Effectiveness and safety of switching to entecavir hepatitis B patients developing kidney dysfunction during tenofovir
Mauro Viganò
U.O. Epatologia, Ospedale San Giuseppe, University of Milan, Milan, Italy
Search for more papers by this authorAlessandro Loglio
CRC “A. M. e A. Migliavacca”, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy
Search for more papers by this authorSara Labanca
U.O. Epatologia, Ospedale San Giuseppe, University of Milan, Milan, Italy
Search for more papers by this authorSerena Zaltron
Clinica Malattie Infettive e Tropicali. Spedali Civili Brescia, University of Brescia, Brescia, Italy
Search for more papers by this authorFrancesco Castelli
Clinica Malattie Infettive e Tropicali. Spedali Civili Brescia, University of Brescia, Brescia, Italy
Search for more papers by this authorPietro Andreone
Dipartimento di Scienze Mediche e Chirurgiche, University of Bologna, Bologna, Italy
Search for more papers by this authorVincenzo Messina
U.O.C. Malattie Infettive, A.O. S. Anna e S. Sebastiano, Caserta, Italy
Search for more papers by this authorRoberto Ganga
S.C Medicina Interna, Ospedale S. Michele A.O. Brotzu, Cagliari, Italy
Search for more papers by this authorNicola Coppola
Malattie Infettive, Second University of Naples, Dipartimento Salute Mentale e Medicina Preventiva, Naples, Italy
Search for more papers by this authorAldo Marrone
Dipartimento di Scienze Mediche, Chirurgiche, Neurologiche, Metaboliche e dell’Invecchiamento, Luigi Vanvitelli University of Campania, Naples, Italy
Search for more papers by this authorMaurizio Russello
U.O.S. Epatologia e Malattie Gastroenteriche dell’A.R.N.A.S. Garibaldi-Nesima, Catania, Italy
Search for more papers by this authorAlfredo Marzano
U.O. Gastroenterologia Universitaria, Ospedale San Giovanni Battista, Città della Salute e della Scienza di Torino, Turin, Italy
Search for more papers by this authorAlessandra Tucci
U.O. Gastroenterologia Universitaria, Ospedale San Giovanni Battista, Città della Salute e della Scienza di Torino, Turin, Italy
Search for more papers by this authorGloria Taliani
Unità di Malattie Infettive e Tropicali, Dipartimento di Medicina Clinica, Sapienza University, Rome, Italy
Search for more papers by this authorMassimo Fasano
UOC Malattie Infettive Ospedale F. Fallacara, Triggiano, Italy
Search for more papers by this authorStefano Fagiuoli
Dipartimento di Gastroenterologia, Epatologia e Trapianto di Fegato, Ospedale Papa Giovanni XXIII, Bergamo, Italy
Search for more papers by this authorErica Villa
Divisione di Gastroenterologia, AOU Policlinico di Modena, University of Modena e Reggio Emilia, Modena, Italy
Search for more papers by this authorFabrizio Bronte
Unità di Gastroenterologia ed Epatologia, DiBiMIS, University of Palermo, Palermo, Italy
Search for more papers by this authorTeresa Santantonio
Dipartimento di Medicina Clinica e Sperimentale, University of Foggia, Foggia, Italy
Search for more papers by this authorGiuseppina Brancaccio
Malattie Infettive, University of Padua, Padua, Italy
Search for more papers by this authorVincenzo Occhipinti
U.O. Epatologia, Ospedale San Giuseppe, University of Milan, Milan, Italy
Search for more papers by this authorFloriana Facchetti
CRC “A. M. e A. Migliavacca”, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy
Search for more papers by this authorGlenda Grossi
CRC “A. M. e A. Migliavacca”, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy
Search for more papers by this authorMariagrazia Rumi
U.O. Epatologia, Ospedale San Giuseppe, University of Milan, Milan, Italy
Search for more papers by this authorCorresponding Author
Pietro Lampertico
CRC “A. M. e A. Migliavacca”, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy
Correspondence
Pietro Lampertico, CRC “A. M. e A. Migliavacca” Center for the Study of Liver Disease, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università di Milano, Milano, Italy.
