Peginterferon Alfa-2a for hepatitis C after liver transplantation: Two randomized, controlled trials

Naga Chalasani, Cosme Manzarbeitia, Peter Ferenci, Wolfgang Vogel, Robert J. Fontana, Michael Voigt, Caroline Riely, Paul Martin, Lewis Teperman, James Jiao, Juan Carlos Lopez-Talavera

Research output: Contribution to journalArticle

246 Citations (Scopus)

Abstract

There is currently no effective treatment for recurrent hepatitis C after orthotopic liver transplantation (OLT). We therefore performed two randomized, controlled trials - a prophylaxis trial and a treatment trial - to evaluate the safety and efficacy of peginterferon alfa-2a in patients who had undergone OLT. The prophylaxis trial enrolled 54 patients within 3 weeks after OLT, and the treatment trial enrolled 67 patients 6 to 60 months after OLT. In each trial, patients were randomized to treatment with once weekly injections of 180 μg peginterferon alfa-2a or no antiviral treatment for 48 weeks and were followed up for 24 weeks thereafter. Peginterferon alfa-2a treated patients had significantly lower hepatitis C virus RNA levels and more favorable changes in hepatic histological features compared with untreated controls. However, only 2 treated patients in the prophylaxis trial (8%) and 3 in the treatment trial (12%) achieved a sustained virological response. In the prophylaxis trial, 8 patients (31 %) in the peginterferon alfa-2a group and 9 (32%) in the untreated group were withdrawn prematurely; whereas in the treatment trial, 10 patients (30%) in the peginterferon alfa-2a group and 6 (19%) in the untreated group were withdrawn prematurely. The incidence of acute rejection was similar in the treated and untreated groups in both the prophylaxis (12% vs. 21%; P = .5) and treatment (12% vs. 0%; P = .1) trials. In conclusion, peginterferon alfa-2a treatment for 48 weeks is safe and tolerable and offers some efficacy in the post-OLT setting. Randomized controlled studies are needed to establish the efficacy of pegylated interferon and ribavirin in patients who have undergone OLT.

Original languageEnglish
Pages (from-to)289-298
Number of pages10
JournalHepatology
Volume41
Issue number2
DOIs
StatePublished - Feb 2005

Fingerprint

Hepatitis C
Liver Transplantation
Randomized Controlled Trials
Therapeutics
peginterferon alfa-2a
Ribavirin
Hepacivirus
Interferons
Antiviral Agents
RNA
Safety
Injections
Liver
Incidence

ASJC Scopus subject areas

  • Hepatology

Cite this

Chalasani, N., Manzarbeitia, C., Ferenci, P., Vogel, W., Fontana, R. J., Voigt, M., ... Lopez-Talavera, J. C. (2005). Peginterferon Alfa-2a for hepatitis C after liver transplantation: Two randomized, controlled trials. Hepatology, 41(2), 289-298. https://doi.org/10.1002/hep.20560

Peginterferon Alfa-2a for hepatitis C after liver transplantation : Two randomized, controlled trials. / Chalasani, Naga; Manzarbeitia, Cosme; Ferenci, Peter; Vogel, Wolfgang; Fontana, Robert J.; Voigt, Michael; Riely, Caroline; Martin, Paul; Teperman, Lewis; Jiao, James; Lopez-Talavera, Juan Carlos.

In: Hepatology, Vol. 41, No. 2, 02.2005, p. 289-298.

Research output: Contribution to journalArticle

Chalasani, N, Manzarbeitia, C, Ferenci, P, Vogel, W, Fontana, RJ, Voigt, M, Riely, C, Martin, P, Teperman, L, Jiao, J & Lopez-Talavera, JC 2005, 'Peginterferon Alfa-2a for hepatitis C after liver transplantation: Two randomized, controlled trials', Hepatology, vol. 41, no. 2, pp. 289-298. https://doi.org/10.1002/hep.20560
Chalasani, Naga ; Manzarbeitia, Cosme ; Ferenci, Peter ; Vogel, Wolfgang ; Fontana, Robert J. ; Voigt, Michael ; Riely, Caroline ; Martin, Paul ; Teperman, Lewis ; Jiao, James ; Lopez-Talavera, Juan Carlos. / Peginterferon Alfa-2a for hepatitis C after liver transplantation : Two randomized, controlled trials. In: Hepatology. 2005 ; Vol. 41, No. 2. pp. 289-298.
@article{0130804c4a284125af61e1a1487d9705,
title = "Peginterferon Alfa-2a for hepatitis C after liver transplantation: Two randomized, controlled trials",
abstract = "There is currently no effective treatment for recurrent hepatitis C after orthotopic liver transplantation (OLT). We therefore performed two randomized, controlled trials - a prophylaxis trial and a treatment trial - to evaluate the safety and efficacy of peginterferon alfa-2a in patients who had undergone OLT. The prophylaxis trial enrolled 54 patients within 3 weeks after OLT, and the treatment trial enrolled 67 patients 6 to 60 months after OLT. In each trial, patients were randomized to treatment with once weekly injections of 180 μg peginterferon alfa-2a or no antiviral treatment for 48 weeks and were followed up for 24 weeks thereafter. Peginterferon alfa-2a treated patients had significantly lower hepatitis C virus RNA levels and more favorable changes in hepatic histological features compared with untreated controls. However, only 2 treated patients in the prophylaxis trial (8{\%}) and 3 in the treatment trial (12{\%}) achieved a sustained virological response. In the prophylaxis trial, 8 patients (31 {\%}) in the peginterferon alfa-2a group and 9 (32{\%}) in the untreated group were withdrawn prematurely; whereas in the treatment trial, 10 patients (30{\%}) in the peginterferon alfa-2a group and 6 (19{\%}) in the untreated group were withdrawn prematurely. The incidence of acute rejection was similar in the treated and untreated groups in both the prophylaxis (12{\%} vs. 21{\%}; P = .5) and treatment (12{\%} vs. 0{\%}; P = .1) trials. In conclusion, peginterferon alfa-2a treatment for 48 weeks is safe and tolerable and offers some efficacy in the post-OLT setting. Randomized controlled studies are needed to establish the efficacy of pegylated interferon and ribavirin in patients who have undergone OLT.",
author = "Naga Chalasani and Cosme Manzarbeitia and Peter Ferenci and Wolfgang Vogel and Fontana, {Robert J.} and Michael Voigt and Caroline Riely and Paul Martin and Lewis Teperman and James Jiao and Lopez-Talavera, {Juan Carlos}",
year = "2005",
month = "2",
doi = "10.1002/hep.20560",
language = "English",
volume = "41",
pages = "289--298",
journal = "Hepatology",
issn = "0270-9139",
publisher = "John Wiley and Sons Ltd",
number = "2",

