Department of Medicine, Centre for Liver Disease, Buon Consiglio-Fatebenefratelli Hospital, Via Manzoni 220, 80123, Naples, Italy. firstname.lastname@example.org.
Liver Unit, AORN Cardarelli, Naples, Italy.
Italian Medicines Agency (AIFA), Rome, Italy.
Department of Gastroenterology, DiBiMIS, University of Palermo, Palermo, Italy.
Division of Infectious Diseases, AO Niguarda Ca' Granda Hospital, Milan, Italy.
III U.O.C. P.O. Cotugno, AORN Ospedali dei Colli, Naples, Italy.
Infectious Diseases Unit, AORN Caserta, Caserta, Italy.
Humanitas University and IRCCS Clinical Institute Humanitas, Rozzano, Milan, Italy.
Infectious Disease, Cotugno Hospital, AORN Ospedali dei Colli, Naples, Italy.
Gastroenterology Unit, Department of Internal Medicine, AOU Policlinico of Modena, Modena, Italy.
UO Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Hospital Maggiore Policlinico of Milan, Milan, Italy.
Interdepartmental Centre for Systemic Manifestations of Hepatitis Viruses (MaSVE), Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Unit of Infectious Diseases and Hepatology, AOU of Parma, Parma, Italy.
Department of Medicine, Centre for Liver Disease, Buon Consiglio-Fatebenefratelli Hospital, Via Manzoni 220, 80123, Naples, Italy.
Internal Medicine, Gastroenterology and Hepatology, Agostino Gemelli Hospital, Rome, Italy.
Clinic of Gastroenterology and Hepatology, Università Politecnica delle Marche, Ancona, Italy.
Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy.
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.
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).
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.
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.