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

A. Ascione, M. De Luca, M. Melazzini, S. Montilla, M.P. Trotta, S. Petta, M. Puoti, V. Sangiovanni, V. Messina, S. Bruno, A. Izzi, E. Villa, A. Aghemo, A.L. Zignego, A. Orlandini, L. Fontanella, A. Gasbarrini, M. Marzioni, E.G. Giannini, A. CraxìG. Abbati, A. Alberti, P. Andreone, M. Andreoni, P. Angeli, M. Angelico, G. Angarano, D. Angrisani, A. Antinori, C. Antonini, I. Avancini, M. Barone, R. Bruno, A. Benedetti, V. Bernabucci, P. Blanc, C. Boarini, N. Boffa, L. Boglione, V. Borghi, G. Borgia, G. Brancaccio, M. Brunetto, I. Cacciola, P. Calabrese, V. Calvaruso, D. Campagnolo, A. Grieco, L. Miele, G.L. Rapaccini

Research output: Contribution to journalArticle

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. © 2018, Springer-Verlag GmbH Germany, part of Springer Nature.
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
Germany
Albumins
Pharmacokinetics
ABT-450
ABT-267
ABT-333
RNA
Hypertension
Therapeutics
Infection

Keywords

  • albumin
  • dasabuvir plus ombitasvir plus paritaprevir plus ritonavir
  • virus RNA
  • ABT-267
  • ABT-333
  • ABT-450
  • anilide
  • antivirus agent
  • biological marker
  • carbamic acid derivative
  • macrocyclic compound
  • ribavirin
  • ritonavir
  • sulfonamide
  • uracil, aged
  • anemia
  • antiviral therapy
  • anxiety
  • appetite disorder
  • Article
  • ascites
  • asthenia
  • atrial fibrillation
  • brain disease
  • controlled study
  • coughing
  • dermatitis
  • diarrhea
  • dizziness
  • drug efficacy
  • drug safety
  • drug withdrawal
  • dyspnea
  • epigastric pain
  • epistaxis
  • estimated glomerular filtration rate
  • female
  • glossitis
  • glucose blood level
  • heart palpitation
  • hepatitis
  • hepatitis C
  • herpes zoster
  • human
  • hyperbilirubinemia
  • hypertension
  • hypokalemia
  • hypotension
  • insomnia
  • lichen planus
  • liver cell carcinoma
  • liver cirrhosis
  • longitudinal study
  • lymphoma
  • major clinical study
  • male
  • myasthenia
  • nausea
  • observational study
  • pneumonia
  • prospective study
  • pruritus
  • rash
  • side effect
  • sweat gland disease
  • tachycardia
  • thorax pain
  • tooth abscess
  • transient ischemic attack
  • urinary tract infection
  • analogs and derivatives
  • chronic hepatitis C
  • combination drug therapy
  • complication
  • genetics
  • genotype
  • Hepacivirus
  • treatment outcome
  • very elderly
  • virology, Aged
  • Aged, 80 and over
  • Anilides
  • Antiviral Agents
  • Biomarkers
  • Carbamates
  • Drug Therapy, Combination
  • Female
  • Genotype
  • Hepatitis C, Chronic
  • Humans
  • Liver Cirrhosis
  • Macrocyclic Compounds
  • Male
  • Ribavirin
  • Ritonavir
  • Sulfonamides
  • Treatment Outcome
  • Uracil

Cite this

Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis. / Ascione, A.; De Luca, M.; Melazzini, M.; Montilla, S.; Trotta, M.P.; Petta, S.; Puoti, M.; Sangiovanni, V.; Messina, V.; Bruno, S.; Izzi, A.; Villa, E.; Aghemo, A.; Zignego, A.L.; Orlandini, A.; Fontanella, L.; Gasbarrini, A.; Marzioni, M.; Giannini, E.G.; Craxì, A.; Abbati, G.; Alberti, A.; Andreone, P.; Andreoni, M.; Angeli, P.; Angelico, M.; Angarano, G.; Angrisani, D.; Antinori, A.; Antonini, C.; Avancini, I.; Barone, M.; Bruno, R.; Benedetti, A.; Bernabucci, V.; Blanc, P.; Boarini, C.; Boffa, N.; Boglione, L.; Borghi, V.; Borgia, G.; Brancaccio, G.; Brunetto, M.; Cacciola, I.; Calabrese, P.; Calvaruso, V.; Campagnolo, D.; Grieco, A.; Miele, L.; Rapaccini, G.L.