}

TY - JOUR

T1 - Peginterferon Alfa-2a for hepatitis C after liver transplantation

T2 - Two randomized, controlled trials

AU - Chalasani, Naga

AU - Manzarbeitia, Cosme

AU - Ferenci, Peter

AU - Vogel, Wolfgang

AU - Fontana, Robert J.

AU - Voigt, Michael

AU - Riely, Caroline

AU - Martin, Paul

AU - Teperman, Lewis

AU - Jiao, James

AU - Lopez-Talavera, Juan Carlos

PY - 2005/2

Y1 - 2005/2

N2 - There is currently no effective treatment for recurrent hepatitis C after orthotopic liver transplantation (OLT). We therefore performed two randomized, controlled trials - a prophylaxis trial and a treatment trial - to evaluate the safety and efficacy of peginterferon alfa-2a in patients who had undergone OLT. The prophylaxis trial enrolled 54 patients within 3 weeks after OLT, and the treatment trial enrolled 67 patients 6 to 60 months after OLT. In each trial, patients were randomized to treatment with once weekly injections of 180 μg peginterferon alfa-2a or no antiviral treatment for 48 weeks and were followed up for 24 weeks thereafter. Peginterferon alfa-2a treated patients had significantly lower hepatitis C virus RNA levels and more favorable changes in hepatic histological features compared with untreated controls. However, only 2 treated patients in the prophylaxis trial (8%) and 3 in the treatment trial (12%) achieved a sustained virological response. In the prophylaxis trial, 8 patients (31 %) in the peginterferon alfa-2a group and 9 (32%) in the untreated group were withdrawn prematurely; whereas in the treatment trial, 10 patients (30%) in the peginterferon alfa-2a group and 6 (19%) in the untreated group were withdrawn prematurely. The incidence of acute rejection was similar in the treated and untreated groups in both the prophylaxis (12% vs. 21%; P = .5) and treatment (12% vs. 0%; P = .1) trials. In conclusion, peginterferon alfa-2a treatment for 48 weeks is safe and tolerable and offers some efficacy in the post-OLT setting. Randomized controlled studies are needed to establish the efficacy of pegylated interferon and ribavirin in patients who have undergone OLT.

AB - There is currently no effective treatment for recurrent hepatitis C after orthotopic liver transplantation (OLT). We therefore performed two randomized, controlled trials - a prophylaxis trial and a treatment trial - to evaluate the safety and efficacy of peginterferon alfa-2a in patients who had undergone OLT. The prophylaxis trial enrolled 54 patients within 3 weeks after OLT, and the treatment trial enrolled 67 patients 6 to 60 months after OLT. In each trial, patients were randomized to treatment with once weekly injections of 180 μg peginterferon alfa-2a or no antiviral treatment for 48 weeks and were followed up for 24 weeks thereafter. Peginterferon alfa-2a treated patients had significantly lower hepatitis C virus RNA levels and more favorable changes in hepatic histological features compared with untreated controls. However, only 2 treated patients in the prophylaxis trial (8%) and 3 in the treatment trial (12%) achieved a sustained virological response. In the prophylaxis trial, 8 patients (31 %) in the peginterferon alfa-2a group and 9 (32%) in the untreated group were withdrawn prematurely; whereas in the treatment trial, 10 patients (30%) in the peginterferon alfa-2a group and 6 (19%) in the untreated group were withdrawn prematurely. The incidence of acute rejection was similar in the treated and untreated groups in both the prophylaxis (12% vs. 21%; P = .5) and treatment (12% vs. 0%; P = .1) trials. In conclusion, peginterferon alfa-2a treatment for 48 weeks is safe and tolerable and offers some efficacy in the post-OLT setting. Randomized controlled studies are needed to establish the efficacy of pegylated interferon and ribavirin in patients who have undergone OLT.

UR - http://www.scopus.com/inward/record.url?scp=19944430229&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=19944430229&partnerID=8YFLogxK

U2 - 10.1002/hep.20560

DO - 10.1002/hep.20560

M3 - Article

C2 - 15660392

AN - SCOPUS:19944430229

VL - 41

SP - 289

EP - 298

JO - Hepatology

JF - Hepatology

SN - 0270-9139

IS - 2

ER -