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

Roberto Rossotti, Alessandro Tavelli, Stefano Bonora, Antonella Cingolani, Sergio Lo Caputo, Annalisa Saracino, Alessandro Soria, Letizia Marinaro, Caterina Uberti-Foppa, Cristina Mussini, Massimo Puoti, Antonella d'Arminio Monforte

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)447-451
Number of pages5
JournalDigestive and Liver Disease
Volume52
Issue number4
DOIs
Publication statusPublished - Apr 2020

Keywords

  • Adequate prescription
  • DAA
  • Daclatasvir
  • Drug–drug interactions
  • HCV
  • HIV co-infection

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Fingerprint Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this