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. Issue 4 (April 2020)

• Record Type: Journal Article
• Authors: Rossotti, Roberto; Tavelli, Alessandro; Bonora, Stefano; Cingolani, Antonella; Lo Caputo, Sergio; Saracino, Annalisa; Soria, Alessandro; Marinaro, Letizia; Uberti-Foppa, Caterina; Mussini, Cristina; Puoti, Massimo; d'Arminio Monforte, Antonella
• Is Part Of: Digestive and liver disease. Volume 52:Issue 4(2020)
• Page Start: 447
• Page End: 451
• Publication Date: 2020-04
• Subjects: Adequate prescription -- Daclatasvir -- Drug–drug interactions -- DAA -- HCV -- HIV co-infection; Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; 616.33005
• DOI: 10.1016/j.dld.2019.12.007
• Languages: English
• ISSNs: 1590-8658

Abstract

Abstract: Background: Daclatasvir (DCV) is a HCV NS5A inhibitor whose plasma exposure may be influenced by co-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 Summaries of 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 treatment. Incidence rates of liver adverse events (LAE) were calculated; Poisson regression model was used to 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 incorrect dosage, p = 0.277). There were 36 LAE with no differences in the two-paired groups. Decompensated liver disease 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.