The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes

Paola Carrai, Cristina Morelli, Gabriella Cordone, Antonietta Romano, Mariarosa Tamé, Raffaella Lionetti, Giada Pietrosi, Ilaria Lenci, Guido Piai, Francesco Paolo Russo, Carmine Coppola, Mario Melazzini, Simona Montilla, Luca Pani, Sandra Petraglia, Pierluigi Russo, Maria Paola Trotta, Silvia Martini, Pierluigi Toniutto, Francesco BandieraSherrie Bhoori, Stefano Brillanti, Patrizia Burra, Sveva Corsale, Andrea De Luca, Stefano Fagiuoli, Giovanna Fattovich, Gianmarco Fava, Martina Felder, Paolo Forte, Alfonso Galeota-Lanza, Stefano Gitto, Paolo Grossi, Paolo Grossi, A. M. Ialungo, Rosa Maria Iemmolo, Laura Loiacono, Alessandra Mangia, Manuela Merli, A. Piacentini, Adriano Pellicelli, Cristina Rigamonti, Verucchi Gabriella, Anna Linda Zignego, the ITACOPS study group

Research output: Contribution to journalArticle

Abstract

Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3–F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child–Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child–Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score <15, a significant association was found between maintaining a final MELD score <15 and the achievement of SVR (187/219 vs. 6/10, P = 0.031). This real-world study indicates that sofosbuvir/ribavirin treatment for 24 weeks was effective, and the achievement of SVR was associated with a reduced probability of developing worsening liver function.

Original languageEnglish
Pages (from-to)1253-1265
Number of pages13
JournalTransplant International
Volume30
Issue number12
DOIs
Publication statusPublished - Dec 1 2017

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Compassionate Use Trials
Hepatitis C
Observational Studies
Cohort Studies
Ribavirin
End Stage Liver Disease
Therapeutics
Antiviral Agents
Sofosbuvir
Hepatitis
Recurrence
Liver

Keywords

  • cholestatic hepatitis
  • hepatitis C
  • liver transplantation
  • sofosbuvir

ASJC Scopus subject areas

  • Transplantation

Cite this

The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C : clinical and virological outcomes. / Carrai, Paola; Morelli, Cristina; Cordone, Gabriella; Romano, Antonietta; Tamé, Mariarosa; Lionetti, Raffaella; Pietrosi, Giada; Lenci, Ilaria; Piai, Guido; Russo, Francesco Paolo; Coppola, Carmine; Melazzini, Mario; Montilla, Simona; Pani, Luca; Petraglia, Sandra; Russo, Pierluigi; Trotta, Maria Paola; Martini, Silvia; Toniutto, Pierluigi; Bandiera, Francesco; Bhoori, Sherrie; Brillanti, Stefano; Burra, Patrizia; Corsale, Sveva; De Luca, Andrea; Fagiuoli, Stefano; Fattovich, Giovanna; Fava, Gianmarco; Felder, Martina; Forte, Paolo; Galeota-Lanza, Alfonso; Gitto, Stefano; Grossi, Paolo; Grossi, Paolo; Ialungo, A. M.; Iemmolo, Rosa Maria; Loiacono, Laura; Mangia, Alessandra; Merli, Manuela; Piacentini, A.; Pellicelli, Adriano; Rigamonti, Cristina; Gabriella, Verucchi; Zignego, Anna Linda; the ITACOPS study group.

In: Transplant International, Vol. 30, No. 12, 01.12.2017, p. 1253-1265.

Research output: Contribution to journalArticle

Carrai, P, Morelli, C, Cordone, G, Romano, A, Tamé, M, Lionetti, R, Pietrosi, G, Lenci, I, Piai, G, Russo, FP, Coppola, C, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, MP, Martini, S, Toniutto, P, Bandiera, F, Bhoori, S, Brillanti, S, Burra, P, Corsale, S, De Luca, A, Fagiuoli, S, Fattovich, G, Fava, G, Felder, M, Forte, P, Galeota-Lanza, A, Gitto, S, Grossi, P, Grossi, P, Ialungo, AM, Iemmolo, RM, Loiacono, L, Mangia, A, Merli, M, Piacentini, A, Pellicelli, A, Rigamonti, C, Gabriella, V, Zignego, AL & the ITACOPS study group 2017, 'The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes', Transplant International, vol. 30, no. 12, pp. 1253-1265. https://doi.org/10.1111/tri.13018
Carrai, Paola ; Morelli, Cristina ; Cordone, Gabriella ; Romano, Antonietta ; Tamé, Mariarosa ; Lionetti, Raffaella ; Pietrosi, Giada ; Lenci, Ilaria ; Piai, Guido ; Russo, Francesco Paolo ; Coppola, Carmine ; Melazzini, Mario ; Montilla, Simona ; Pani, Luca ; Petraglia, Sandra ; Russo, Pierluigi ; Trotta, Maria Paola ; Martini, Silvia ; Toniutto, Pierluigi ; Bandiera, Francesco ; Bhoori, Sherrie ; Brillanti, Stefano ; Burra, Patrizia ; Corsale, Sveva ; De Luca, Andrea ; Fagiuoli, Stefano ; Fattovich, Giovanna ; Fava, Gianmarco ; Felder, Martina ; Forte, Paolo ; Galeota-Lanza, Alfonso ; Gitto, Stefano ; Grossi, Paolo ; Grossi, Paolo ; Ialungo, A. M. ; Iemmolo, Rosa Maria ; Loiacono, Laura ; Mangia, Alessandra ; Merli, Manuela ; Piacentini, A. ; Pellicelli, Adriano ; Rigamonti, Cristina ; Gabriella, Verucchi ; Zignego, Anna Linda ; the ITACOPS study group. / The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C : clinical and virological outcomes. In: Transplant International. 2017 ; Vol. 30, No. 12. pp. 1253-1265.
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T1 - The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C

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AU - Carrai, Paola

AU - Morelli, Cristina

AU - Cordone, Gabriella

AU - Romano, Antonietta

AU - Tamé, Mariarosa

AU - Lionetti, Raffaella

AU - Pietrosi, Giada

AU - Lenci, Ilaria

AU - Piai, Guido

AU - Russo, Francesco Paolo

AU - Coppola, Carmine

AU - Melazzini, Mario

AU - Montilla, Simona

AU - Pani, Luca

AU - Petraglia, Sandra

AU - Russo, Pierluigi

AU - Trotta, Maria Paola

AU - Martini, Silvia

AU - Toniutto, Pierluigi

AU - Bandiera, Francesco

AU - Bhoori, Sherrie

AU - Brillanti, Stefano

AU - Burra, Patrizia

AU - Corsale, Sveva

AU - De Luca, Andrea

AU - Fagiuoli, Stefano

AU - Fattovich, Giovanna

AU - Fava, Gianmarco

AU - Felder, Martina

AU - Forte, Paolo

AU - Galeota-Lanza, Alfonso

AU - Gitto, Stefano

AU - Grossi, Paolo

AU - Grossi, Paolo

AU - Ialungo, A. M.

AU - Iemmolo, Rosa Maria

AU - Loiacono, Laura

AU - Mangia, Alessandra

AU - Merli, Manuela

AU - Piacentini, A.

AU - Pellicelli, Adriano

AU - Rigamonti, Cristina

AU - Gabriella, Verucchi

AU - Zignego, Anna Linda

AU - the ITACOPS study group

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KW - hepatitis C

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