusions: The similar cumulative CVR rates during the follow-up shows that TDF has a 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:  2013-2-4
Journal Detail:
Title:  Antimicrobial agents and chemotherapy     Volume:  -     ISSN:  1098-6596     ISO Abbreviation:  Antimicrob. Agents Chemother.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-2-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0315061     Medline TA:  Antimicrob Agents Chemother     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Istanbul University, Istanbul Faculty of Medicine, Department of Gastroenterohepatology.
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