Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects: Data from the ICONA/HepaICONA foundation cohorts

tBackground: Daclatasvir (DCV) is a HCV NS5A inhibitor whose plasma exposure may be influenced byco-administration with inducers or inhibitors of CYP3A4 such as many antiretrovirals.Aims: Describe the use of different DCV dosages; assess if dose prescription complies with Summariesof Product Characteristics (SmPC); evaluate safety and efficacy of 60 versus 30/90 mg and adequate (i.e.concordant with SmPC) versus incorrect prescriptions.Methods: Retrospective analysis of patients included in ICONA/HepaICONA starting a DCV-including treat-ment. Incidence rates of liver adverse events (LAE) were calculated; Poisson regression model was usedto identify factors associated with LAE.Results: 311 patients were included: 250 (80.4%) received DCV at a dosage of 60 mg, 52 (16.7%) 30 mg and 9(2.9%) 90 mg. An inadequate dosage was used in 18 individuals (5.8%). No difference in SVR was observed(93.8% with 60 mg and 94.2% with 30/90 mg, p = 0.910; 93.5% with adequate and 100% with incorrectdosage, p = 0.277). There were 36 LAE with no differences in the two-paired groups. Decompensated liverdisease was a risk factor for LAE (aRR = 2.37; p = 0.034), while HIV RNA < 50 copies/ml resulted protective(aRR = 0.22; p = 0.003).Conclusions: DCV use resulted in high SVR rate regardless of dosage and correctness of prescription.