AISF position paper on HCV in immunocompromised patients

Marzano, Alfredo; Angelucci, Emanuele; Astegiano, Marco; Baratelli, Chiara; Biancone, Luigi; Bironzo, Paolo; Brancaccio, Giuseppina; Brunetto, M.R.; Bruno, Raffaele; Burra, Patrizia; Cabras, Maria Giuseppina; Caraceni, Paolo; Chialà, Claudia; Clemente, Maria Grazia; Colli, Agostino; Daniele, Bruno; Degasperi, Elisabetta; Marco, V. Di; Ditto, Maria Chiara; Fagiuoli, Stefano; Ferri, Clodoveo; Gaeta, Giovanni Battista; Grossi, Paolo; Imperatrice, Barbara; Lampertico, Pietro; Macaluso, Fabio Salvatore; Madonia, Salvatore; Marignani, Massimo; Mazzarelli, Chiara; Mella, Alberto; Missale, Gabriele; Parisi, Simone; Pasulo, L.; Puoti, Massimo; Rendina, Maria; Ribaldone, Davide Giuseppe; Rossi, G; Toniutto, Pierluigi; Tucci, Alessandra; Vajro, Pietro; Viganò, Mauro; Volpes, Riccardo; Zignego, Anna Linda; Giannini, Edoardo G.; Miele, Luca; Russo, Francesco Paolo; Petta, Salvatore; Bonora, Stefano; Brignardello, Enrico; Busca, Alessandro; Castaldo, Giuseppe; Cavallo, Federica; Conforti, Massimiliano; Coscia, Marta; Craxı̀, Antonio; Curci, Daniele; Cusinato, Stefano; Maïo, Massimo Di; Valle, Rossella Della; Fusaro, Enrico; Giacardi, A.; Giaccone, Luisa; Lagget, Marco; Libertucci, Daniela; Minutolo, Roberto; Montrucchio, Giuseppe; Orlando, Ambrogio; Orsucci, Lorella; Pasquina, Carla; Pera, A.; Peroni, Clara Lisa; Pirisi, Mario; Racca, Patrizia; Riccardini, Franco; Rizzetto, Mario; Salizzoni, Mauro; Salomone, Mario; Saracco, Giorgio Maria; Scaglione, L.; Torre, Giuliano; Tozzi, Rita; Vitolo, Umberto; Verme, G

doi:10.1016/j.dld.2018.09.022

Cited by 4 publications

(5 citation statements)

References 119 publications

(167 reference statements)

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“…46 Considering the availability of effective and safe antiviral therapies that have demonstrated excellent results also in thalassemia patients, it does not seem justified to consider HCV-RNA-positive subjects as candidates for gene therapy. [47][48][49][50]…”

Section: Hepatitis C Virus Infectionmentioning

confidence: 99%

“…An increase in the risk for fatal VOD in HCV‐positive patients who had received cyclophosphamide and >12 Gy total body irradiation has been observed, but this seems to be correlated to liver inflammation and fibrosis and to the components of the conditioning regimen rather than the HCV itself 46 . Considering the availability of effective and safe antiviral therapies that have demonstrated excellent results also in thalassemia patients, it does not seem justified to consider HCV‐RNA‐positive subjects as candidates for gene therapy 47–50 …”

Section: Liver Diseasementioning

confidence: 99%

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Selecting β-thalassemia Patients for Gene Therapy: A Decision-making Algorithm

Baronciani¹,

Casale

Franceschi

et al. 2021

HemaSphere

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This expert opinion originally developed by a panel of the Italian Society of Thalassemias and Hemoglobinopathies (SITE), reviewed and adopted by the European Hematology Association (EHA) through the EHA Scientific Working Group on Red Cells and Iron, has been developed as priority decision-making algorithm on evidence and consensus with the aim to identify which patients with transfusion-dependent beta-thalassemia (TDT) could benefit from a gene therapy (GT) approach. Even if the wide utilized and high successful allogeneic hematopoietic stem-cell transplantation provides the possibility to cure several patients a new scenario has been opened by GT. Therefore, it is important to establish the patients setting for whom it is priority indicated, particularly in the early phase of the diffuse use outside experimental trials conducted in high selected centers. Moreover, actual price, limited availability, and resources disposal constitute a further indication to a rational and progressive approach to this innovative treatment. To elaborate this algorithm, the experience with allogeneic transplantation has been used has a predictive model. In this large worldwide experience, it has been clearly demonstrated that key for the optimal transplant outcome is optimal transfusion and chelation therapy in the years before the procedure and consequently optimal patient’s clinical condition. In the document, different clinical scenarios have been considered and analyzed for the possible impact on treatment outcome. According to the European Medicine Agency (EMA) for the GT product, this expert opinion must be considered as a dynamic, updatable, priority-based indications for physicians taking care of TDT patients.

