Combined Analysis of the Prevalence of drug Resistant Hepatitis B Virus in antiviral therapy Experienced patients in Europe (CAPRE)

L E Hermans; V Svicher; S D Pas; R Salpini; M Alvarez; Z Ben Ari; G Boland; B Bruzzone; N Coppola; C Seguin-Devaux; T Dyda; F Garcia; R Kaiser; S Köse; H Krarup; I Lazarevic; M M Lunar; S Maylin; V Micheli; O Mor; S Paraschiv; D Paraskevis; M Poljak; E Puchhammer-Stöckl; F Simon; M Stanojevic; K Stene-Johansen; N Tihic; P Trimoulet; J Verheyen; A Vince; N Weis; T Yalcinkaya; S Zidovec Lepej; C Perno; C A B Boucher; A M J Wensing; HEPVIR working group of the European Society for translational antiviral research (ESAR)

doi:10.1093/infdis/jiv363

Combined Analysis of the Prevalence of drug Resistant Hepatitis B Virus in antiviral therapy Experienced patients in Europe (CAPRE)

L E Hermans, V Svicher, S D Pas, R Salpini, M Alvarez, Z Ben Ari, G Boland, B Bruzzone, N Coppola, C Seguin-Devaux, T Dyda, F Garcia, R Kaiser, S Köse, H Krarup, I Lazarevic, M M Lunar, S Maylin, V Micheli, O MorS Paraschiv, D Paraskevis, M Poljak, E Puchhammer-Stöckl, F Simon, M Stanojevic, K Stene-Johansen, N Tihic, P Trimoulet, J Verheyen, A Vince, N Weis, T Yalcinkaya, S Zidovec Lepej, C Perno, C A B Boucher, A M J Wensing, HEPVIR working group of the European Society for translational antiviral research (ESAR)

Research output: Contribution to journal › Journal article › Research › peer-review

25 Citations (Scopus)

Abstract

INTRODUCTION: European guidelines recommend treatment of chronic Hepatitis B virus infection (CHB) with the nucleos(t)ide analogs (NAs) entecavir or tenofovir. However, many European CHB patients have been exposed to other NAs, which are associated with therapy failure and resistance. The CAPRE study was performed to gain insight in prevalence and characteristics of NA resistance in Europe.

METHODS: A survey was performed on genotypic resistance testing results acquired during routine monitoring of CHB patients with detectable serum HBV-DNA in European tertiary referral centres.

RESULTS: Data of 1568 patients was included. The majority (73.8%) was exposed to lamivudine monotherapy. Drug resistant strains were detected in 52.7%. The most frequently encountered primary mutation was M204V/I (48.7%), followed by A181T/V (3.8%) and N236T (2.6%). In patients exposed to entecavir (n=102), full resistance was present in 35.3%. Independent risk factors for resistance were age, viral load and lamivudine exposure (p<0.001).

CONCLUSION: These findings support resistance testing in cases of apparent NA therapy failure. This survey highlights the impact of exposure to lamivudine and adefovir on development of drug resistance and cross-resistance. Continued use of these NAs needs to be reconsidered at a pan-European level.

Original language	English
Journal	Journal of Infectious Diseases
Volume	213
Issue number	1
Pages (from-to)	39-48
Number of pages	10
ISSN	0022-1899
DOIs	https://doi.org/10.1093/infdis/jiv363
Publication status	Published - 2016

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Hermans, L. E., Svicher, V., Pas, S. D., Salpini, R., Alvarez, M., Ben Ari, Z., Boland, G., Bruzzone, B., Coppola, N., Seguin-Devaux, C., Dyda, T., Garcia, F., Kaiser, R., Köse, S., Krarup, H., Lazarevic, I., Lunar, M. M., Maylin, S., Micheli, V., ... HEPVIR working group of the European Society for translational antiviral research (ESAR) (2016). Combined Analysis of the Prevalence of drug Resistant Hepatitis B Virus in antiviral therapy Experienced patients in Europe (CAPRE). Journal of Infectious Diseases, 213(1), 39-48. https://doi.org/10.1093/infdis/jiv363