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

Research output: Contribution to journalArticle

Ascione, A, De Luca, M, Melazzini, M, Montilla, S, Trotta, MP, Petta, S, Puoti, M, Sangiovanni, V, Messina, V, Bruno, S, Izzi, A, Villa, E, Aghemo, A, Zignego, AL, Orlandini, A, Fontanella, L, Gasbarrini, A, Marzioni, M, Giannini, EG, Craxì, A, Abbati, G, Alberti, A, Andreone, P, Andreoni, M, Angeli, P, Angelico, M, Angarano, G, Angrisani, D, Antinori, A, Antonini, C, Avancini, I, Barone, M, Bruno, R, Benedetti, A, Bernabucci, V, Blanc, P, Boarini, C, Boffa, N, Boglione, L, Borghi, V, Borgia, G, Brancaccio, G, Brunetto, M, Cacciola, I, Calabrese, P, Calvaruso, V, Campagnolo, D, Grieco, A, Miele, L & Rapaccini, GL 2018, 'Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis', Infection, vol. 46, no. 5, pp. 607-615. https://doi.org/10.1007/s15010-018-1157-x
Ascione, A. ; De Luca, M. ; Melazzini, M. ; Montilla, S. ; Trotta, M.P. ; Petta, S. ; Puoti, M. ; Sangiovanni, V. ; Messina, V. ; Bruno, S. ; Izzi, A. ; Villa, E. ; Aghemo, A. ; Zignego, A.L. ; Orlandini, A. ; Fontanella, L. ; Gasbarrini, A. ; Marzioni, M. ; Giannini, E.G. ; Craxì, A. ; Abbati, G. ; Alberti, A. ; Andreone, P. ; Andreoni, M. ; Angeli, P. ; Angelico, M. ; Angarano, G. ; Angrisani, D. ; Antinori, A. ; Antonini, C. ; Avancini, I. ; Barone, M. ; Bruno, R. ; Benedetti, A. ; Bernabucci, V. ; Blanc, P. ; Boarini, C. ; Boffa, N. ; Boglione, L. ; Borghi, V. ; Borgia, G. ; Brancaccio, G. ; Brunetto, M. ; Cacciola, I. ; Calabrese, P. ; Calvaruso, V. ; Campagnolo, D. ; Grieco, A. ; Miele, L. ; Rapaccini, G.L. / Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis. In: Infection. 2018 ; Vol. 46, No. 5. pp. 607-615.
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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. {\circledC} 2018, Springer-Verlag GmbH Germany, part of Springer Nature.",
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T1 - Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

AU - Ascione, A.

AU - De Luca, M.

AU - Melazzini, M.

AU - Montilla, S.

AU - Trotta, M.P.

AU - Petta, S.

AU - Puoti, M.

AU - Sangiovanni, V.

AU - Messina, V.

AU - Bruno, S.

AU - Izzi, A.

AU - Villa, E.

AU - Aghemo, A.

AU - Zignego, A.L.

AU - Orlandini, A.

AU - Fontanella, L.

AU - Gasbarrini, A.

AU - Marzioni, M.

AU - Giannini, E.G.

AU - Craxì, A.

AU - Abbati, G.

AU - Alberti, A.

AU - Andreone, P.

AU - Andreoni, M.

AU - Angeli, P.

AU - Angelico, M.

AU - Angarano, G.

AU - Angrisani, D.

AU - Antinori, A.

AU - Antonini, C.

AU - Avancini, I.

AU - Barone, M.

AU - Bruno, R.

AU - Benedetti, A.

AU - Bernabucci, V.

AU - Blanc, P.

AU - Boarini, C.

AU - Boffa, N.

AU - Boglione, L.

AU - Borghi, V.

AU - Borgia, G.

AU - Brancaccio, G.

AU - Brunetto, M.

AU - Cacciola, I.

AU - Calabrese, P.

AU - Calvaruso, V.

AU - Campagnolo, D.

AU - Grieco, A.

AU - Miele, L.

AU - Rapaccini, G.L.

N1 - cited By 0

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. © 2018, Springer-Verlag GmbH Germany, part of Springer Nature.

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. © 2018, Springer-Verlag GmbH Germany, part of Springer Nature.

KW - albumin

KW - dasabuvir plus ombitasvir plus paritaprevir plus ritonavir

KW - virus RNA

KW - ABT-267

KW - ABT-333

KW - ABT-450

KW - anilide

KW - antivirus agent

KW - biological marker

KW - carbamic acid derivative

KW - macrocyclic compound

KW - ribavirin

KW - ritonavir

KW - sulfonamide

KW - uracil, aged

KW - anemia

KW - antiviral therapy

KW - anxiety

KW - appetite disorder

KW - Article

KW - ascites

KW - asthenia

KW - atrial fibrillation

KW - brain disease

KW - controlled study

KW - coughing

KW - dermatitis

KW - diarrhea

KW - dizziness

KW - drug efficacy

KW - drug safety

KW - drug withdrawal

KW - dyspnea

KW - epigastric pain

KW - epistaxis

KW - estimated glomerular filtration rate

KW - female

KW - glossitis

KW - glucose blood level

KW - heart palpitation

KW - hepatitis

KW - hepatitis C

KW - herpes zoster

KW - human

KW - hyperbilirubinemia

KW - hypertension

KW - hypokalemia

KW - hypotension

KW - insomnia

KW - lichen planus

KW - liver cell carcinoma

KW - liver cirrhosis

KW - longitudinal study

KW - lymphoma

KW - major clinical study

KW - male

KW - myasthenia

KW - nausea

KW - observational study

KW - pneumonia

KW - prospective study

KW - pruritus

KW - rash

KW - side effect

KW - sweat gland disease

KW - tachycardia

KW - thorax pain

KW - tooth abscess

KW - transient ischemic attack

KW - urinary tract infection

KW - analogs and derivatives

KW - chronic hepatitis C

KW - combination drug therapy

KW - complication

KW - genetics

KW - genotype

KW - Hepacivirus

KW - treatment outcome

KW - very elderly

KW - virology, Aged

KW - Aged, 80 and over

KW - Anilides

KW - Antiviral Agents

KW - Biomarkers

KW - Carbamates

KW - Drug Therapy, Combination

KW - Female

KW - Genotype

KW - Hepatitis C, Chronic

KW - Humans

KW - Liver Cirrhosis

KW - Macrocyclic Compounds

KW - Male

KW - Ribavirin

KW - Ritonavir

KW - Sulfonamides

KW - Treatment Outcome

KW - Uracil

U2 - 10.1007/s15010-018-1157-x

DO - 10.1007/s15010-018-1157-x

M3 - Article

VL - 46

SP - 607

EP - 615

JO - Infection

JF - Infection

SN - 0300-8126

IS - 5

ER -