Abstract

Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.

Original languageEnglish
Pages (from-to)607-615
Number of pages9
JournalInfection
Volume46
Issue number5
DOIs
Publication statusPublished - 2018

Fingerprint

Ritonavir
Ribavirin
Hepacivirus
Fibrosis
Genotype
Safety
Multivariate Analysis
Compassionate Use Trials
Bilirubin
Albumins
Pharmacokinetics
ABT-450
ABT-267
ABT-333
RNA
Hypertension
Therapeutics
Infection

Keywords

  • Cirrhosis
  • Dasabuvir
  • Elderly
  • Ombitasvir
  • Paritaprevir

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis. / For The Abacus Study Group.

In: Infection, Vol. 46, No. 5, 2018, p. 607-615.

Research output: Contribution to journalArticle

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title = "Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis",
abstract = "Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8{\%}); 13/240 (5.4{\%}) discontinued the treatment. A multivariate analysis found albumin < 3.5 g/dL (OR 2.04: 95{\%} CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95{\%} CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95{\%} (228/240). Multivariate analysis identified baseline bilirubin < 2 mg/dL (OR 4.9: 95{\%} CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.",
keywords = "Cirrhosis, Dasabuvir, Elderly, Ombitasvir, Paritaprevir",
author = "{For The Abacus Study Group} and Antonio Ascione and {de Luca}, Massimo and Mario Melazzini and Simona Montilla and Trotta, {Maria Paola} and Salvatore Petta and Massimo Puoti and Vincenzo Sangiovanni and Vincenzo Messina and Savino Bruno and Antonio Izzi and Erica Villa and Alessio Aghemo and Zignego, {Anna Linda} and Alessandra Orlandini and Luca Fontanella and Antonio Gasbarrini and Marco Marzioni and Giannini, {Edoardo G.} and Antonio Crax{\`i} and Giuseppe Abbati and Alfredo Alberti and Pietro Andreone and Massimo Andreoni and Andrea Antinori and Michele Barone and Raffaele Bruno and Giuseppina Brancaccio and Serena Cima and Massimo Colombo and Raffaele Cozzolongo and Antonio Cristaudo and {de Luca}, Andrea and {Di Stefano}, Marco and Carlo Ferrari and Roberto Gulminetti and Adriano Lazzarin and Raffaella Lionetti and Renato Maserati and Michele Milella and Mario Mondelli and Marzia Montalbano and Giovanna Onnelli and Perno, {Carlo Federico} and Maria Rendina and Mario Rizzetto and Cristina Rossi and Rumi, {Maria Grazia} and Russo, {Francesca Paolo} and Maria Vinci",
year = "2018",
doi = "10.1007/s15010-018-1157-x",
language = "English",
volume = "46",
pages = "607--615",
journal = "Infection",
issn = "0300-8126",
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TY - JOUR

T1 - Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

AU - For The Abacus Study Group

AU - Ascione, Antonio

AU - de Luca, Massimo

AU - Melazzini, Mario

AU - Montilla, Simona

AU - Trotta, Maria Paola

AU - Petta, Salvatore

AU - Puoti, Massimo

AU - Sangiovanni, Vincenzo

AU - Messina, Vincenzo

AU - Bruno, Savino

AU - Izzi, Antonio

AU - Villa, Erica

AU - Aghemo, Alessio

AU - Zignego, Anna Linda

AU - Orlandini, Alessandra

AU - Fontanella, Luca

AU - Gasbarrini, Antonio

AU - Marzioni, Marco

AU - Giannini, Edoardo G.

AU - Craxì, Antonio

AU - Abbati, Giuseppe

AU - Alberti, Alfredo

AU - Andreone, Pietro

AU - Andreoni, Massimo

AU - Antinori, Andrea

AU - Barone, Michele

AU - Bruno, Raffaele

AU - Brancaccio, Giuseppina

AU - Cima, Serena

AU - Colombo, Massimo

AU - Cozzolongo, Raffaele

AU - Cristaudo, Antonio

AU - de Luca, Andrea

AU - Di Stefano, Marco

AU - Ferrari, Carlo

AU - Gulminetti, Roberto

AU - Lazzarin, Adriano

AU - Lionetti, Raffaella

AU - Maserati, Renato

AU - Milella, Michele

AU - Mondelli, Mario

AU - Montalbano, Marzia

AU - Onnelli, Giovanna

AU - Perno, Carlo Federico

AU - Rendina, Maria

AU - Rizzetto, Mario

AU - Rossi, Cristina

AU - Rumi, Maria Grazia

AU - Russo, Francesca Paolo

AU - Vinci, Maria

PY - 2018

Y1 - 2018

N2 - Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.

AB - Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.

KW - Cirrhosis

KW - Dasabuvir

KW - Elderly

KW - Ombitasvir

KW - Paritaprevir

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U2 - 10.1007/s15010-018-1157-x

DO - 10.1007/s15010-018-1157-x

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