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1,397 results on '"Rostaing, L."'

2. A Randomized Trial Comparing Imlifidase to Plasmapheresis in Kidney Transplant Recipients With Antibody-Mediated Rejection.

Author

Halleck, F, Böhmig, GA, Couzi, L, Rostaing, L, Einecke, G, Lefaucheur, C, Legendre, C, Montgomery, R, Hughes, P, Chandraker, A, Wyburn, K, Halloran, P, Maldonado, AQ, Sjöholm, K, Runström, A, Lefèvre, P, Tollemar, J, Jordan, S, Halleck, F, Böhmig, GA, Couzi, L, Rostaing, L, Einecke, G, Lefaucheur, C, Legendre, C, Montgomery, R, Hughes, P, Chandraker, A, Wyburn, K, Halloran, P, Maldonado, AQ, Sjöholm, K, Runström, A, Lefèvre, P, Tollemar, J, and Jordan, S

Abstract

BACKGROUND: Antibody-mediated rejection (ABMR) poses a barrier to long-term graft survival and is one of the most challenging events after kidney transplantation. Removing donor specific antibodies (DSA) through therapeutic plasma exchange (PLEX) is a cornerstone of antibody depletion but has inconsistent effects. Imlifidase is a treatment currently utilized for desensitization with near-complete inactivation of DSA both in the intra- and extravascular space. METHODS: This was a 6-month, randomized, open-label, multicenter, multinational trial conducted at 14 transplant centers. Thirty patients were randomized to either imlifidase or PLEX treatment. The primary endpoint was reduction in DSA level during the 5 days following the start of treatment. RESULTS: Despite considerable heterogeneity in the trial population, DSA reduction as defined by the primary endpoint was 97% for imlifidase compared to 42% for PLEX. Additionally, imlifidase reduced DSA to noncomplement fixing levels, whereas PLEX failed to do so. After antibody rebound in the imlifidase arm (circa days 6-12), both arms had similar reductions in DSA. Five allograft losses occurred during the 6 months following the start of ABMR treatment-four within the imlifidase arm (18 patients treated) and one in the PLEX arm (10 patients treated). In terms of clinical efficacy, the Kaplan-Meier estimated graft survival was 78% for imlifidase and 89% for PLEX, with a slightly higher eGFR in the PLEX arm at the end of the trial. The observed adverse events in the trial were as expected, and there were no apparent differences between the arms. CONCLUSION: Imlifidase was safe and well-tolerated in the ABMR population. Despite meeting the primary endpoint of maximum DSA reduction compared to PLEX, the trial was unsuccessful in demonstrating a clinical benefit of imlifidase in this heterogenous ABMR population. TRIAL REGISTRATION: EudraCT number: 2018-000022-66, 2020-004777-49; ClinicalTrials.gov identifier: NCT03897205, N

Published
2024

6. Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study

Author

Feng, Sandy, Klintmalm, GB, Lake, JR, Vargas, HE, Wekerle, T, Agnes, S, Brown, KA, Nashan, B, Rostaing, L, and Meadows-Shropshire, S

Abstract

This exploratory phase II study evaluated the safety and efficacy of belatacept in de novo adult liver transplant recipients. Patients were randomized (N=260) to one of the following immunosuppressive regimens: (i) basiliximab+belatacept high dose [HD]+myc

Published
2014

7. Reduction of Extended-Release Tacrolimus Dose in Low-Immunological-Risk Kidney Transplant Recipients Increases Risk of Rejection and Appearance of Donor-Specific Antibodies: A Randomized Study

Author

Gatault, P., Kamar, N., Büchler, M., Colosio, C., Bertrand, D., Durrbach, A., Albano, L., Rivalan, J., Le Meur, Y., Essig, M., Bouvier, N., Legendre, C., Moulin, B., Heng, A.-E., Weestel, P.-F., Sayegh, J., Charpentier, B., Rostaing, L., Thervet, E., and Lebranchu, Y.

Published
2017
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15. Application of machine learning to predict tacrolimus exposure in liver and kidney transplant patients given the MeltDose formulation

Author

Ponthier, L., Marquet, P., Moes, D.J.A.R., Rostaing, L., Hoek, B. van, Monchaud, C., Labriffe, M., and Woillard, J.B.