Email: [email protected]
Search for more papers by this authorMauro Viganò
U.O. Epatologia, Ospedale San Giuseppe, University of Milan, Milan, Italy
Search for more papers by this authorAlessandro Loglio
CRC “A. M. e A. Migliavacca”, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy
Search for more papers by this authorSara Labanca
U.O. Epatologia, Ospedale San Giuseppe, University of Milan, Milan, Italy
Search for more papers by this authorSerena Zaltron
Clinica Malattie Infettive e Tropicali. Spedali Civili Brescia, University of Brescia, Brescia, Italy
Search for more papers by this authorFrancesco Castelli
Clinica Malattie Infettive e Tropicali. Spedali Civili Brescia, University of Brescia, Brescia, Italy
Search for more papers by this authorPietro Andreone
Dipartimento di Scienze Mediche e Chirurgiche, University of Bologna, Bologna, Italy
Search for more papers by this authorVincenzo Messina
U.O.C. Malattie Infettive, A.O. S. Anna e S. Sebastiano, Caserta, Italy
Search for more papers by this authorRoberto Ganga
S.C Medicina Interna, Ospedale S. Michele A.O. Brotzu, Cagliari, Italy
Search for more papers by this authorNicola Coppola
Malattie Infettive, Second University of Naples, Dipartimento Salute Mentale e Medicina Preventiva, Naples, Italy
Search for more papers by this authorAldo Marrone
Dipartimento di Scienze Mediche, Chirurgiche, Neurologiche, Metaboliche e dell’Invecchiamento, Luigi Vanvitelli University of Campania, Naples, Italy
Search for more papers by this authorMaurizio Russello
U.O.S. Epatologia e Malattie Gastroenteriche dell’A.R.N.A.S. Garibaldi-Nesima, Catania, Italy
Search for more papers by this authorAlfredo Marzano
U.O. Gastroenterologia Universitaria, Ospedale San Giovanni Battista, Città della Salute e della Scienza di Torino, Turin, Italy
Search for more papers by this authorAlessandra Tucci
U.O. Gastroenterologia Universitaria, Ospedale San Giovanni Battista, Città della Salute e della Scienza di Torino, Turin, Italy
Search for more papers by this authorGloria Taliani
Unità di Malattie Infettive e Tropicali, Dipartimento di Medicina Clinica, Sapienza University, Rome, Italy
Search for more papers by this authorMassimo Fasano
UOC Malattie Infettive Ospedale F. Fallacara, Triggiano, Italy
Search for more papers by this authorStefano Fagiuoli
Dipartimento di Gastroenterologia, Epatologia e Trapianto di Fegato, Ospedale Papa Giovanni XXIII, Bergamo, Italy
Search for more papers by this authorErica Villa
Divisione di Gastroenterologia, AOU Policlinico di Modena, University of Modena e Reggio Emilia, Modena, Italy
Search for more papers by this authorFabrizio Bronte
Unità di Gastroenterologia ed Epatologia, DiBiMIS, University of Palermo, Palermo, Italy
Search for more papers by this authorTeresa Santantonio
Dipartimento di Medicina Clinica e Sperimentale, University of Foggia, Foggia, Italy
Search for more papers by this authorGiuseppina Brancaccio
Malattie Infettive, University of Padua, Padua, Italy
Search for more papers by this authorVincenzo Occhipinti
U.O. Epatologia, Ospedale San Giuseppe, University of Milan, Milan, Italy
Search for more papers by this authorFloriana Facchetti
CRC “A. M. e A. Migliavacca”, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy
Search for more papers by this authorGlenda Grossi
CRC “A. M. e A. Migliavacca”, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy
Search for more papers by this authorMariagrazia Rumi
U.O. Epatologia, Ospedale San Giuseppe, University of Milan, Milan, Italy
Search for more papers by this authorCorresponding Author
Pietro Lampertico
CRC “A. M. e A. Migliavacca”, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy
Correspondence
Pietro Lampertico, CRC “A. M. e A. Migliavacca” Center for the Study of Liver Disease, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università di Milano, Milano, Italy.
Email: [email protected]
Search for more papers by this authorFunding information
The study is partially supported by Italian Ministry of Health (Ricerca Corrente 2018—105/01).
Abstract
Background and Aims
Tenofovir disoproxil fumarate (TDF) is recommended for chronic hepatitis B (CHB) treatment, but it may induce kidney dysfunction whose management is not yet known. This Italian, multicentre, retrospective study aimed to assess the efficacy and safety of switching to entecavir (ETV) patients who developed TDF-associated glomerular and/or tubular dysfunction.
Methods
A total of 103 TDF-treated patients were included as follows: age 64 years, 83% male, 49% cirrhotics, 98% with undetectable HBV DNA, 47% with previous lamivudine resistance (LMV-R) and 71% previously treated with adefovir. Twenty-nine (28%) were switched to ETV because estimated glomerular filtration rate (eGFRMDRD) was <60 mL/min, 37 (36%) because blood phosphate (P) levels were <2.5 mg/dL and 37 (36%) for both reasons. Kidney, liver and virological parameters were recorded every 4 months thereafter.
Results
During 46 (4-115) months of ETV treatment, all patients’ renal parameters significantly improved as follows: creatinine from 1.30 to 1.10 mg/dL (P < 0.0001), eGFRMDRD from 54 to 65 mL/min (P = 0.002), P from 2.2 to 2.6 mg/dL (P < 0.0001) and maximal tubule phosphate reabsorption (TmPO4/eGFR) from 0.47 to 0.62 mmol/L (P < 0.0001). Thirteen patients (52%) improved their eGFRMDRD class, P levels were normalised in 13 (35%), and eight (22%) showed improvements in both parameters. Viral suppression was maintained in all but five patients (5%), all of whom had been LMV-R. The 5-year cumulative probability of ETV-R was 0% in LMV-naïve patients, and 11% in LMV-R patients (P = 0.018).
Conclusions
Entecavir is an effective and safe rescue strategy for CHB patients who develop renal dysfunction during long-term TDF treatment.
CONFLICT OF INTEREST
M. Viganò: consultant/advisor/sponsored lecturer for BMS, Gilead and Roche. P. Andreone: research grants from Gilead, MSD and Roche; advisor for Janssen, MSD, Roche, AbbVie, BMS, Gilead and Intercept. S. Fagiuoli: Speaking Bureau of Gilead, BMS, MSD, Abbvie, Janssen and Novartis. G. Taliani: travel grant, speaker, teacher and member of Advisory Board of AbbVie, BMS, Gilead, MSD, Janssen and Roche. E. Villa: Member of Advisory Committee or Review Panel of Abbvie, BMS, Gilead, GlaxoSmithKline, MSD and Roche; speaker and teacher for Abbvie, GlaxoSmithKline and Novartis. P. Lampertico: Speaking bureau/advisory board of BMS, Roche, Gilead, GSK and MSD. V. Messina: research grants from Janssen and Roche; consultant/advisor/sponsored lecturer for Abbvie, Gilead and BMS. Others: nothing to declare.
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