Long-term outcomes of direct acting antivirals in post-transplant advanced hepatitis C virus recurrence and fibrosing cholestatic hepatitis

R. Vukotic, F. Conti, S. Fagiuoli, M. C. Morelli, L. Pasulo, M. Colpani, F. G. Foschi, S. Berardi, P. Pianta, M. Mangano, M. F. Donato, F. Malinverno, S. Monico, M. Tamè, G. Mazzella, L. S. Belli, R. Viganò, P. Carrai, P. Burra, F. P. RussoI. Lenci, P. Toniutto, M. Merli, L. Loiacono, R. Iemmolo, A. M. Degli Antoni, A. Romano, A. Picciotto, M. Rendina, P. Andreone, AISF-SOFOLT Study group

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Long-term functional outcomes of sofosbuvir-based antiviral treatment were evaluated in a cohort study involving 16 Italian centres within the international compassionate use programme for post-transplant hepatitis C virus (HCV) recurrence. Seventy-three patients with cirrhosis (n=52) or fibrosing cholestatic hepatitis (FCH, n=21) received 24-week sofosbuvir with ribavirin±pegylated interferon or interferon-free sofosbuvir-based regimen with daclatasvir/simeprevir+ribavirin. The patients were observed for a median time of 103 (82-112) weeks. Twelve of 73 (16.4%) died (10 non-FCH, 2 FCH) and two underwent re-LT. Sustained virological response was achieved in 46 of 66 (69.7%): 31 of 47 (66%) non-FCH and 15 of 19 (79%) FCH patients. All relapsers were successfully retreated. Comparing the data of baseline with last follow-up, MELD and Child-Turcotte-Pugh scores improved both in non-FCH (15.3±6.5 vs 10.5±3.8, P<.0001 and 8.4±2.1 vs 5.7±1.3, P<.0001, respectively) and FCH (17.3±5.9 vs 10.1±2.8, P=.001 and 8.2±1.6 vs 5.5±1, P=.001, respectively). Short-treatment mortality was higher in patients with baseline MELD≥25 than in those with MELD<25 (42.9% vs 4.8%, P=.011). Long-term mortality was 53.3% among patients with baseline MELD≥20 and 7.5% among those with MELD<20 (P<.0001). Among deceased patients 75% were Child-Turcotte-Pugh class C at baseline, while among survivors 83.9% were class A or B (P<.0001). Direct acting antivirals-based treatments for severe post-transplant hepatitis C recurrence, comprising fibrosing cholestatic hepatitis, significantly improve liver function, even without viral clearance and permit an excellent long-term survival. The setting of severe HCV recurrence may require the identification of “too-sick-to-treat patients” to avoid futile treatments.

Original languageEnglish
Pages (from-to)858-864
Number of pages7
JournalJournal of Viral Hepatitis
Volume24
Issue number10
DOIs
Publication statusPublished - Oct 1 2017

Fingerprint

Hepacivirus
Hepatitis
Antiviral Agents
Transplants
Recurrence
Interferons
Compassionate Use Trials
Medical Futility
Mortality
Ribavirin
Hepatitis C
Survivors
Fibrosis
Cohort Studies
Therapeutics
Survival
Liver
Sofosbuvir

Keywords

  • antiviral therapy
  • fibrosing cholestatic hepatitis
  • liver transplant
  • long-term outcome
  • severe hepatitis C virus recurrence

ASJC Scopus subject areas

  • Hepatology
  • Infectious Diseases
  • Virology

Cite this

Long-term outcomes of direct acting antivirals in post-transplant advanced hepatitis C virus recurrence and fibrosing cholestatic hepatitis. / Vukotic, R.; Conti, F.; Fagiuoli, S.; Morelli, M. C.; Pasulo, L.; Colpani, M.; Foschi, F. G.; Berardi, S.; Pianta, P.; Mangano, M.; Donato, M. F.; Malinverno, F.; Monico, S.; Tamè, M.; Mazzella, G.; Belli, L. S.; Viganò, R.; Carrai, P.; Burra, P.; Russo, F. P.; Lenci, I.; Toniutto, P.; Merli, M.; Loiacono, L.; Iemmolo, R.; Degli Antoni, A. M.; Romano, A.; Picciotto, A.; Rendina, M.; Andreone, P.; AISF-SOFOLT Study group.

In: Journal of Viral Hepatitis, Vol. 24, No. 10, 01.10.2017, p. 858-864.

