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
| Autor: | Rossotti, R., Tavelli, A., Bonora, S., Cingolani, A., Lo Caputo, S., Saracino, A., Soria, A., Marinaro, L., Uberti-Foppa, C., Mussini, C., Puoti, M., on behalf of the Icona Foundation Study Group, D’Arminio Monforte A., Nunnari, G., G. F. Pellicanò. |
|---|---|
| Přispěvatelé: | Rossotti, R., Tavelli, A., Bonora, S., Cingolani, A., Lo Caputo, S., Saracino, A., Soria, A., Marinaro, L., Uberti-Foppa, C., Mussini, C., Puoti, M., d'Arminio Monforte, A., Rossotti, R, Tavelli, A, Bonora, S, Cingolani, A, Lo Caputo, S, Saracino, A, Soria, A, Marinaro, L, Uberti-Foppa, C, Mussini, C, Puoti, M, d'Arminio Monforte, A |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
Pyrrolidines Sustained Virologic Response HIV Infections Adequate prescription Liver disease 0302 clinical medicine Simeprevir Drug–drug interaction Medicine Coinfection Imidazoles Gastroenterology Valine Middle Aged Italy 030220 oncology & carcinogenesis HCV symbols Regression Analysis Drug Therapy Combination Female 030211 gastroenterology & hepatology medicine.drug Drug–drug interactions medicine.medical_specialty Daclatasvir Dose Settore MED/17 - MALATTIE INFETTIVE Antiviral Agents 03 medical and health sciences symbols.namesake Internal medicine Ribavirin Adequate prescription Daclatasvir Drug–drug interactions DAA HCV HIV co-infection Humans HCV NS5A Inhibitor Poisson regression Risk factor Medical prescription Adverse effect Retrospective Studies DAA HIV co-infection Hepatology business.industry Hepatitis C Chronic medicine.disease Carbamates Sofosbuvir business |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|