A randomized study on Peg-interferon alfa-2a with or without ribavirin in liver transplant recipients with recurrent hepatitis C

Mario Angelico, Alessandra Petrolati, Raffaella Lionetti, Ilaria Lenci, Patrizia Burra, Maria Francesca Donato, Manuela Merli, Mario Strazzabosco, Giuseppe Tisone

Research output: Contribution to journalArticle

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Abstract

Background/Aims: We performed a randomized trial on pegylated interferon alfa-2a (Peg-IFNα) monotherapy vs Peg-IFNα and ribavirin in non-cirrhotic liver transplant recipients with recurrent hepatitis C. Methods: Forty-two patients transplanted for HCV-related cirrhosis 12-96 months earlier were randomized to Peg-IFNα monotherapy (180 μg weekly) or Peg-IFNα and ribavirin, up to the maximum tolerated dose, for 48 weeks. Results: Early virological response (EVR, i.e., HCV-RNA ≥ 2 log drop at week 12) occurred in 76% of the monotherapy and 71% of the combination groups, respectively (intention-to treat). Sustained virological response (SVR) occurred in 8 (38%) and 7 (33%) patients, respectively. EVR had a positive predictive value for SVR of 50% and 47%, respectively, and a 100% negative predictive value in both groups. Six drop-outs occurred in the monotherapy (including 3 rejections) and 7 in the combination groups (including one rejection). Peg-INFα dose was reduced in 7 and 8 patients, respectively. The average daily dose of ribavirin was 435 mg/day. Conclusions: Peg-IFNα-2a, with or without ribavirin, induces SVR in one-third of transplant recipients with recurrent hepatitis C. Treatment cessation is indicated in patients without EVR. The low SVR rate is mainly due to inability to sustain full doses of antivirals and lack of the booster effect of ribavirin.

Original languageEnglish
Pages (from-to)1009-1017
Number of pages9
JournalJournal of Hepatology
Volume46
Issue number6
DOIs
Publication statusPublished - Jun 2007

Fingerprint

Ribavirin
Hepatitis C
Liver
Withholding Treatment
Maximum Tolerated Dose
Antiviral Agents
Fibrosis
interferon alfa-2a
peginterferon alfa-2a
Transplant Recipients
RNA
Rejection (Psychology)

Keywords

  • HCV
  • Liver transplantation
  • Peginterferon alfa-2a
  • Ribavirin
  • Treatment

ASJC Scopus subject areas

  • Gastroenterology

Cite this

A randomized study on Peg-interferon alfa-2a with or without ribavirin in liver transplant recipients with recurrent hepatitis C. / Angelico, Mario; Petrolati, Alessandra; Lionetti, Raffaella; Lenci, Ilaria; Burra, Patrizia; Donato, Maria Francesca; Merli, Manuela; Strazzabosco, Mario; Tisone, Giuseppe.

In: Journal of Hepatology, Vol. 46, No. 6, 06.2007, p. 1009-1017.

Research output: Contribution to journalArticle

Angelico, Mario ; Petrolati, Alessandra ; Lionetti, Raffaella ; Lenci, Ilaria ; Burra, Patrizia ; Donato, Maria Francesca ; Merli, Manuela ; Strazzabosco, Mario ; Tisone, Giuseppe. / A randomized study on Peg-interferon alfa-2a with or without ribavirin in liver transplant recipients with recurrent hepatitis C. In: Journal of Hepatology. 2007 ; Vol. 46, No. 6. pp. 1009-1017.
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AU - Angelico, Mario

AU - Petrolati, Alessandra

AU - Lionetti, Raffaella

AU - Lenci, Ilaria

AU - Burra, Patrizia

AU - Donato, Maria Francesca

AU - Merli, Manuela

AU - Strazzabosco, Mario

AU - Tisone, Giuseppe

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N2 - Background/Aims: We performed a randomized trial on pegylated interferon alfa-2a (Peg-IFNα) monotherapy vs Peg-IFNα and ribavirin in non-cirrhotic liver transplant recipients with recurrent hepatitis C. Methods: Forty-two patients transplanted for HCV-related cirrhosis 12-96 months earlier were randomized to Peg-IFNα monotherapy (180 μg weekly) or Peg-IFNα and ribavirin, up to the maximum tolerated dose, for 48 weeks. Results: Early virological response (EVR, i.e., HCV-RNA ≥ 2 log drop at week 12) occurred in 76% of the monotherapy and 71% of the combination groups, respectively (intention-to treat). Sustained virological response (SVR) occurred in 8 (38%) and 7 (33%) patients, respectively. EVR had a positive predictive value for SVR of 50% and 47%, respectively, and a 100% negative predictive value in both groups. Six drop-outs occurred in the monotherapy (including 3 rejections) and 7 in the combination groups (including one rejection). Peg-INFα dose was reduced in 7 and 8 patients, respectively. The average daily dose of ribavirin was 435 mg/day. Conclusions: Peg-IFNα-2a, with or without ribavirin, induces SVR in one-third of transplant recipients with recurrent hepatitis C. Treatment cessation is indicated in patients without EVR. The low SVR rate is mainly due to inability to sustain full doses of antivirals and lack of the booster effect of ribavirin.

AB - Background/Aims: We performed a randomized trial on pegylated interferon alfa-2a (Peg-IFNα) monotherapy vs Peg-IFNα and ribavirin in non-cirrhotic liver transplant recipients with recurrent hepatitis C. Methods: Forty-two patients transplanted for HCV-related cirrhosis 12-96 months earlier were randomized to Peg-IFNα monotherapy (180 μg weekly) or Peg-IFNα and ribavirin, up to the maximum tolerated dose, for 48 weeks. Results: Early virological response (EVR, i.e., HCV-RNA ≥ 2 log drop at week 12) occurred in 76% of the monotherapy and 71% of the combination groups, respectively (intention-to treat). Sustained virological response (SVR) occurred in 8 (38%) and 7 (33%) patients, respectively. EVR had a positive predictive value for SVR of 50% and 47%, respectively, and a 100% negative predictive value in both groups. Six drop-outs occurred in the monotherapy (including 3 rejections) and 7 in the combination groups (including one rejection). Peg-INFα dose was reduced in 7 and 8 patients, respectively. The average daily dose of ribavirin was 435 mg/day. Conclusions: Peg-IFNα-2a, with or without ribavirin, induces SVR in one-third of transplant recipients with recurrent hepatitis C. Treatment cessation is indicated in patients without EVR. The low SVR rate is mainly due to inability to sustain full doses of antivirals and lack of the booster effect of ribavirin.

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