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

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. Describe the use of different DCV dosages; assess if dose prescription complies with Summaries of Product Characteristics (SmPC);...

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Bibliographic Details
Published in:Digestive and liver disease 2020-04, Vol.52 (4), p.447-451
Main 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
Format: Article
Language:English
Subjects:
Adequate prescription
Antiviral Agents - therapeutic use
Carbamates - administration & dosage
Carbamates - therapeutic use
Coinfection
DAA
Daclatasvir
Drug Therapy, Combination
Drug–drug interactions
Female
HCV
Hepatitis C, Chronic - drug therapy
HIV co-infection
HIV Infections - drug therapy
Humans
Imidazoles - administration & dosage
Imidazoles - therapeutic use
Italy
Male
Middle Aged
Pyrrolidines - administration & dosage
Pyrrolidines - therapeutic use
Regression Analysis
Retrospective Studies
Ribavirin - therapeutic use
Simeprevir - therapeutic use
Sofosbuvir - therapeutic use
Sustained Virologic Response
Valine - administration & dosage
Valine - analogs & derivatives
Valine - therapeutic use
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Summary: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. 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. 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. 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 
ISSN:1590-8658
1878-3562
DOI:10.1016/j.dld.2019.12.007