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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. Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis. Infection 2018; 46:607-615. [PMID: 29808463 DOI: 10.1007/s15010-018-1157-x] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/23/2018] [Accepted: 05/22/2018] [Indexed: 02/07/2023]
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.
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Affiliation(s)
- Antonio Ascione
- Department of Medicine, Centre for Liver Disease, Buon Consiglio-Fatebenefratelli Hospital, Via Manzoni 220, 80123, Naples, Italy.
| | | | | | | | | | - Salvatore Petta
- Department of Gastroenterology, DiBiMIS, University of Palermo, Palermo, Italy
| | - Massimo Puoti
- Division of Infectious Diseases, AO Niguarda Ca' Granda Hospital, Milan, Italy
| | | | | | - Savino Bruno
- Humanitas University and IRCCS Clinical Institute Humanitas, Rozzano, Milan, Italy
| | - Antonio Izzi
- Infectious Disease, Cotugno Hospital, AORN Ospedali dei Colli, Naples, Italy
| | - Erica Villa
- Gastroenterology Unit, Department of Internal Medicine, AOU Policlinico of Modena, Modena, Italy
| | - Alessio Aghemo
- UO Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Hospital Maggiore Policlinico of Milan, Milan, Italy
| | - Anna Linda Zignego
- Interdepartmental Centre for Systemic Manifestations of Hepatitis Viruses (MaSVE), Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy
| | | | - Luca Fontanella
- Department of Medicine, Centre for Liver Disease, Buon Consiglio-Fatebenefratelli Hospital, Via Manzoni 220, 80123, Naples, Italy
| | - Antonio Gasbarrini
- Internal Medicine, Gastroenterology and Hepatology, Agostino Gemelli Hospital, Rome, Italy
| | - Marco Marzioni
- Clinic of Gastroenterology and Hepatology, Università Politecnica delle Marche, Ancona, Italy
| | - Edoardo G Giannini
- Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy
| | - Antonio Craxì
- Department of Gastroenterology, DiBiMIS, University of Palermo, Palermo, Italy
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Saracco GM, Evangelista A, Fagoonee S, Ciccone G, Bugianesi E, Caviglia GP, Abate ML, Rizzetto M, Pellicano R, Smedile A. Etiology of chronic liver diseases in the Northwest of Italy, 1998 through 2014. World J Gastroenterol 2016; 22:8187-8193. [PMID: 27688660 PMCID: PMC5037087 DOI: 10.3748/wjg.v22.i36.8187] [Citation(s) in RCA: 41] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/22/2016] [Revised: 08/08/2016] [Accepted: 08/30/2016] [Indexed: 02/06/2023] Open
Abstract
AIM To assess the etiology of chronic liver diseases (CLD) from 1998 to 2014 at the outpatient clinic of Gastroenterology of the main hospital in Northwest of Italy among those dedicated to hepatology.
METHODS A random sample of charts of patients referred to for increased liver enzymes between January 1998 and December 2006, and between January 2012 and December 2014 were reviewed. Etiology search included testing for hepatitis B virus (HBV), hepatitis C virus (HCV), autoimmune hepatitis, primary biliary cirrhosis, Wilson’s disease and hereditary hemocromatosis. A risky alcohol consumption was also considered. Non-alcoholic fatty liver disease (NAFLD) was diagnosed in patients with histological and/or ultrasound evidence of steatosis/steatohepatitis, and without other causes of CLD.
RESULTS The number of patients included was 1163. Of them, 528 (45%) had positivity for HCV and 85 (7%) for HBV. Among the virus-free patients, 417 (36%) had metabolic disorders whereas the remaining had history of alcohol abuse, less prevalent causes of CLD or concomitant conditions. In comparison to 1998-2000 (41%), a reduction of HCV alone-related cases was detected during the periods 2001-2003 (35%, OR = 0.75, 95%CI: 0.53-1.06), 2004-2006 (33%, OR = 0.70, 95%CI: 0.50-0.97) and 2012-2014 (31%, OR = 0.64, 95%CI: 0.46-0.91). On the contrary, in comparison to 1998-2000 (31%), metabolic-alone disorders increased in the period 2004-2006 (39%, OR = 1.37, 95%CI: 0.99-1.91) and 2012-2014 (41%, OR = 1.53, 95%CI: 1.09-2.16). The other etiologies remained stable. The increase of incidence of metabolic-alone etiology during the period 2004-2006 and 2012-2014 tended to be higher in older patients (≥ 50 years) compared to younger (P = 0.058).
CONCLUSION In the Northwest of Italy, during this study period, the prevalence of HCV infection decreased notably whereas that of NAFLD increased.
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