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.
Keywords: Direct acting antiviral; HCV; pre-marketing studies; real-world data; safety.