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 language | English |
|---|---|
| Pages (from-to) | 607-615 |
| Number of pages | 9 |
| Journal | Infection |
| Volume | 46 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 2018 |
Fingerprint
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 journal › Article
}
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
UR - http://www.scopus.com/inward/record.url?scp=85047665007&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85047665007&partnerID=8YFLogxK
U2 - 10.1007/s15010-018-1157-x
DO - 10.1007/s15010-018-1157-x
M3 - Article
AN - SCOPUS:85047665007
VL - 46
SP - 607
EP - 615
JO - Infection
JF - Infection
SN - 0300-8126
IS - 5
ER -