Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus-infected patients with renal impairment: results from a 7-year, multicentre retrospective cohort study

Vito Di Marco; null Mccorry; Thomas Berg; null Andreone; Gianpiero D'Offizi; Joerg Petersen; Raul Andrade; null Loustaud-Ratti; null Pathil-Warth; Dominique Larrey; null Aoufi Rabih; Maria Buti; null Buti; null Mauss; null Sprinzl; null Madonia; null Goeser; null Aspinall; Teresa Santantonio; Belinda Jump; null Kennedy; Joerg Petersen; Stephen D. Ryder; null Aspinall; null Sellier; Heribert Ramroth; Pietro Lampertico; null Von Der Ohe; null Molina Perez; Fabien Zoulim; null Berg; null Healy; null Sellier; Anna Van Troostenburg; null Weigand; Irina Botros; null Peterson; null Planas; null Ryder; null Jung; null Antoni; Thomas Berg; null Goeser; null Andrade; null Serra Desfilis; null Foxton; null Ciancio; null Ustianowski; null Manzano Alonso; null Molina Perez; null Metivier; null Molina Perez; Heribert Ramroth; null Grambihler; null Foxton; Marjoleine L. Op Den Brouw; null Pascasio Acevedo; null Suarez Garcia; null Manzano Alonso; null Ustianowski; null Gea; null Riachi; null Serra Desfilis; Anna Maria Geretti; Gerlinde Teuber; Alessia Ciancio; Mario Pirisi; null Carrion; null Bourlière; Massimo Puoti; null Antoni; null Leroy; Vito Di Marco; null Weigand; null Dumortier; Pietro Lampertico; Pietro Lampertico; null De Ledinghen; Fabien Zoulim; null Suarez Garcia; John F. Flaherty; null Niederau; Albert Tran; null Agarwal; null Jung; null Schiefke; Mauro Vigano; Anita Pathil

Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus-infected patients with renal impairment: results from a 7-year, multicentre retrospective cohort study

Vito Di Marco, Mccorry, Thomas Berg, Andreone, Gianpiero D'Offizi, Joerg Petersen, Raul Andrade, Loustaud-Ratti, Pathil-Warth, Dominique Larrey, Aoufi Rabih, Maria Buti, Buti, Mauss, Sprinzl, Madonia, Goeser, Aspinall, Teresa Santantonio, Belinda JumpKennedy, Joerg Petersen, Stephen D. Ryder, Aspinall, Sellier, Heribert Ramroth, Pietro Lampertico, Von Der Ohe, Molina Perez, Fabien Zoulim, Berg, Healy, Sellier, Anna Van Troostenburg, Weigand, Irina Botros, Peterson, Planas, Ryder, Jung, Antoni, Thomas Berg, Goeser, Andrade, Serra Desfilis, Foxton, Ciancio, Ustianowski, Manzano Alonso, Molina Perez, Metivier, Molina Perez, Heribert Ramroth, Grambihler, Foxton, Marjoleine L. Op Den Brouw, Pascasio Acevedo, Suarez Garcia, Manzano Alonso, Ustianowski, Gea, Riachi, Serra Desfilis, Anna Maria Geretti, Gerlinde Teuber, Alessia Ciancio, Mario Pirisi, Carrion, Bourlière, Massimo Puoti, Antoni, Leroy, Vito Di Marco, Weigand, Dumortier, Pietro Lampertico, Pietro Lampertico, De Ledinghen, Fabien Zoulim, Suarez Garcia, John F. Flaherty, Niederau, Albert Tran, Agarwal, Jung, Schiefke, Mauro Vigano, Anita Pathil

Promozione della Salute, Materno-Infantile, di Medicina Interna e Specialistica di Eccellenza “G. D’Alessandro”

