Potential conflict of interest: Nothing to report.
Virological breakthrough and resistance in patients with chronic hepatitis B receiving nucleos(t)ide analogues in clinical practice†
Article first published online: 25 AUG 2011
Copyright © 2011 American Association for the Study of Liver Diseases
Volume 54, Issue 3, pages 1104–1105, 2 September 2011
How to Cite
Ridruejo, E., Adrover, R. and Silva, M. O. (2011), Virological breakthrough and resistance in patients with chronic hepatitis B receiving nucleos(t)ide analogues in clinical practice. Hepatology, 54: 1104–1105. doi: 10.1002/hep.24498
- Issue published online: 25 AUG 2011
- Article first published online: 25 AUG 2011
- Accepted manuscript online: 30 JUN 2011 07:11PM EST
- Manuscript Accepted: 7 JUN 2011
To the Editor:
We read with interest the article by Hongthanakorn et al. published in a recent issue of HEPATOLOGY.1 The authors reported a very high incidence of virological breakthrough (VBT) in patients receiving five different nucleos(t)ide analogues (NUCs) in clinical practice: 26% (39 patients). They reported that 7% of NUC-naïve patients receiving entecavir (ETV) experienced VBT, and that the cumulative probability of experiencing VBT at 3 years was 13%.
The VBT rates reported by Hongthanakorn et al. are higher than described previously. In our population of 69 NUC-naïve chronic HBV patients treated in routine clinical practice with ETV, we found that 100% achieved undetectable HBV DNA after 96 weeks of treatment.2 We did not perform tests to evaluate genetic resistance, but we found no evidence of clinical resistance to treatment or VBT. Other studies in clinical practice have shown high efficacy of treatment with low rates of VBT, around 1%.3-5 In phase 3 randomized clinical trials, VBT rates with ETV treatment were 1.6%.6, 7
Hongthanakorn et al. argue that “medication adherence is likely to be lower in clinical practice than in phase 3 clinical trials, where highly motivated patients are recruited and closely monitored” and that “patients with CHB receiving NUC therapy who experienced VBT should be counseled on medication adherence.”1 We agree that adherence is crucial in the efficacy of treatment, but we have demonstrated that a high adherence rate and treatment efficacy can be obtained in clinical practice.
- 1Virological breakthrough and resistance in patients with chronic hepatitis B receiving nucleos(t)ide analogues in clinical practice. HEPATOLOGY 2011; 53: 1854-1863., , , , , , .
- 2Effectiveness of entecavir in chronic hepatitis B NUC naive patients in routine clinical practice. Int J Clin Pract. In press., , , , , , et al.
- 3Effectiveness of entecavir for NUC-naive, HBeAg-negative chronic hepatitis B patients in clinical practice: a 2-year multicenter cohort study in 311 patients. J Hepatol 2010; 52( Suppl. 1): S389., , , , , , et al.
- 4Maintained long-term suppression of HBV replication in NUC-naïve patients with chronic hepatitis B treated with ETV monotherapy in field practice: the Italian multicenter experience. HEPATOLOGY 2010; 52( Suppl. 1): S514A., , , , , , et al.
- 5Outcomes of treatment for chronic hepatitis B with entecavir therapy. HEPATOLOGY 2010; 52( Suppl. 1): S537A., , , , , , et al.
- 6Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2006; 354: 1011-1020., , , , , , et al.
- 7A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006; 354: 1001-1010., , , , , , et al.
Ezequiel Ridruejo* , Raúl Adrover, Marcelo O. Silva, * Hepatology Section, Department of Medicine, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno, Buenos Aires, Argentina, Centro de Hepatología, Buenos Aires, Argentina, Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Buenos Aires, Argentina.