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, ITACOPS study group

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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 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

  • Journal Article

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; ITACOPS study group.

In: Transplant International, Vol. 30, No. 12, 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 & 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 ; 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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AU - Tamé, Mariarosa

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AU - Pietrosi, Giada

AU - Lenci, Ilaria

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AU - Russo, Francesco Paolo

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AU - Montilla, Simona

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AU - Petraglia, Sandra

AU - Russo, Pierluigi

AU - Trotta, Maria Paola

AU - Martini, Silvia

AU - Toniutto, Pierluigi

AU - ITACOPS study group

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