Risultato della ricerca: Article › peer review

7 Citazioni (Scopus)

Abstract

Background: Limited data exist regarding tenofovir disoproxil fumarate (TDF) safety and effectiveness in chronic hepatitis B virus–infected (CHB) patients with renal impairment (RI). Aims: To compare real-world data on renal safety and effectiveness of TDF vs entecavir (ETV) in CHB patients with moderate-to-severe RI. Methods: Retrospective, non-interventional, cohort study analysing medical records for TDF/ETV-treated CHB patients (54 European centres). Included patients experienced moderate-to-severe RI (creatinine clearance 20-60 mL/min [Cockcroft-Gault]) either before TDF/ETV initiation (‘before’ subgroup [baseline = treatment initiation]) or after TDF/ETV initiation (‘after’ subgroup [baseline = first RI occurrence]). The primary objective was TDF safety, particularly renal-related adverse events of special interest (AESI). TDF and ETV safety and effectiveness were compared and multivariate analyses were performed using inverse probability treatment weighting. Results: ‘Before’ subgroup included 107 TDF- and 91 ETV-treated patients; ‘after’ subgroup included 212 TDF- and 77 ETV-treated patients. Mean baseline creatinine clearance was higher for TDF- vs ETV-treated patients (both subgroups). Median follow-up was 3.1 years (both treatments). AESI were more frequent with TDF vs ETV (‘before’: 18.7% vs 8.8%; ‘after’: 9.9% vs 3.9%); however, differences were not significant by multivariate analysis. Only TDF-treated patients experienced renal tubular dysfunction (6.5% ‘before’; 1.9% ‘after’) as well as renal adverse events leading to treatment discontinuation (8.4% ‘before’; 7.1% ‘after’). Effectiveness was similar between treatments. Conclusions: Overall safety was similar for TDF vs ETV (both subgroups). Given that renal tubular dysfunction occurred with TDF and not with ETV, renal safety concerns may be greater with TDF in CHB patients with RI.

Lingua originale	English
pagine (da-a)	500-512
Numero di pagine	13
Rivista	ALIMENTARY PHARMACOLOGY & THERAPEUTICS
Volume	52
Stato di pubblicazione	Published - 2020

All Science Journal Classification (ASJC) codes

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Di Marco, V., Mccorry, Berg, T., Andreone, D'Offizi, G., Petersen, J., Andrade, R., Loustaud-Ratti, Pathil-Warth, Larrey, D., Aoufi Rabih, Buti, M., Buti, Mauss, Sprinzl, Madonia, Goeser, Aspinall, Santantonio, T., ... Pathil, A. (2020). Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus-infected patients with renal impairment: results from a 7-year, multicentre retrospective cohort study. ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 52, 500-512.

Di Marco, V, Mccorry, Berg, T, Andreone, D'Offizi, G, Petersen, J, Andrade, R, Loustaud-Ratti, Pathil-Warth, Larrey, D, Aoufi Rabih, Buti, M, Buti, Mauss, Sprinzl, Madonia, Goeser, Aspinall, Santantonio, T, Jump, B, Kennedy, Petersen, J, Ryder, SD, Aspinall, Sellier, Ramroth, H, Lampertico, P, Von Der Ohe, Molina Perez, Zoulim, F, Berg, Healy, Sellier, Van Troostenburg, A, Weigand, Botros, I, Peterson, Planas, Ryder, Jung, Antoni, Berg, T, Goeser, Andrade, Serra Desfilis, Foxton, Ciancio, Ustianowski, Manzano Alonso, Molina Perez, Metivier, Molina Perez, Ramroth, H, Grambihler, Foxton, Op Den Brouw, ML, Pascasio Acevedo, Suarez Garcia, Manzano Alonso, Ustianowski, Gea, Riachi, Serra Desfilis, Geretti, AM, Teuber, G, Ciancio, A, Pirisi, M, Carrion, Bourlière, Puoti, M, Antoni, Leroy, Di Marco, V, Weigand, Dumortier, Lampertico, P, Lampertico, P, De Ledinghen, Zoulim, F, Suarez Garcia, Flaherty, JF, Niederau, Tran, A, Agarwal, Jung, Schiefke, Vigano, M & Pathil, A 2020, 'Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus-infected patients with renal impairment: results from a 7-year, multicentre retrospective cohort study', ALIMENTARY PHARMACOLOGY & THERAPEUTICS, vol. 52, pagg. 500-512.

