Combined Analysis of the Prevalence of Drug-Resistant Hepatitis B Virus in Antiviral Therapy-Experienced Patients in Europe (CAPRE)

Lucas Etienne Hermans; Valentina Svicher; Suzan Diepstraten Pas; Romina Salpini; Marta Alvarez; Ziv Ben Ari; Greet Boland; Bianca Bruzzone; Nicola Coppola; Carole Seguin-Devaux; Tomasz Dyda; Federico Garcia; Rolf Kaiser; Sukran Köse; Henrik Krarup; Ivana Lazarevic; Maja M Lunar; Sarah Maylin; Valeria Micheli; Orna Mor; Simona Paraschiv; Dimitrios Paraskevis; Mario Poljak; Elisabeth Puchhammer-Stöckl; François Simon; Maja Stanojevic; Kathrine Stene-Johansen; Nijaz Tihic; Pascale Trimoulet; Jens Verheyen; Adriana Vince; Nina Weis; Tülay Yalcinkaya; Snjezana Zidovec Lepej; Carlo Perno; Charles A B Boucher; Annemarie M J Wensing; HEPVIR Working Group of the European Society for Translational Antiviral Research

doi:10.1093/infdis/jiv363

Combined Analysis of the Prevalence of Drug-Resistant Hepatitis B Virus in Antiviral Therapy-Experienced Patients in Europe (CAPRE)

Lucas Etienne Hermans, Valentina Svicher, Suzan Diepstraten Pas, Romina Salpini, Marta Alvarez, Ziv Ben Ari, Greet Boland, Bianca Bruzzone, Nicola Coppola, Carole Seguin-Devaux, Tomasz Dyda, Federico Garcia, Rolf Kaiser, Sukran Köse, Henrik Krarup, Ivana Lazarevic, Maja M Lunar, Sarah Maylin, Valeria Micheli, Orna MorSimona Paraschiv, Dimitrios Paraskevis, Mario Poljak, Elisabeth Puchhammer-Stöckl, François Simon, Maja Stanojevic, Kathrine Stene-Johansen, Nijaz Tihic, Pascale Trimoulet, Jens Verheyen, Adriana Vince, Nina Weis, Tülay Yalcinkaya, Snjezana Zidovec Lepej, Carlo Perno, Charles A B Boucher, Annemarie M J Wensing, HEPVIR Working Group of the European Society for Translational Antiviral Research

Institut for Klinisk Medicin

23 Citationer (Scopus)

Abstract

Background 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 hepatitis B virus DNA in European tertiary referral centers. Results Data from 1568 patients were included. The majority (73.8%) were 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 <. 001). Conclusions 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.

Originalsprog	Engelsk
Tidsskrift	The Journal of Infectious Diseases
Vol/bind	213
Udgave nummer	1
Sider (fra-til)	39-48
Antal sider	10
ISSN	0022-1899
DOI	https://doi.org/10.1093/infdis/jiv363
Status	Udgivet - 1 jan. 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 (2016). Combined Analysis of the Prevalence of Drug-Resistant Hepatitis B Virus in Antiviral Therapy-Experienced Patients in Europe (CAPRE). The Journal of Infectious Diseases, 213(1), 39-48. https://doi.org/10.1093/infdis/jiv363

Combined Analysis of the Prevalence of Drug-Resistant Hepatitis B Virus in Antiviral Therapy-Experienced Patients in Europe (CAPRE). / Hermans, Lucas Etienne; Svicher, Valentina; Pas, Suzan Diepstraten et al.
I: The Journal of Infectious Diseases, Bind 213, Nr. 1, 01.01.2016, s. 39-48.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

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, Lepej, SZ, Perno, C, Boucher, CAB, Wensing, AMJ & HEPVIR Working Group of the European Society for Translational Antiviral Research 2016, 'Combined Analysis of the Prevalence of Drug-Resistant Hepatitis B Virus in Antiviral Therapy-Experienced Patients in Europe (CAPRE)', The Journal of Infectious Diseases, bind 213, nr. 1, s. 39-48. https://doi.org/10.1093/infdis/jiv363