Subjects
Pharmacology, Tacrolimus MeltDose, Transplantation, Model informed precision dosing, Machine learning, Pharmacology (medical), General Medicine, Population pharmacokinetics
Abstract

Purpose: Machine Learning (ML) algorithms represent an interesting alternative to maximum a posteriori Bayesian estimators (MAP-BE) for tacrolimus AUC estimation, but it is not known if training an ML model using a lower number of full pharmacokinetic (PK) profiles (="true" reference AUC) provides better performances than using a larger dataset of less accurate AUC estimates. The objectives of this study were: to develop and benchmark ML algorithms trained using full PK profiles to estimate MeltDose (R)-tacrolimus individual AUCs using 2 or 3 blood concentrations; and to compare their performance to MAP-BE. Methods: Data from liver (n = 113) and kidney (n = 97) transplant recipients involved in MeltDose-tacrolimus PK studies were used for the training and evaluation of ML algorithms. "True" AUC0-24 h was calculated for each patient using the trapezoidal rule on the full PK profile. ML algorithms were trained to estimate tacrolimus true AUC using 2 or 3 blood concentrations. Performances were evaluated in 2 external sets of 16 (renal) and 48 (liver) transplant patients. Results: Best estimation performances were obtained with the MARS algorithm and the following limited sampling strategies (LSS): predose (0), 8, and 12 h post-dose (rMPE = -1.28%, rRMSE = 7.57%), or 0 and 12 h (rMPE = -1.9%, rRMSE = 10.06%). In the external dataset, the performances of the final ML algorithms based on two samples in kidney (rMPE = -3.1%, rRMSE = 11.1%) or liver transplant recipients (rMPE = -3.4%, rRMSE = 9.86%) were as good as or better than those of MAP-BEs based on three time points. Conclusion: The MARS ML models developed using "true" MeltDose (R)-tacrolimus AUCs yielded accurate individual estimations using only two blood concentrations.

