Direct Acting Antivirals (DAAs)
This guide has been developed as part of a Risk Management Plan (RMP) for prescribers involved in the care of patients treated with DAAs, to provide further information about some new safety issues associated with their use.
This guide is complementary to the full prescribing information of each product, please refer to it for further information and additional details.
DAAs are several oral regimens from different families [NS5B nucleotide inhibitors, NS5B non-nucleoside inhibitors, NS5A replication complex inhibitors and NS3/4A protease inhibitors (PI)] indicated for the treatment of chronic hepatitis C.
These regimens result in an increase in sustained virological response (SVR) rates to above 90% and reduce the duration of treatment to 12 weeks or less.
Since drug-resistant variants have rapidly developed in response to monotherapy with almost all DAAs for HCV, the need for combination therapies to effectively eradicate the virus from infected patients is clear.
EPVC is supporting the additional monitoring program which assign a list of products to be monitored even more intensively than other medicines, the labelling information of these products contain the symbol of inverted black triangle ().
Reporting Suspected Adverse Reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in the product information.
EPVC encourages HealthCare Professionals (HCPs) to report any suspected adverse reaction with any suspected drug however EPVC has special interest to receive reports on some products including Direct Acting Antivirals (DAAs).
To download the prescriber guide click here