@article{fb7ca3b1156d4fdcaff935eea424eaae,

title = "Combined Analysis of the Prevalence of drug Resistant Hepatitis B Virus in antiviral therapy Experienced patients in Europe (CAPRE)",

abstract = "INTRODUCTION: European guidelines recommend treatment of chronic Hepatitis B virus infection (CHB) with the nucleos(t)ide analogs (NAs) entecavir or tenofovir. However, many European CHB patients have been exposed to other NAs, which are associated with therapy failure and resistance. The CAPRE study was performed to gain insight in prevalence and characteristics of NA resistance in Europe.METHODS: A survey was performed on genotypic resistance testing results acquired during routine monitoring of CHB patients with detectable serum HBV-DNA in European tertiary referral centres.RESULTS: Data of 1568 patients was included. The majority (73.8%) was exposed to lamivudine monotherapy. Drug resistant strains were detected in 52.7%. The most frequently encountered primary mutation was M204V/I (48.7%), followed by A181T/V (3.8%) and N236T (2.6%). In patients exposed to entecavir (n=102), full resistance was present in 35.3%. Independent risk factors for resistance were age, viral load and lamivudine exposure (p<0.001).CONCLUSION: These findings support resistance testing in cases of apparent NA therapy failure. This survey highlights the impact of exposure to lamivudine and adefovir on development of drug resistance and cross-resistance. Continued use of these NAs needs to be reconsidered at a pan-European level.",

author = "Hermans, {L E} and V Svicher and Pas, {S D} and R Salpini and M Alvarez and {Ben Ari}, Z and G Boland and B Bruzzone and N Coppola and C Seguin-Devaux and T Dyda and F Garcia and R Kaiser and S K{\"o}se and H Krarup and I Lazarevic and Lunar, {M M} and S Maylin and V Micheli and O Mor and S Paraschiv and D Paraskevis and M Poljak and E Puchhammer-St{\"o}ckl and F Simon and M Stanojevic and K Stene-Johansen and N Tihic and P Trimoulet and J Verheyen and A Vince and N Weis and T Yalcinkaya and {Zidovec Lepej}, S and C Perno and Boucher, {C A B} and Wensing, {A M J} and {HEPVIR working group of the European Society for translational antiviral research (ESAR)}",

note = "{\textcopyright} The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.",

year = "2016",

doi = "10.1093/infdis/jiv363",

language = "English",

volume = "213",

pages = "39--48",

journal = "Journal of Infectious Diseases",

issn = "0022-1899",

publisher = "Oxford University Press",

number = "1",

}

Hermans, LE, Svicher, V, Pas, SD, Salpini, R, Alvarez, M, Ben Ari, Z, Boland, G, Bruzzone, B, Coppola, N, Seguin-Devaux, C, Dyda, T, Garcia, F, Kaiser, R, Köse, S, Krarup, H, Lazarevic, I, Lunar, MM, Maylin, S, Micheli, V, Mor, O, Paraschiv, S, Paraskevis, D, Poljak, M, Puchhammer-Stöckl, E, Simon, F, Stanojevic, M, Stene-Johansen, K, Tihic, N, Trimoulet, P, Verheyen, J, Vince, A, Weis, N, Yalcinkaya, T, Zidovec Lepej, S, Perno, C, Boucher, CAB, Wensing, AMJ & HEPVIR working group of the European Society for translational antiviral research (ESAR) 2016, 'Combined Analysis of the Prevalence of drug Resistant Hepatitis B Virus in antiviral therapy Experienced patients in Europe (CAPRE)', Journal of Infectious Diseases, vol. 213, no. 1, pp. 39-48. https://doi.org/10.1093/infdis/jiv363

TY - JOUR

T1 - Combined Analysis of the Prevalence of drug Resistant Hepatitis B Virus in antiviral therapy Experienced patients in Europe (CAPRE)