Published
2022

21. Hepatocellular carcinoma progression during bridging before liver transplantation

Author

Renner, P, Da Silva, T, Schnitzbauer, A, Verloh, N, Schlitt, H, Geissler, E, Zulke, C, Lamby, P, Proneth, A, Duvoux, C, Burra, P, Jauch, K, Rentsch, M, Ganten, T, Schmidt, J, Settmacher, U, Heise, M, Rossi, G, Cillo, U, Kneteman, N, Adam, R, Van Hoek, B, Bachellier, P, Wolf, P, Rostaing, L, Bechstein, W, Rizell, M, Powell, J, Hidalgo, E, Gugenheim, J, Wolters, H, Brockmann, J, Roy, A, Mutzbauer, I, Schlitt, A, Beckebaum, S, Graeb, C, Nadalin, S, Valente, U, Sanchez Turrion, V, Jamieson, N, Scholz, T, Colledan, M, Fandrich, F, Becker, T, Soderdahl, G, Chazouilleres, O, Makisalo, H, Pageaux, G, Steininger, R, Soliman, T, De Jong, K, Pirenne, J, Margreiter, R, Pratschke, J, Pinna, A, Hauss, J, Schreiber, S, Strasser, S, Klempnauer, J, Troisi, R, Bhoori, S, Lerut, J, Bilbao, I, Klein, C, Konigsrainer, A, Otto, G, Mazzaferro, V, Neuhaus, P, Renner P., Da Silva T., Schnitzbauer A. A., Verloh N., Schlitt H. J., Geissler E. K., Zulke C., Lamby P. E., Proneth A., Duvoux C., Burra P., Jauch K. -W., Rentsch M., Ganten T. M., Schmidt J., Settmacher U., Heise M., Rossi G., Cillo U., Kneteman N., Adam R., Van Hoek B., Bachellier P., Wolf P., Rostaing L., Bechstein W. O., Rizell M., Powell J., Hidalgo E., Gugenheim J., Wolters H., Brockmann J., Roy A., Mutzbauer I., Schlitt A., Beckebaum S., Graeb C., Nadalin S., Valente U., Sanchez Turrion V., Jamieson N., Scholz T., Colledan M., Fandrich F., Becker T., Soderdahl G., Chazouilleres O., Makisalo H., Pageaux G. -P., Steininger R., Soliman T., De Jong K. P., Pirenne J., Margreiter R., Pratschke J., Pinna A. D., Hauss J., Schreiber S., Strasser S., Klempnauer J., Troisi R. I., Bhoori S., Lerut J., Bilbao I., Klein C. G., Konigsrainer A., Otto G., Mazzaferro V., Neuhaus P., Renner, P, Da Silva, T, Schnitzbauer, A, Verloh, N, Schlitt, H, Geissler, E, Zulke, C, Lamby, P, Proneth, A, Duvoux, C, Burra, P, Jauch, K, Rentsch, M, Ganten, T, Schmidt, J, Settmacher, U, Heise, M, Rossi, G, Cillo, U, Kneteman, N, Adam, R, Van Hoek, B, Bachellier, P, Wolf, P, Rostaing, L, Bechstein, W, Rizell, M, Powell, J, Hidalgo, E, Gugenheim, J, Wolters, H, Brockmann, J, Roy, A, Mutzbauer, I, Schlitt, A, Beckebaum, S, Graeb, C, Nadalin, S, Valente, U, Sanchez Turrion, V, Jamieson, N, Scholz, T, Colledan, M, Fandrich, F, Becker, T, Soderdahl, G, Chazouilleres, O, Makisalo, H, Pageaux, G, Steininger, R, Soliman, T, De Jong, K, Pirenne, J, Margreiter, R, Pratschke, J, Pinna, A, Hauss, J, Schreiber, S, Strasser, S, Klempnauer, J, Troisi, R, Bhoori, S, Lerut, J, Bilbao, I, Klein, C, Konigsrainer, A, Otto, G, Mazzaferro, V, Neuhaus, P, Renner P., Da Silva T., Schnitzbauer A. A., Verloh N., Schlitt H. J., Geissler E. K., Zulke C., Lamby P. E., Proneth A., Duvoux C., Burra P., Jauch K. -W., Rentsch M., Ganten T. M., Schmidt J., Settmacher U., Heise M., Rossi G., Cillo U., Kneteman N., Adam R., Van Hoek B., Bachellier P., Wolf P., Rostaing L., Bechstein W. O., Rizell M., Powell J., Hidalgo E., Gugenheim J., Wolters H., Brockmann J., Roy A., Mutzbauer I., Schlitt A., Beckebaum S., Graeb C., Nadalin S., Valente U., Sanchez Turrion V., Jamieson N., Scholz T., Colledan M., Fandrich F., Becker T., Soderdahl G., Chazouilleres O., Makisalo H., Pageaux G. -P., Steininger R., Soliman T., De Jong K. P., Pirenne J., Margreiter R., Pratschke J., Pinna A. D., Hauss J., Schreiber S., Strasser S., Klempnauer J., Troisi R. I., Bhoori S., Lerut J., Bilbao I., Klein C. G., Konigsrainer A., Otto G., Mazzaferro V., and Neuhaus P.

Abstract

Background: Recipient selection for liver transplantation in hepatocellular carcinoma (HCC) is based primarily on criteria affecting the chance of long-term success. Here, the relationship between pretransplant bridging therapy and long-term survival was investigated in a subgroup analysis of the SiLVER Study. Methods: Response to bridging, as defined by comparison of imaging at the time of listing and post-transplant pathology report, was categorized into controlled versus progressive disease (more than 20 per cent tumour growth or development of new lesions). Results: Of 525 patients with HCC who had liver transplantation, 350 recipients underwent pretransplant bridging therapy. Tumour progression despite bridging was an independent risk factor affecting overall survival (hazard ratio 1.80; P=0.005). For patients within the Milan criteria (MC) at listing, mean overall survival was longer for those with controlled versus progressive disease (6.8 versus 5.8 years; P<0.001). Importantly, patients with HCCs outside the MC that were downsized to within the MC before liver transplantation had poor outcomes compared with patients who never exceeded the MC (mean overall survival 6.2 versus 6.6 years respectively; P=0.030). Conclusion: Patients with HCCs within the MC that did not show tumour progression under locoregional therapy had the best outcomes after liver transplantation. Downstaging into the limits of the MC did not improve the probability of survival. Prognostic factors determining the long-term success of liver transplantation in patients with hepatocellular carcinoma are still under discussion. A subgroup analysis of the SiLVER trial showed that disease control under bridging therapy is strongly associated with improved prognosis in terms of overall survival. However, in tumours exceeding the limits of the Milan criteria, downstaging did not restore the probability of survival compared with that of patients within the Milan criteria.

