title: Efficacy of tenofovir in patients with Lamivudine failure is not different from that in nucleoside/nucleotide analogue-naive patients with chronic hepatitis B.
abstract: 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: Department of Gastroenterohepatology, Istanbul University, Istanbul Faculty of Medicine, Capa, Istanbul, Turkey.
authors: Bulent
authors: B
authors: Baran
authors: Ozlem Mutluay
authors: OM
authors: Soyer
authors: Asli Cifcibasi
authors: AC
authors: Ormeci
authors: Suut
authors: S
authors: Gokturk
authors: Sami
authors: S
authors: Evirgen
authors: Hamza Ugur
authors: HU
authors: Bozbey
authors: Filiz
authors: F
authors: Akyuz
authors: Cetin
authors: C
authors: Karaca
authors: Kadir
authors: K
authors: Demir
authors: Fatih
authors: F
authors: Besisik
authors: Derya
authors: D
authors: Onel
authors: Mine
authors: M
authors: Gulluoglu
authors: Selim
authors: S
authors: Badur
authors: Sabahattin
authors: S
authors: Kaymakoglu
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D005260:Female; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009705:Nucleosides / Q000627:therapeutic use*; D009711:Nucleotides / Q000627:therapeutic use*; D063065:Organophosphonates / Q000627:therapeutic use*; D012189:Retrospective Studies; D000068698:Tenofovir
chemical_list: D019380:Anti-HIV Agents; D009705:Nucleosides; D009711:Nucleotides; D063065:Organophosphonates; D019259:Lamivudine; D000068698:Tenofovir; D000225:Adenine
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