No detectable resistance to tenofovir disoproxil fumarate in HBeAg+ and HBeAg− patients with chronic hepatitis B after 8 years of treatment

Summary A major hurdle in the long‐term treatment of chronic hepatitis B (CHB) patients is to maintain viral suppression in the absence of drug resistance. To date, no evidence of resistance to tenofovir disoproxil fumarate (TDF) has been observed. A cumulative evaluation of CHB patients who qualifi...

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Bibliographic Details
Published in:Journal of viral hepatitis 2017-01, Vol.24 (1), p.68-74
Main Authors: Liu, Y., Corsa, A. C., Buti, M., Cathcart, A. L., Flaherty, J. F., Miller, M. D., Kitrinos, K. M., Marcellin, P., Gane, E. J.
Format: Article
Language:English
Subjects:
Adenine - analogs & derivatives
Adenine - therapeutic use
Antiviral Agents - pharmacology
Antiviral Agents - therapeutic use
chronic hepatitis B
DNA, Viral - genetics
Drug Resistance, Viral
Hepatitis B e Antigens - blood
hepatitis B virus
Hepatitis B virus - drug effects
Hepatitis B virus - isolation & purification
Hepatitis B, Chronic - drug therapy
Humans
Mutation
Organophosphonates - therapeutic use
resistance
Sequence Analysis, DNA
tenofovir
Tenofovir - pharmacology
Tenofovir - therapeutic use
tenofovir disoproxil fumarate
viread
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Summary:Summary A major hurdle in the long‐term treatment of chronic hepatitis B (CHB) patients is to maintain viral suppression in the absence of drug resistance. To date, no evidence of resistance to tenofovir disoproxil fumarate (TDF) has been observed. A cumulative evaluation of CHB patients who qualified for resistance surveillance over 8 years of TDF treatment was conducted. Patients in studies GS‐US‐174‐0102 (HBeAg−) and GS‐US‐174‐0103 (HBeAg+) were randomized 2:1 to receive TDF or adefovir dipivoxil (ADV) for 48 weeks followed by open‐label TDF through year 8. Population sequencing of HBV pol/RT was attempted for all TDF‐treated patients at baseline and, annually if viremic, at discontinuation, or with addition of emtricitabine. Overall, 88/641 (13.7%) patients qualified for sequence analysis at one or more time points. The percentage of patients qualifying for sequence analysis declined over time, from 9 to 11% in years 1‐2 to
ISSN:1352-0504
1365-2893
DOI:10.1111/jvh.12613