Published
2021

32. Hepatocellular carcinoma progression during bridging before liver transplantation

Author

Renner P., Da Silva T., Schnitzbauer A. A., Verloh N., Schlitt H. J., Geissler E. K., Zulke C., Lamby P. E., Proneth A., Duvoux C., Burra P., Jauch K. -W., Rentsch M., Ganten T. M., Schmidt J., Settmacher U., Heise M., Rossi G., Cillo U., Kneteman N., Adam R., Van Hoek B., Bachellier P., Wolf P., Rostaing L., Bechstein W. O., Rizell M., Powell J., Hidalgo E., Gugenheim J., Wolters H., Brockmann J., Roy A., Mutzbauer I., Schlitt A., Beckebaum S., Graeb C., Nadalin S., Valente U., Sanchez Turrion V., Jamieson N., Scholz T., Colledan M., Fandrich F., Becker T., Soderdahl G., Chazouilleres O., Makisalo H., Pageaux G. -P., Steininger R., Soliman T., De Jong K. P., Pirenne J., Margreiter R., Pratschke J., Pinna A. D., Hauss J., Schreiber S., Strasser S., Klempnauer J., Troisi R. I., Bhoori S., Lerut J., Bilbao I., Klein C. G., Konigsrainer A., Otto G., Mazzaferro V., Neuhaus P., Renner, P, Da Silva, T, Schnitzbauer, A, Verloh, N, Schlitt, H, Geissler, E, Zulke, C, Lamby, P, Proneth, A, Duvoux, C, Burra, P, Jauch, K, Rentsch, M, Ganten, T, Schmidt, J, Settmacher, U, Heise, M, Rossi, G, Cillo, U, Kneteman, N, Adam, R, Van Hoek, B, Bachellier, P, Wolf, P, Rostaing, L, Bechstein, W, Rizell, M, Powell, J, Hidalgo, E, Gugenheim, J, Wolters, H, Brockmann, J, Roy, A, Mutzbauer, I, Schlitt, A, Beckebaum, S, Graeb, C, Nadalin, S, Valente, U, Sanchez Turrion, V, Jamieson, N, Scholz, T, Colledan, M, Fandrich, F, Becker, T, Soderdahl, G, Chazouilleres, O, Makisalo, H, Pageaux, G, Steininger, R, Soliman, T, De Jong, K, Pirenne, J, Margreiter, R, Pratschke, J, Pinna, A, Hauss, J, Schreiber, S, Strasser, S, Klempnauer, J, Troisi, R, Bhoori, S, Lerut, J, Bilbao, I, Klein, C, Konigsrainer, A, Otto, G, Mazzaferro, V, Neuhaus, P, and Publica

Subjects
Male, Carcinoma, Hepatocellular, Time Factor, Waiting Lists, AcademicSubjects/MED00910, Prognosi, Risk Factor, Middle Aged, Liver Transplantation, Treatment Outcome, Liver Neoplasm, Disease Progression, Female, Original Article, Survival Analysi, Neoplasm Recurrence, Local, AcademicSubjects/MED00010, Multivariate Analysi, Human
Abstract

Background Recipient selection for liver transplantation in hepatocellular carcinoma (HCC) is based primarily on criteria affecting the chance of long-term success. Here, the relationship between pretransplant bridging therapy and long-term survival was investigated in a subgroup analysis of the SiLVER Study. Methods Response to bridging, as defined by comparison of imaging at the time of listing and post-transplant pathology report, was categorized into controlled versus progressive disease (more than 20 per cent tumour growth or development of new lesions). Results Of 525 patients with HCC who had liver transplantation, 350 recipients underwent pretransplant bridging therapy. Tumour progression despite bridging was an independent risk factor affecting overall survival (hazard ratio 1.80; P = 0.005). For patients within the Milan criteria (MC) at listing, mean overall survival was longer for those with controlled versus progressive disease (6.8 versus 5.8 years; P