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title = "Combined Analysis of the Prevalence of Drug-Resistant Hepatitis B Virus in Antiviral Therapy-Experienced Patients in Europe (CAPRE)",

abstract = "Background 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 hepatitis B virus DNA in European tertiary referral centers. Results Data from 1568 patients were included. The majority (73.8%) were 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 <. 001). Conclusions 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.",

keywords = "Adult, Antiviral Agents, Cross-Sectional Studies, Drug Resistance, Viral, Female, Genotype, Hepatitis B virus, Hepatitis B, Chronic, Humans, Male, Middle Aged, Prevalence",

author = "Hermans, {Lucas Etienne} and Valentina Svicher and Pas, {Suzan Diepstraten} and Romina Salpini and Marta Alvarez and {Ben Ari}, Ziv and Greet Boland and Bianca Bruzzone and Nicola Coppola and Carole Seguin-Devaux and Tomasz Dyda and Federico Garcia and Rolf Kaiser and Sukran K{\"o}se and Henrik Krarup and Ivana Lazarevic and Lunar, {Maja M} and Sarah Maylin and Valeria Micheli and Orna Mor and Simona Paraschiv and Dimitrios Paraskevis and Mario Poljak and Elisabeth Puchhammer-St{\"o}ckl and Fran{\c c}ois Simon and Maja Stanojevic and Kathrine Stene-Johansen and Nijaz Tihic and Pascale Trimoulet and Jens Verheyen and Adriana Vince and Nina Weis and T{\"u}lay Yalcinkaya and Lepej, {Snjezana Zidovec} and Carlo Perno and Boucher, {Charles A B} and Wensing, {Annemarie M J} and {HEPVIR Working Group of the European Society for Translational Antiviral Research}",

year = "2016",

month = jan,

day = "1",

doi = "10.1093/infdis/jiv363",

language = "English",

volume = "213",

pages = "39--48",

journal = "The Journal of Infectious Diseases",

issn = "0022-1899",

publisher = "Oxford University Press",

number = "1",

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TY - JOUR

T1 - Combined Analysis of the Prevalence of Drug-Resistant Hepatitis B Virus in Antiviral Therapy-Experienced Patients in Europe (CAPRE)

AU - Hermans, Lucas Etienne

AU - Svicher, Valentina

AU - Pas, Suzan Diepstraten

AU - Salpini, Romina

AU - Alvarez, Marta

AU - Ben Ari, Ziv

AU - Boland, Greet

AU - Bruzzone, Bianca

AU - Coppola, Nicola

AU - Seguin-Devaux, Carole

AU - Dyda, Tomasz

AU - Garcia, Federico

AU - Kaiser, Rolf

AU - Köse, Sukran

AU - Krarup, Henrik

AU - Lazarevic, Ivana

AU - Lunar, Maja M

AU - Maylin, Sarah

AU - Micheli, Valeria

AU - Mor, Orna

AU - Paraschiv, Simona

AU - Paraskevis, Dimitrios

AU - Poljak, Mario

AU - Puchhammer-Stöckl, Elisabeth

AU - Simon, François

AU - Stanojevic, Maja

AU - Stene-Johansen, Kathrine

AU - Tihic, Nijaz

AU - Trimoulet, Pascale

AU - Verheyen, Jens

AU - Vince, Adriana

AU - Weis, Nina

AU - Yalcinkaya, Tülay

AU - Lepej, Snjezana Zidovec

AU - Perno, Carlo

AU - Boucher, Charles A B

AU - Wensing, Annemarie M J

AU - HEPVIR Working Group of the European Society for Translational Antiviral Research

PY - 2016/1/1

Y1 - 2016/1/1

N2 - Background 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 hepatitis B virus DNA in European tertiary referral centers. Results Data from 1568 patients were included. The majority (73.8%) were 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 <. 001). Conclusions 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 - Background 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 hepatitis B virus DNA in European tertiary referral centers. Results Data from 1568 patients were included. The majority (73.8%) were 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 <. 001). Conclusions 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.

KW - Adult

KW - Antiviral Agents

KW - Cross-Sectional Studies

KW - Drug Resistance, Viral

KW - Female

KW - Genotype

KW - Hepatitis B virus

KW - Hepatitis B, Chronic

KW - Humans

KW - Male

KW - Middle Aged

KW - Prevalence

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 - The Journal of Infectious Diseases

JF - The 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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