Furthermore, the applicant has requested that the use of daclatsvir with pegIFN/RBV, as used in the AI444042 study, be cited as a recommended regimen in section 4.2. of the
SmPC. While the, relatively speaking, inferior safety profile of interferon-based regimens is recognised, the efficacy data from this study, along with the totality of the safety database for daclatasvir when used with pegIFN/RBV, is supportive of this proposal.