New era in treatment options of chronic hepatitis C: focus on safety of new direct-acting antivirals (DAAs)

ABSTRACT

Introduction: 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

Article highlights

• The therapeutic management of HCV infection radically changed thanks to the introduction of new DAAs

• Preliminary data have shown that these drugs have a higher efficacy and fewer adverse events compared to ribavirin and peginterferon combined therapy

• Despite these encouraging data, the safety profile of new DAAs is still not completely known

• Pharmacovigilance activities represents the main instrument in order to improve patient care and safety in relation to the use of DAAs

This box summarizes key points contained in the article.

Declaration of interest

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This paper is part of a supplemental issue funded by the Second University of Naples.