title: New era in treatment options of chronic hepatitis C: focus on safety of new direct-acting antivirals (DAAs).
abstract: New direct-acting antivirals have changed hepatitis C virus infection management extremely. Areas covered: The pharmacological management of HCV infection and the main characteristics of new DAA therapies have been discussed. In order to analyse safety data regarding DAA therapies, a narrative review was performed searching for safety results of main second generation DAAs pivotal and post-marketing studies. Data on main DAAs drug-drug interactions have also been discussed. Results of main DAAs pivotal studies revealed that these drugs were frequently associated to adverse events such as asthenia, headache, nausea, and insomnia. Although some of post-marketing studies confirmed the good tolerability profile already detected in the pre-marketing phase, real-world safety data showed that second generation DAAs can be associated to cutaneous, metabolic, pulmonary, hepatic, and renal adverse events. Expert opinion: Safety results of pivotal and post-marketing studies indicated that the most recently approved DAAs are well tolerated. However, considering the recent marketing approval of new DAAs, further observational studies and post-marketing surveillance activities will be necessary in order to improve the knowledge of their safety.
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology , Second University of Naples , Naples , Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Scavone
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology , Second University of Naples , Naples , Italy.
authors.forename: Liberata
authors.initials: L
authors.lastname: Sportiello
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology , Second University of Naples , Naples , Italy.
authors.forename: Concetta
authors.initials: C
authors.lastname: Rafaniello
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology , Second University of Naples , Naples , Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Mascolo
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology , Second University of Naples , Naples , Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Sessa
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology , Second University of Naples , Naples , Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Rossi
authors.affiliation: a Department of Experimental Medicine, Section of Pharmacology , Second University of Naples , Naples , Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Capuano
mesh_terms: D000818:Animals; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D004347:Drug Interactions; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans
chemical_list: D000998:Antiviral Agents
keywords: Direct acting antiviral; HCV; pre-marketing studies; real-world data; safety