Published
2021

37. mTOR Inhibition Is Most Beneficial After Liver Transplantation for Hepatocellular Carcinoma in Patients With Active Tumors

Author

Schnitzbauer, A, Filmann, N, Adam, R, Bachellier, P, Bechstein, W, Becker, T, Bhoori, S, Bilbao, I, Brockmann, J, Burra, P, Chazoullieres, O, Cillo, U, Colledan, M, Duvoux, C, Ganten, T, Gugenheim, J, Heise, M, van Hoek, B, Jamieson, N, de Jong, K, Klein, C, Klempnauer, J, Kneteman, N, Lerut, J, Makisalo, H, Mazzaferro, V, Mirza, D, Nadalin, S, Neuhaus, P, Pageaux, G, Pinna, A, Pirenne, J, Pratschke, J, Powel, J, Rentsch, M, Rizell, M, Rossi, G, Rostaing, L, Roy, A, Scholz, T, Settmacher, U, Soliman, T, Strasser, S, Soderdahl, G, Troisi, R, Turrion, V, Schlitt, H, Geissler, E, Schnitzbauer AA, Filmann N, Adam RP, Bachellier P, Bechstein WO, Becker T, Bhoori S, Bilbao I, Brockmann J, Burra P, Chazoullieres O, Cillo U, Colledan M, Duvoux C, Ganten TM, Gugenheim J, Heise M, van Hoek B, Jamieson N, de Jong KP, Klein CG, Klempnauer J, Kneteman N, Lerut J, Makisalo H, Mazzaferro V, Mirza DF, Nadalin S, Neuhaus P, Pageaux GP, Pinna AD, Pirenne J, Pratschke J, Powel J, Rentsch M, Rizell M, Rossi G, Rostaing L, Roy AP, Scholz T, Settmacher U, Soliman T, Strasser S, Soderdahl G, Troisi RI, Turrion VS, Schlitt HJ, Geissler EK, Schnitzbauer, A, Filmann, N, Adam, R, Bachellier, P, Bechstein, W, Becker, T, Bhoori, S, Bilbao, I, Brockmann, J, Burra, P, Chazoullieres, O, Cillo, U, Colledan, M, Duvoux, C, Ganten, T, Gugenheim, J, Heise, M, van Hoek, B, Jamieson, N, de Jong, K, Klein, C, Klempnauer, J, Kneteman, N, Lerut, J, Makisalo, H, Mazzaferro, V, Mirza, D, Nadalin, S, Neuhaus, P, Pageaux, G, Pinna, A, Pirenne, J, Pratschke, J, Powel, J, Rentsch, M, Rizell, M, Rossi, G, Rostaing, L, Roy, A, Scholz, T, Settmacher, U, Soliman, T, Strasser, S, Soderdahl, G, Troisi, R, Turrion, V, Schlitt, H, Geissler, E, Schnitzbauer AA, Filmann N, Adam RP, Bachellier P, Bechstein WO, Becker T, Bhoori S, Bilbao I, Brockmann J, Burra P, Chazoullieres O, Cillo U, Colledan M, Duvoux C, Ganten TM, Gugenheim J, Heise M, van Hoek B, Jamieson N, de Jong KP, Klein CG, Klempnauer J, Kneteman N, Lerut J, Makisalo H, Mazzaferro V, Mirza DF, Nadalin S, Neuhaus P, Pageaux GP, Pinna AD, Pirenne J, Pratschke J, Powel J, Rentsch M, Rizell M, Rossi G, Rostaing L, Roy AP, Scholz T, Settmacher U, Soliman T, Strasser S, Soderdahl G, Troisi RI, Turrion VS, Schlitt HJ, and Geissler EK