@article{4f43fe0b97e54ba6911f4a4d178b7d40,

title = "Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus-infected patients with renal impairment: results from a 7-year, multicentre retrospective cohort study",

abstract = "Background: Limited data exist regarding tenofovir disoproxil fumarate (TDF) safety and effectiveness in chronic hepatitis B virus–infected (CHB) patients with renal impairment (RI). Aims: To compare real-world data on renal safety and effectiveness of TDF vs entecavir (ETV) in CHB patients with moderate-to-severe RI. Methods: Retrospective, non-interventional, cohort study analysing medical records for TDF/ETV-treated CHB patients (54 European centres). Included patients experienced moderate-to-severe RI (creatinine clearance 20-60 mL/min [Cockcroft-Gault]) either before TDF/ETV initiation ({\textquoteleft}before{\textquoteright} subgroup [baseline = treatment initiation]) or after TDF/ETV initiation ({\textquoteleft}after{\textquoteright} subgroup [baseline = first RI occurrence]). The primary objective was TDF safety, particularly renal-related adverse events of special interest (AESI). TDF and ETV safety and effectiveness were compared and multivariate analyses were performed using inverse probability treatment weighting. Results: {\textquoteleft}Before{\textquoteright} subgroup included 107 TDF- and 91 ETV-treated patients; {\textquoteleft}after{\textquoteright} subgroup included 212 TDF- and 77 ETV-treated patients. Mean baseline creatinine clearance was higher for TDF- vs ETV-treated patients (both subgroups). Median follow-up was 3.1 years (both treatments). AESI were more frequent with TDF vs ETV ({\textquoteleft}before{\textquoteright}: 18.7% vs 8.8%; {\textquoteleft}after{\textquoteright}: 9.9% vs 3.9%); however, differences were not significant by multivariate analysis. Only TDF-treated patients experienced renal tubular dysfunction (6.5% {\textquoteleft}before{\textquoteright}; 1.9% {\textquoteleft}after{\textquoteright}) as well as renal adverse events leading to treatment discontinuation (8.4% {\textquoteleft}before{\textquoteright}; 7.1% {\textquoteleft}after{\textquoteright}). Effectiveness was similar between treatments. Conclusions: Overall safety was similar for TDF vs ETV (both subgroups). Given that renal tubular dysfunction occurred with TDF and not with ETV, renal safety concerns may be greater with TDF in CHB patients with RI.",

author = "{Di Marco}, Vito and Mccorry and Thomas Berg and Andreone and Gianpiero D'Offizi and Joerg Petersen and Raul Andrade and Loustaud-Ratti and Pathil-Warth and Dominique Larrey and {Aoufi Rabih} and Maria Buti and Buti and Mauss and Sprinzl and Madonia and Goeser and Aspinall and Teresa Santantonio and Belinda Jump and Kennedy and Joerg Petersen and Ryder, {Stephen D.} and Aspinall and Sellier and Heribert Ramroth and Pietro Lampertico and {Von Der Ohe} and {Molina Perez} and Fabien Zoulim and Berg and Healy and Sellier and {Van Troostenburg}, Anna and Weigand and Irina Botros and Peterson and Planas and Ryder and Jung and Antoni and Thomas Berg and Goeser and Andrade and {Serra Desfilis} and Foxton and Ciancio and Ustianowski and {Manzano Alonso} and {Molina Perez} and Metivier and {Molina Perez} and Heribert Ramroth and Grambihler and Foxton and {Op Den Brouw}, {Marjoleine L.} and {Pascasio Acevedo} and {Suarez Garcia} and {Manzano Alonso} and Ustianowski and Gea and Riachi and {Serra Desfilis} and Geretti, {Anna Maria} and Gerlinde Teuber and Alessia Ciancio and Mario Pirisi and Carrion and Bourli{\`e}re and Massimo Puoti and Antoni and Leroy and {Di Marco}, Vito and Weigand and Dumortier and Pietro Lampertico and Pietro Lampertico and {De Ledinghen} and Fabien Zoulim and {Suarez Garcia} and Flaherty, {John F.} and Niederau and Albert Tran and Agarwal and Jung and Schiefke and Mauro Vigano and Anita Pathil",