AU - Hermans, L E

AU - Svicher, V

AU - Pas, S D

AU - Salpini, R

AU - Alvarez, M

AU - Ben Ari, Z

AU - Boland, G

AU - Bruzzone, B

AU - Coppola, N

AU - Seguin-Devaux, C

AU - Dyda, T

AU - Garcia, F

AU - Kaiser, R

AU - Köse, S

AU - Krarup, H

AU - Lazarevic, I

AU - Lunar, M M

AU - Maylin, S

AU - Micheli, V

AU - Mor, O

AU - Paraschiv, S

AU - Paraskevis, D

AU - Poljak, M

AU - Puchhammer-Stöckl, E

AU - Simon, F

AU - Stanojevic, M

AU - Stene-Johansen, K

AU - Tihic, N

AU - Trimoulet, P

AU - Verheyen, J

AU - Vince, A

AU - Weis, N

AU - Yalcinkaya, T

AU - Zidovec Lepej, S

AU - Perno, C

AU - Boucher, C A B

AU - Wensing, A M J

AU - HEPVIR working group of the European Society for translational antiviral research (ESAR)

PY - 2016

Y1 - 2016

N2 - INTRODUCTION: European guidelines recommend treatment of chronic Hepatitis B virus infection (CHB) with the nucleos(t)ide analogs (NAs) entecavir or tenofovir. However, many European CHB patients have been exposed to other NAs, which are associated with therapy failure and resistance. The CAPRE study was performed to gain insight in prevalence and characteristics of NA resistance in Europe.METHODS: A survey was performed on genotypic resistance testing results acquired during routine monitoring of CHB patients with detectable serum HBV-DNA in European tertiary referral centres.RESULTS: Data of 1568 patients was included. The majority (73.8%) was exposed to lamivudine monotherapy. Drug resistant strains were detected in 52.7%. The most frequently encountered primary mutation was M204V/I (48.7%), followed by A181T/V (3.8%) and N236T (2.6%). In patients exposed to entecavir (n=102), full resistance was present in 35.3%. Independent risk factors for resistance were age, viral load and lamivudine exposure (p<0.001).CONCLUSION: These findings support resistance testing in cases of apparent NA therapy failure. This survey highlights the impact of exposure to lamivudine and adefovir on development of drug resistance and cross-resistance. Continued use of these NAs needs to be reconsidered at a pan-European level.

AB - INTRODUCTION: European guidelines recommend treatment of chronic Hepatitis B virus infection (CHB) with the nucleos(t)ide analogs (NAs) entecavir or tenofovir. However, many European CHB patients have been exposed to other NAs, which are associated with therapy failure and resistance. The CAPRE study was performed to gain insight in prevalence and characteristics of NA resistance in Europe.METHODS: A survey was performed on genotypic resistance testing results acquired during routine monitoring of CHB patients with detectable serum HBV-DNA in European tertiary referral centres.RESULTS: Data of 1568 patients was included. The majority (73.8%) was exposed to lamivudine monotherapy. Drug resistant strains were detected in 52.7%. The most frequently encountered primary mutation was M204V/I (48.7%), followed by A181T/V (3.8%) and N236T (2.6%). In patients exposed to entecavir (n=102), full resistance was present in 35.3%. Independent risk factors for resistance were age, viral load and lamivudine exposure (p<0.001).CONCLUSION: These findings support resistance testing in cases of apparent NA therapy failure. This survey highlights the impact of exposure to lamivudine and adefovir on development of drug resistance and cross-resistance. Continued use of these NAs needs to be reconsidered at a pan-European level.

U2 - 10.1093/infdis/jiv363

DO - 10.1093/infdis/jiv363

M3 - Journal article

C2 - 26136470

SN - 0022-1899

VL - 213

SP - 39

EP - 48

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

IS - 1

ER -

Combined Analysis of the Prevalence of drug Resistant Hepatitis B Virus in antiviral therapy Experienced patients in Europe (CAPRE)

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