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Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues†
Article first published online: 25 AUG 2009
Copyright © 2009 American Association for the Study of Liver Diseases
Volume 51, Issue 1, pages 73–80, January 2010
How to Cite
van Bömmel, F., de Man, R. A., Wedemeyer, H., Deterding, K., Petersen, J., Buggisch, P., Erhardt, A., Hüppe, D., Stein, K., Trojan, J., Sarrazin, C., Böcher, W. O., Spengler, U., Wasmuth, H. E., Reinders, J. G.P., Möller, B., Rhode, P., Feucht, H.-H., Wiedenmann, B. and Berg, T. (2010), Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues. Hepatology, 51: 73–80. doi: 10.1002/hep.23246
Potential conflict of interest: Dr. van Bömmel received grants from Gilead. Dr. Buggisch is on the speakers' bureau of Gilead. Dr. Sarrazin is a consultant for and is on the speakers' bureau of Gilead and Bristol-Myers Squibb. Dr. Berg is a consultant for, advises, is on the speakers' bureau of, and received grants from Gilead.
- Issue published online: 23 DEC 2009
- Article first published online: 25 AUG 2009
- Accepted manuscript online: 25 AUG 2009 12:00AM EST
- Manuscript Accepted: 11 AUG 2009
- Manuscript Received: 10 FEB 2009
- German Network of Excellence (HEPNET; BMBF). Grant Number: 01 KI 0437
- European Vigilance Network excellence combating viral resistance (VIRGIL). Grant Number: LSHM-CT-2004-503359
- Gilead Sciences Inc.
Tenofovir disoproxil fumarate (TDF) has demonstrated high antiviral efficacy in treatment-naive patients with chronic hepatitis B virus (HBV) infection but experience in nucleoside/nucleotide analogue (NA)-experienced patients is limited. In this retrospective multicenter study we therefore assessed the long-term efficacy of TDF monotherapy in patients with prior failure or resistance to different NA treatments. Criteria for inclusion were HBV DNA levels >4.0 log10 copies/mL at the start and a minimum period of TDF therapy for at least 6 months. In all, 131 patients (mean age 42 ± 12 years, 95 male, 65% hepatitis B e antigen [HBeAg]-positive) were eligible. Pretreatment consisted of either monotherapy with lamivudine (LAM; n = 18), adefovir (ADV; n = 8), and sequential LAM-ADV therapy (n = 73), or add-on combination therapy with both drugs (n = 29). Three patients had failed entecavir therapy. Resistance analysis in 113 of the 131 patients revealed genotypic LAM and ADV resistance in 62% and 19% of patients, respectively. The mean HBV DNA level at TDF baseline was 7.6 ± 1.5 log10 copies/mL. The overall cumulative proportion of patients achieving HBV DNA levels <400 copies/mL was 79% after a mean treatment duration of 23 months (range, 6–60). Although LAM resistance did not influence the antiviral efficacy of TDF, the presence of ADV resistance impaired TDF efficacy (100% versus 52% probability of HBV DNA <400 copies/mL, respectively). However, virologic breakthrough was not observed in any of the patients during the entire observation period. Loss of HBeAg occurred in 24% of patients and HBsAg loss occurred in 3%. No significant adverse events were noticed during TDF monotherapy. Conclusion: TDF monotherapy induced a potent and long-lasting antiviral response in NA-experienced patients with previous treatment failure. Our data may have implications for current add-on strategies. (HEPATOLOGY 2009.)