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Section: Hepatitis C Virus Infectionmentioning

confidence: 99%

Section: Liver Diseasementioning

confidence: 99%

Selecting β-thalassemia Patients for Gene Therapy: A Decision-making Algorithm

Baronciani¹,

Casale

Franceschi

et al. 2021

HemaSphere

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“…The choice of appropriate DAA regimen was based on HCV genotype, estimated glomerular filtration rate (eGFR), treatment history, and liver transplant function according to the Italian Association of the Study of the Liver (AISF) guidelines. 20 , 21 Ribavirin was prescribed according to eGFR value and body weight (1000 mg daily for weight <75 kg and 1200 mg daily for weight >75 kg). A sofosbuvir (SFB)-free regimen was used in KTR with impaired renal transplant function (GFR lower than 30 ml/min per 1.73 m 2 ).…”

Section: Methodsmentioning

confidence: 99%

HCV-positive kidney transplant patients treated with direct-acting antivirals maintain stable medium-term graft function despite persistent reduction in tacrolimus trough levels

Rendina

Paoletti

Labarile

et al. 2022

Therapeutic Advances in Chronic Disease

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Background/aim: Direct-acting antivirals (DAAs) have improved the treatment of HCV-positive kidney transplant recipients (KTRs). However, their medium-term follow-up effects on graft function are conflicting. This study aimed to analyze how the interplay between DAAs, calcineurin inhibitors (CNI), and HCV eradication impacts 12-month kidney graft function. Methods: This double-center retrospective study with a prospective follow-up enrolled 35 KTRs with HCV treated with DAAs for 12 weeks. We compared three parameters: estimated glomerular filtration rate (eGFR), 24-h proteinuria, and CNI trough levels at three time points: baseline, end of treatment (EOT), and 12 months later. Results: Kidney allograft function remained stable when comparing baseline and 12-month post-treatment values of eGFR (60.7 versus 57.8 ml/min; p = 0.28) and 24-h proteinuria (0.3 versus 0.2 g/24 h; p = 0.15), while tacrolimus (Tac) trough levels underwent a statistically significant decline (6.9 versus 5.4 ng/ml; p = 0.004). Using an ongoing triple Tac-based maintenance therapy as a conservative measure, a dose escalation of Tac was applied only in seven patients. No variation in CyA and mTOR levels was detected. Conclusion: DAA therapy is safe and effective in HCV-positive KTRs. It also produces a persistent significant reduction in Tac trough levels that does not influence graft function at 12 months.

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“…All patients with HCV chronic infection, with the exclusion of patients with limited life expectancy no liver-related, should be treated with direct-acting antiviral agents (DAAs) [20]. Risk of reactivation, defined as a 1 log increase in HCV-RNA levels with respect to the baseline, and rising of the alanine aminotransferase (ALT) level may occur in the HCV-infected patient during immunosuppressive therapies [21].…”

Section: Hepatitis B Virus and Hepatitis C Virusmentioning

confidence: 99%

“…Immunosuppressive therapies in HCV-infected IBD patients seem to not influence the progression of liver disease and the risk of reactivation seems very low. In any case, all IBD patients should be tested for HCV infection prior to immunosuppressive or biologic therapies and if positive should be treated with DAAs [21].…”

Section: Hepatitis C Virusmentioning

confidence: 99%

Review article: safety of new biologic agents for inflammatory bowel disease in the liver

Magrì

Chessa

Demurtas

et al. 2021

European Journal of Gastroenterology &Amp; Hepatology

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New biologic agents (vedolizumab, ustekinumab and tofacitinib) represent an effective treatment for inflammatory bowel diseases and have been recently approved. However, with a rapidly evolving complement of advanced targeted therapies, new concerns about their potentially undesirable effects on liver function emerge. In particular, little is known about safety data in patients with hepatitis B virus, hepatitis C virus chronic infections, cirrhosis and in transplanted patients who are accumulating. In addition, these new agents have also been associated with drug-induced liver injury. Limited data on the efficacy of vedolizumab in patients with primary sclerosing cholangitis are also available. This article reviews available data about hepatic safety concerns in patients receiving vedolizumab, ustekinumab and tofacitinib with and without preexistent hepatic diseases. Eur J Gastroenterol Hepatol XXX: 00-00

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AISF position paper on HCV in immunocompromised patients

Abstract: This report summarizes the clinical features and the indications for treating HCV infection in immunocompromised and transplanted patients in the Direct Acting Antiviral drugs era.

Cited by 4 publications

References 119 publications

Selecting β-thalassemia Patients for Gene Therapy: A Decision-making Algorithm

Selecting β-thalassemia Patients for Gene Therapy: A Decision-making Algorithm

HCV-positive kidney transplant patients treated with direct-acting antivirals maintain stable medium-term graft function despite persistent reduction in tacrolimus trough levels

Review article: safety of new biologic agents for inflammatory bowel disease in the liver

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