Abstract

Objective: The aim of this study was to evaluate the survival benefit of sirolimus in patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC) (exploratory analysis of the SiLVER-trial). Summary and Background Data: Patients receiving LT) for HCC are at a high risk for tumor recurrence. Calcineurin inhibitors have shown evidence to promote cancer growth, whereas mammalian target of rapamycin (mTOR) inhibitors like sirolimus have anticancer effects. In the SiLVER-trial (Clinicaltrials.gov:NCT00355862), the effect of sirolimus on the recurrence of HCC after LTwas investigated in a prospective randomized trial. Although the primary endpoint of improved disease-free survival (DFS) with sirolimus was not met, outcomes were improved for patients in the sirolimus-treatment arm in the first 3 to 5 years. To learn more about the key variables, a multivariate analysis was performed on the SiLVER-trial data. Patients and Methods: Data from 508 patients of the intention-to-treat analysis were included in exploratory univariate and multivariate models for overall survival (OS), DFS and a competing risk analysis for HCC recurrence. Results: Sirolimus use for >= 3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52-0.96, P = 0.02). Most strikingly, patients with an alpha-fetoprotein (AFP) >= 10 ng/mL and having used sirolimus for >= 3 months, benefited most with regard to OS, DFS, and HCC-recurrence (HR: 0.49- 0.59, P = 0.0079- 0.0245). Conclusions: mTOR-inhibitor treatment with sirolimus for >= 3 months improves outcomes in LT for HCC, especially in patients with AFP-evidence of higher tumor activity, advocating particularly for mTOR inhibitor use in this subgroup of patients. Clinical Trial Registration: EudraCT: 2005-005362-36 Clinicaltrials.gov: NCT00355862.

Published
2020

38. HCC recurrence in HCV-infected patients after liver transplantation: SiLVER Study reveals benefits of sirolimus in combination with CNIs – a post-hoc analysis