year = "2020",

language = "English",

volume = "52",

pages = "500--512",

journal = "ALIMENTARY PHARMACOLOGY & THERAPEUTICS",

issn = "0269-2813",

}

TY - JOUR

T1 - Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus-infected patients with renal impairment: results from a 7-year, multicentre retrospective cohort study

AU - Di Marco, Vito

AU - Mccorry, null

AU - Berg, Thomas

AU - Andreone, null

AU - D'Offizi, Gianpiero

AU - Petersen, Joerg

AU - Andrade, Raul

AU - Loustaud-Ratti, null

AU - Pathil-Warth, null

AU - Larrey, Dominique

AU - Aoufi Rabih, null

AU - Buti, Maria

AU - Buti, null

AU - Mauss, null

AU - Sprinzl, null

AU - Madonia, null

AU - Goeser, null

AU - Aspinall, null

AU - Santantonio, Teresa

AU - Jump, Belinda

AU - Kennedy, null

AU - Petersen, Joerg

AU - Ryder, Stephen D.

AU - Aspinall, null

AU - Sellier, null

AU - Ramroth, Heribert

AU - Lampertico, Pietro

AU - Von Der Ohe, null

AU - Molina Perez, null

AU - Zoulim, Fabien

AU - Berg, null

AU - Healy, null

AU - Sellier, null

AU - Van Troostenburg, Anna

AU - Weigand, null

AU - Botros, Irina

AU - Peterson, null

AU - Planas, null

AU - Ryder, null

AU - Jung, null

AU - Antoni, null

AU - Berg, Thomas

AU - Goeser, null

AU - Andrade, null

AU - Serra Desfilis, null

AU - Foxton, null

AU - Ciancio, null

AU - Ustianowski, null

AU - Manzano Alonso, null

AU - Molina Perez, null

AU - Metivier, null

AU - Molina Perez, null

AU - Ramroth, Heribert

AU - Grambihler, null

AU - Foxton, null

AU - Op Den Brouw, Marjoleine L.

AU - Pascasio Acevedo, null

AU - Suarez Garcia, null

AU - Manzano Alonso, null

AU - Ustianowski, null

AU - Gea, null

AU - Riachi, null

AU - Serra Desfilis, null

AU - Geretti, Anna Maria

AU - Teuber, Gerlinde

AU - Ciancio, Alessia

AU - Pirisi, Mario

AU - Carrion, null

AU - Bourlière, null

AU - Puoti, Massimo

AU - Antoni, null

AU - Leroy, null

AU - Di Marco, Vito

AU - Weigand, null

AU - Dumortier, null

AU - Lampertico, Pietro

AU - De Ledinghen, null

AU - Zoulim, Fabien

AU - Suarez Garcia, null

AU - Flaherty, John F.