Research output: Contribution to journalArticle

Vukotic, R, Conti, F, Fagiuoli, S, Morelli, MC, Pasulo, L, Colpani, M, Foschi, FG, Berardi, S, Pianta, P, Mangano, M, Donato, MF, Malinverno, F, Monico, S, Tamè, M, Mazzella, G, Belli, LS, Viganò, R, Carrai, P, Burra, P, Russo, FP, Lenci, I, Toniutto, P, Merli, M, Loiacono, L, Iemmolo, R, Degli Antoni, AM, Romano, A, Picciotto, A, Rendina, M, Andreone, P & AISF-SOFOLT Study group 2017, 'Long-term outcomes of direct acting antivirals in post-transplant advanced hepatitis C virus recurrence and fibrosing cholestatic hepatitis', Journal of Viral Hepatitis, vol. 24, no. 10, pp. 858-864. https://doi.org/10.1111/jvh.12712
Vukotic, R. ; Conti, F. ; Fagiuoli, S. ; Morelli, M. C. ; Pasulo, L. ; Colpani, M. ; Foschi, F. G. ; Berardi, S. ; Pianta, P. ; Mangano, M. ; Donato, M. F. ; Malinverno, F. ; Monico, S. ; Tamè, M. ; Mazzella, G. ; Belli, L. S. ; Viganò, R. ; Carrai, P. ; Burra, P. ; Russo, F. P. ; Lenci, I. ; Toniutto, P. ; Merli, M. ; Loiacono, L. ; Iemmolo, R. ; Degli Antoni, A. M. ; Romano, A. ; Picciotto, A. ; Rendina, M. ; Andreone, P. ; AISF-SOFOLT Study group. / Long-term outcomes of direct acting antivirals in post-transplant advanced hepatitis C virus recurrence and fibrosing cholestatic hepatitis. In: Journal of Viral Hepatitis. 2017 ; Vol. 24, No. 10. pp. 858-864.
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T1 - Long-term outcomes of direct acting antivirals in post-transplant advanced hepatitis C virus recurrence and fibrosing cholestatic hepatitis

AU - Vukotic, R.

AU - Conti, F.

AU - Fagiuoli, S.

AU - Morelli, M. C.

AU - Pasulo, L.

AU - Colpani, M.

AU - Foschi, F. G.

AU - Berardi, S.

AU - Pianta, P.

AU - Mangano, M.

AU - Donato, M. F.

AU - Malinverno, F.

AU - Monico, S.

AU - Tamè, M.

AU - Mazzella, G.

AU - Belli, L. S.

AU - Viganò, R.

AU - Carrai, P.

AU - Burra, P.

AU - Russo, F. P.

AU - Lenci, I.

AU - Toniutto, P.

AU - Merli, M.

AU - Loiacono, L.

AU - Iemmolo, R.

AU - Degli Antoni, A. M.

AU - Romano, A.

AU - Picciotto, A.

AU - Rendina, M.

AU - Andreone, P.

AU - AISF-SOFOLT Study group

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N2 - Long-term functional outcomes of sofosbuvir-based antiviral treatment were evaluated in a cohort study involving 16 Italian centres within the international compassionate use programme for post-transplant hepatitis C virus (HCV) recurrence. Seventy-three patients with cirrhosis (n=52) or fibrosing cholestatic hepatitis (FCH, n=21) received 24-week sofosbuvir with ribavirin±pegylated interferon or interferon-free sofosbuvir-based regimen with daclatasvir/simeprevir+ribavirin. The patients were observed for a median time of 103 (82-112) weeks. Twelve of 73 (16.4%) died (10 non-FCH, 2 FCH) and two underwent re-LT. Sustained virological response was achieved in 46 of 66 (69.7%): 31 of 47 (66%) non-FCH and 15 of 19 (79%) FCH patients. All relapsers were successfully retreated. Comparing the data of baseline with last follow-up, MELD and Child-Turcotte-Pugh scores improved both in non-FCH (15.3±6.5 vs 10.5±3.8, P<.0001 and 8.4±2.1 vs 5.7±1.3, P<.0001, respectively) and FCH (17.3±5.9 vs 10.1±2.8, P=.001 and 8.2±1.6 vs 5.5±1, P=.001, respectively). Short-treatment mortality was higher in patients with baseline MELD≥25 than in those with MELD<25 (42.9% vs 4.8%, P=.011). Long-term mortality was 53.3% among patients with baseline MELD≥20 and 7.5% among those with MELD<20 (P<.0001). Among deceased patients 75% were Child-Turcotte-Pugh class C at baseline, while among survivors 83.9% were class A or B (P<.0001). Direct acting antivirals-based treatments for severe post-transplant hepatitis C recurrence, comprising fibrosing cholestatic hepatitis, significantly improve liver function, even without viral clearance and permit an excellent long-term survival. The setting of severe HCV recurrence may require the identification of “too-sick-to-treat patients” to avoid futile treatments.

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