A Randomized Multicenter Study Comparing a Tacrolimus-Based Protocol with and without Steroids in HCV-Positive Liver Allograft Recipients
Allograft reinfection with hepatitis C virus (HCV) occurs universally in liver transplant recipients. Corticosteroids can contribute to HCV recurrence. This randomized study evaluated HCV recurrence in HCV-positive liver allograft recipients using steroid-free immunosuppression. All patients receive...
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| Format: | Article |
| Language: | English |
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Wiley
2012-01-01
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| Series: | Journal of Transplantation |
| Online Access: | http://dx.doi.org/10.1155/2012/894215 |
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| author | Ulf Neumann Didier Samuel Pavel Trunečka Jean Gugenheim Giorgio Enrico Gerunda Styrbjörn Friman |
| author_facet | Ulf Neumann Didier Samuel Pavel Trunečka Jean Gugenheim Giorgio Enrico Gerunda Styrbjörn Friman |
| author_sort | Ulf Neumann |
| collection | DOAJ |
| description | Allograft reinfection with hepatitis C virus (HCV) occurs universally in liver transplant recipients. Corticosteroids can contribute to HCV recurrence.
This randomized study evaluated HCV recurrence in HCV-positive liver allograft recipients using steroid-free immunosuppression. All patients received tacrolimus (TAC) at an initial dose of 0.10–0.15 mg/kg. The steroid-free arm (TAC/daclizumab (TAC/DAC, n=67)) received daclizumab induction, and the steroid arm (TAC/steroid (TAC/STR, n=68)) received a steroid bolus (≤ 500mg) followed by 15–20 mg/day with discontinuation after month 3. Median HCV viral load at month 12, the primary endpoint, was similar at 5.46 (0.95–6.54) IU/mL with TAC/DAC and 5.91 (0.95–6.89) IU/mL with TAC/STR. Small numerical differences in the estimated rate of freedom from HCV recurrence (19.1 versus 13.8%) and freedom from biopsy proven rejection (78.4 versus 66.1%) were observed between TAC/DAC and TAC/STR. Patient survival estimates were significantly lower with TAC/DAC than with TAC/STR (83.1 versus 95.5%; 95% CI, −0.227 to −0.019%), and graft survival was numerically lower (80.1 versus 91.1%, P=NS). Completion rates (45 versus 82%) indicated poorer tolerability with TAC/DAC than with TAC/STR. Steroid-free immunosuppression had no real impact on HCV viral load. HCV recurrence was higher with TAC/STR. Results are inconclusive due to the unexpected lower completion rates in the TAC/DAC arm. |
| format | Article |
| id | doaj-art-5271c6528e01479a8938ddcb4b57f79c |
| institution | Kabale University |
| issn | 2090-0007 2090-0015 |
| language | English |
| publishDate | 2012-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Transplantation |
| spelling | doaj-art-5271c6528e01479a8938ddcb4b57f79c2025-02-03T01:24:28ZengWileyJournal of Transplantation2090-00072090-00152012-01-01201210.1155/2012/894215894215A Randomized Multicenter Study Comparing a Tacrolimus-Based Protocol with and without Steroids in HCV-Positive Liver Allograft RecipientsUlf Neumann0Didier Samuel1Pavel Trunečka2Jean Gugenheim3Giorgio Enrico Gerunda4Styrbjörn Friman5Department of General, Visceral and Transplantation Surgery, Charité, Campus Virchow Clinic, 13353 Berlin, GermanyCentre Hépato-Billaire, Hôpital Paul Brousse, 94804 Villejuif, FranceDepartment of Hepatogastroenterology, IKEM, 140 21 Praha, Czech RepublicService de Chirurgie Générale et Digestive, Hopital l’Archetet II, 6000 Nice, FranceCentro Trapianti Multiviscerale, di Fegato e di Chirurgia Epatobiliopancreatica, Azienda Ospedaliero Universitaria di Modena, 40124 Modena, ItalyTransplant Institute, Sahlgrenska University Hospital, 413 45 Göteborg, SwedenAllograft reinfection with hepatitis C virus (HCV) occurs universally in liver transplant recipients. Corticosteroids can contribute to HCV recurrence. This randomized study evaluated HCV recurrence in HCV-positive liver allograft recipients using steroid-free immunosuppression. All patients received tacrolimus (TAC) at an initial dose of 0.10–0.15 mg/kg. The steroid-free arm (TAC/daclizumab (TAC/DAC, n=67)) received daclizumab induction, and the steroid arm (TAC/steroid (TAC/STR, n=68)) received a steroid bolus (≤ 500mg) followed by 15–20 mg/day with discontinuation after month 3. Median HCV viral load at month 12, the primary endpoint, was similar at 5.46 (0.95–6.54) IU/mL with TAC/DAC and 5.91 (0.95–6.89) IU/mL with TAC/STR. Small numerical differences in the estimated rate of freedom from HCV recurrence (19.1 versus 13.8%) and freedom from biopsy proven rejection (78.4 versus 66.1%) were observed between TAC/DAC and TAC/STR. Patient survival estimates were significantly lower with TAC/DAC than with TAC/STR (83.1 versus 95.5%; 95% CI, −0.227 to −0.019%), and graft survival was numerically lower (80.1 versus 91.1%, P=NS). Completion rates (45 versus 82%) indicated poorer tolerability with TAC/DAC than with TAC/STR. Steroid-free immunosuppression had no real impact on HCV viral load. HCV recurrence was higher with TAC/STR. Results are inconclusive due to the unexpected lower completion rates in the TAC/DAC arm.http://dx.doi.org/10.1155/2012/894215 |
| spellingShingle | Ulf Neumann Didier Samuel Pavel Trunečka Jean Gugenheim Giorgio Enrico Gerunda Styrbjörn Friman A Randomized Multicenter Study Comparing a Tacrolimus-Based Protocol with and without Steroids in HCV-Positive Liver Allograft Recipients Journal of Transplantation |
| title | A Randomized Multicenter Study Comparing a Tacrolimus-Based Protocol with and without Steroids in HCV-Positive Liver Allograft Recipients |
| title_full | A Randomized Multicenter Study Comparing a Tacrolimus-Based Protocol with and without Steroids in HCV-Positive Liver Allograft Recipients |
| title_fullStr | A Randomized Multicenter Study Comparing a Tacrolimus-Based Protocol with and without Steroids in HCV-Positive Liver Allograft Recipients |
| title_full_unstemmed | A Randomized Multicenter Study Comparing a Tacrolimus-Based Protocol with and without Steroids in HCV-Positive Liver Allograft Recipients |
| title_short | A Randomized Multicenter Study Comparing a Tacrolimus-Based Protocol with and without Steroids in HCV-Positive Liver Allograft Recipients |
| title_sort | randomized multicenter study comparing a tacrolimus based protocol with and without steroids in hcv positive liver allograft recipients |
| url | http://dx.doi.org/10.1155/2012/894215 |
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