TY - JOUR
T1 - Safety and efficacy of daclatasvir at doses other than 60 mg daily in HIV/HCV co-infected subjects
T2 - Data from the ICONA/HepaICONA foundation cohorts
AU - Rossotti, Roberto
AU - Tavelli, Alessandro
AU - Bonora, Stefano
AU - Cingolani, Antonella
AU - Lo Caputo, Sergio
AU - Saracino, Annalisa
AU - Soria, Alessandro
AU - Marinaro, Letizia
AU - Uberti-Foppa, Caterina
AU - Mussini, Cristina
AU - Puoti, Massimo
AU - d'Arminio Monforte, Antonella
N1 - Funding Information:
ICONA Foundation is supported by unrestricted grants from Gilead Sciences , Janssen, MSD and ViiV Healthcare . No specific funding support was planned for study design, data collection and analysis and manuscript writing of this paper.
Publisher Copyright:
© 2019 Editrice Gastroenterologica Italiana S.r.l.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/4
Y1 - 2020/4
N2 - 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.
AB - 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.
KW - Adequate prescription
KW - DAA
KW - Daclatasvir
KW - Drug–drug interactions
KW - HCV
KW - HIV co-infection
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U2 - 10.1016/j.dld.2019.12.007
DO - 10.1016/j.dld.2019.12.007
M3 - Article
C2 - 31959479
AN - SCOPUS:85077997598
VL - 52
SP - 447
EP - 451
JO - Digestive and Liver Disease
JF - Digestive and Liver Disease
SN - 1590-8658
IS - 4
ER -