Author

Werner, J, Hornung, M, Krah, R, Gotz, M, Schnitzbauer, A, Schlitt, H, Geissler, E, Zulke, C, Lamby, P, Proneth, A, Duvoux, C, Burra, P, Jauch, K, Rentsch, M, Ganten, T, Schmidt, J, Settmacher, U, Heise, M, Rossi, G, Cillo, U, Kneteman, N, Adam, R, Hoek, B, Bachellier, P, Wolf, P, Rostaing, L, Bechstein, W, Rizell, M, Powell, J, Hidalgo, E, Gugenheim, J, Wolters, H, Brockmann, J, Roy, A, Mutzbauer, I, Schlitt, A, Beckebaum, S, Graeb, C, Nadalin, S, Valente, U, Turrion, V, Jamieson, N, Scholz, T, Colledan, M, Fandrich, F, Becker, T, Soderdahl, G, Chazouilleres, O, Makisalo, H, Pageaux, G, Steininger, R, Soliman, T, Jong, K, Pirenne, J, Margreiter, R, Pratschke, J, Pinna, A, Hauss, J, Schreiber, S, Strasser, S, Klempnauer, J, Troisi, R, Bhoori, S, Lerut, J, Bilbao, I, Klein, C, Konigsrainer, A, Otto, G, Mazzaferro, V, Neuhaus, P, Werner J. M., Hornung M., Krah R., Gotz M., Schnitzbauer A. A., Schlitt H. J., Geissler E. K., Zulke C., Lamby P. E., Proneth A., Duvoux C., Burra P., Jauch K. -W., Rentsch M., Ganten T. M., Schmidt J., Settmacher U., Heise M., Rossi G., Cillo U., Kneteman N., Adam R., Hoek B., Bachellier P., Wolf P., Rostaing L., Bechstein W. O., Rizell M., Powell J., Hidalgo E., Gugenheim J., Wolters H., Brockmann J., Roy A., Mutzbauer I., Schlitt A., Beckebaum S., Graeb C., Nadalin S., Valente U., Turrion V. S., Jamieson N., Scholz T., Colledan M., Fandrich F., Becker T., Soderdahl G., Chazouilleres O., Makisalo H., Pageaux G. -P., Steininger R., Soliman T., Jong K. P., Pirenne J., Margreiter R., Pratschke J., Pinna A. D., Hauss J., Schreiber S., Strasser S., Klempnauer J., Troisi R. I., Bhoori S., Lerut J., Bilbao I., Klein C. G., Konigsrainer A., Otto G., Mazzaferro V., Neuhaus P., Werner, J, Hornung, M, Krah, R, Gotz, M, Schnitzbauer, A, Schlitt, H, Geissler, E, Zulke, C, Lamby, P, Proneth, A, Duvoux, C, Burra, P, Jauch, K, Rentsch, M, Ganten, T, Schmidt, J, Settmacher, U, Heise, M, Rossi, G, Cillo, U, Kneteman, N, Adam, R, Hoek, B, Bachellier, P, Wolf, P, Rostaing, L, Bechstein, W, Rizell, M, Powell, J, Hidalgo, E, Gugenheim, J, Wolters, H, Brockmann, J, Roy, A, Mutzbauer, I, Schlitt, A, Beckebaum, S, Graeb, C, Nadalin, S, Valente, U, Turrion, V, Jamieson, N, Scholz, T, Colledan, M, Fandrich, F, Becker, T, Soderdahl, G, Chazouilleres, O, Makisalo, H, Pageaux, G, Steininger, R, Soliman, T, Jong, K, Pirenne, J, Margreiter, R, Pratschke, J, Pinna, A, Hauss, J, Schreiber, S, Strasser, S, Klempnauer, J, Troisi, R, Bhoori, S, Lerut, J, Bilbao, I, Klein, C, Konigsrainer, A, Otto, G, Mazzaferro, V, Neuhaus, P, Werner J. M., Hornung M., Krah R., Gotz M., Schnitzbauer A. A., Schlitt H. J., Geissler E. K., Zulke C., Lamby P. E., Proneth A., Duvoux C., Burra P., Jauch K. -W., Rentsch M., Ganten T. M., Schmidt J., Settmacher U., Heise M., Rossi G., Cillo U., Kneteman N., Adam R., Hoek B., Bachellier P., Wolf P., Rostaing L., Bechstein W. O., Rizell M., Powell J., Hidalgo E., Gugenheim J., Wolters H., Brockmann J., Roy A., Mutzbauer I., Schlitt A., Beckebaum S., Graeb C., Nadalin S., Valente U., Turrion V. S., Jamieson N., Scholz T., Colledan M., Fandrich F., Becker T., Soderdahl G., Chazouilleres O., Makisalo H., Pageaux G. -P., Steininger R., Soliman T., Jong K. P., Pirenne J., Margreiter R., Pratschke J., Pinna A. D., Hauss J., Schreiber S., Strasser S., Klempnauer J., Troisi R. I., Bhoori S., Lerut J., Bilbao I., Klein C. G., Konigsrainer A., Otto G., Mazzaferro V., and Neuhaus P.

Abstract

Factors affecting outcomes in liver transplant (LTx) recipients with hepatocellular carcinoma (HCC) and hepatitis C viral (HCV) infection include the choice of immunosuppression. Here, we analyzed the HCV+ subgroup of patients from the randomized controlled, international SiLVER Study. We performed a post hoc analysis of 166 HCV+ SiLVER Study patients regarding HCC outcome after LTx. Control patients (group A: n = 88) received mTOR inhibitor (mTORi)-free, calcineurin inhibitor (CNI)-based versus sirolimus-based immunosuppression (group B: n = 78). We found no significant difference regarding HCV-RNA titers between group A and B. Since no effect in group B could be due to variable sirolimus dosing, we split group B into patients receiving sirolimus-based immunosuppression + CNIs for >50% (B1; n = 44) or <50% (B2; n = 34) of the time. While there remained no difference in HCV-RNA titer between groups, HCC recurrence-free survival in group B1 (81.8%) was markedly better versus both group A (62.7%; P = 0.0136) and group B2 (64.7%; P = 0.0326); Interestingly, further subgroup analysis revealed an increase (P = 0.0012) in liver enzyme values in group B2. Taken together, in HCV-infected patients with HCC and LTx, mTORi immunosuppression + CNIs yields excellent outcomes. Unexpectedly, higher levels of liver inflammation and poorer outcomes occur with mTORi monotherapy in the HCV+ subgroup.

Published
2020

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