AU - Niederau, null

AU - Tran, Albert

AU - Agarwal, null

AU - Jung, null

AU - Schiefke, null

AU - Vigano, Mauro

AU - Pathil, Anita

PY - 2020

Y1 - 2020

N2 - Background: Limited data exist regarding tenofovir disoproxil fumarate (TDF) safety and effectiveness in chronic hepatitis B virus–infected (CHB) patients with renal impairment (RI). Aims: To compare real-world data on renal safety and effectiveness of TDF vs entecavir (ETV) in CHB patients with moderate-to-severe RI. Methods: Retrospective, non-interventional, cohort study analysing medical records for TDF/ETV-treated CHB patients (54 European centres). Included patients experienced moderate-to-severe RI (creatinine clearance 20-60 mL/min [Cockcroft-Gault]) either before TDF/ETV initiation (‘before’ subgroup [baseline = treatment initiation]) or after TDF/ETV initiation (‘after’ subgroup [baseline = first RI occurrence]). The primary objective was TDF safety, particularly renal-related adverse events of special interest (AESI). TDF and ETV safety and effectiveness were compared and multivariate analyses were performed using inverse probability treatment weighting. Results: ‘Before’ subgroup included 107 TDF- and 91 ETV-treated patients; ‘after’ subgroup included 212 TDF- and 77 ETV-treated patients. Mean baseline creatinine clearance was higher for TDF- vs ETV-treated patients (both subgroups). Median follow-up was 3.1 years (both treatments). AESI were more frequent with TDF vs ETV (‘before’: 18.7% vs 8.8%; ‘after’: 9.9% vs 3.9%); however, differences were not significant by multivariate analysis. Only TDF-treated patients experienced renal tubular dysfunction (6.5% ‘before’; 1.9% ‘after’) as well as renal adverse events leading to treatment discontinuation (8.4% ‘before’; 7.1% ‘after’). Effectiveness was similar between treatments. Conclusions: Overall safety was similar for TDF vs ETV (both subgroups). Given that renal tubular dysfunction occurred with TDF and not with ETV, renal safety concerns may be greater with TDF in CHB patients with RI.

AB - Background: Limited data exist regarding tenofovir disoproxil fumarate (TDF) safety and effectiveness in chronic hepatitis B virus–infected (CHB) patients with renal impairment (RI). Aims: To compare real-world data on renal safety and effectiveness of TDF vs entecavir (ETV) in CHB patients with moderate-to-severe RI. Methods: Retrospective, non-interventional, cohort study analysing medical records for TDF/ETV-treated CHB patients (54 European centres). Included patients experienced moderate-to-severe RI (creatinine clearance 20-60 mL/min [Cockcroft-Gault]) either before TDF/ETV initiation (‘before’ subgroup [baseline = treatment initiation]) or after TDF/ETV initiation (‘after’ subgroup [baseline = first RI occurrence]). The primary objective was TDF safety, particularly renal-related adverse events of special interest (AESI). TDF and ETV safety and effectiveness were compared and multivariate analyses were performed using inverse probability treatment weighting. Results: ‘Before’ subgroup included 107 TDF- and 91 ETV-treated patients; ‘after’ subgroup included 212 TDF- and 77 ETV-treated patients. Mean baseline creatinine clearance was higher for TDF- vs ETV-treated patients (both subgroups). Median follow-up was 3.1 years (both treatments). AESI were more frequent with TDF vs ETV (‘before’: 18.7% vs 8.8%; ‘after’: 9.9% vs 3.9%); however, differences were not significant by multivariate analysis. Only TDF-treated patients experienced renal tubular dysfunction (6.5% ‘before’; 1.9% ‘after’) as well as renal adverse events leading to treatment discontinuation (8.4% ‘before’; 7.1% ‘after’). Effectiveness was similar between treatments. Conclusions: Overall safety was similar for TDF vs ETV (both subgroups). Given that renal tubular dysfunction occurred with TDF and not with ETV, renal safety concerns may be greater with TDF in CHB patients with RI.

UR - http://hdl.handle.net/10447/509984

M3 - Article

SN - 0269-2813

VL - 52

SP - 500

EP - 512

JO - ALIMENTARY PHARMACOLOGY & THERAPEUTICS

JF - ALIMENTARY PHARMACOLOGY & THERAPEUTICS

ER -

Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus-infected patients with renal impairment: results from a 7-year, multicentre retrospective cohort study

Abstract

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