Efficacy of Tenofovir in Patients with Lamivudine Failure Is Not Different from That in Nucleoside/Nucleotide Analogue-Naive Patients with Chronic Hepatitis B
Date
2013Author
Gokturk, Suut
Baran, Bulent
Gulluoglu, Mine
Ormeci, Asli Cifcibasi
Evirgen, Sami
Akyuz, Filiz
Kaymakoglu, Sabahattin
Soyer, Ozlem Mutluay
Demir, Kadir
Bozbey, Hamza Ugur
Onel, Derya
Karaca, Cetin
Besisik, Fatih
Badur, Selim
Metadata
Show full item recordAbstract
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)-naive patients with chronic hepatitis B (CHB). The criteria for inclusion were being NA naive 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 naive). 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-naive 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-naive patients, and the presence of resistance mutations did not alter the response rates.
URI
http://hdl.handle.net/20.500.12627/136930https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84875189825&origin=inward
https://doi.org/10.1128/aac.02600-12
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