Background and Aims: Direct-acting Antiviral Agents (DAAs) have shown a high rate of Sustained Virologic Response (SVR) in the treatment of hepatitis C, with few and mild adverse reactions. The aim of this study was to evaluate: (1) The efficacy of DAAs; (2) The incidence of adverse reactions; (3) The interactions with other drugs in our centre. Method: We performed an observational study of all HCV patients treated with DAAs in our centre from 01/01/2015 to 01/08/2017. We recorded: patient demographic information, grade of fibrosis by point-ShearWave Elastography on Philips IU22 before and 12 months after treatment, HCV genotype, DAAs adverse reactions and therapeutic scheme, and concomitant drugs. Results: We treated 142 HCV consecutive patients with second generation DAAs. We obtained a Sustained Virologic Response at 12 weeks (SVR12) in 93.5% of patients, 9 failures and 3 treatment interruptions due to adverse effects. Only 3 patients did not showany adverse reaction. In almost half of the cases fatigue and a reduction of at least 2 g/dL of haemoglobin levels were observed. Another frequent adverse effect was hyperglycemia (31.7%), observed in around 70% of the patients with type 2 diabetes treated with insulin or oral hypoglicemic agents and only in 25% of the non-diabetic patients. Hyperglycemia was more frequent in patients taking Daclatasvir + Sofosbuvir (45.7% vs 31.7% – p < 0.001) without a correlation with a specific antidiabetic drugs. Moreover, higher degrees of fibrosis were associated with a higher number of adverse reactions (p < 0.001). Patients who take Ribavirin display a high rate of anaemia also present with only DAA, even if less severe (67% vs 28% – p < 0.001). Conclusion: In this real life study, DAAs confirmed the excellent therapeutic success already known in literature. However,we found a higher rate of adverse effects especially in more advanced liver disease. In particular we have noticed a relevant rate of hyperglycemia, an adverse effect that has not been reported in literature and that appears to be related to the drug’s class or the hepatic effect of HCV clearance rather than drug-drug interactions.

Adverse reactions of direct-acting antiviral agents in HCV patients: Our experience

PADOVANI, DIANA;F. Masutti;Riccardo Patti;M. R. Buonocore;Daniele Macor;P Schincariol;S. L. Croce
2018

Abstract

Background and Aims: Direct-acting Antiviral Agents (DAAs) have shown a high rate of Sustained Virologic Response (SVR) in the treatment of hepatitis C, with few and mild adverse reactions. The aim of this study was to evaluate: (1) The efficacy of DAAs; (2) The incidence of adverse reactions; (3) The interactions with other drugs in our centre. Method: We performed an observational study of all HCV patients treated with DAAs in our centre from 01/01/2015 to 01/08/2017. We recorded: patient demographic information, grade of fibrosis by point-ShearWave Elastography on Philips IU22 before and 12 months after treatment, HCV genotype, DAAs adverse reactions and therapeutic scheme, and concomitant drugs. Results: We treated 142 HCV consecutive patients with second generation DAAs. We obtained a Sustained Virologic Response at 12 weeks (SVR12) in 93.5% of patients, 9 failures and 3 treatment interruptions due to adverse effects. Only 3 patients did not showany adverse reaction. In almost half of the cases fatigue and a reduction of at least 2 g/dL of haemoglobin levels were observed. Another frequent adverse effect was hyperglycemia (31.7%), observed in around 70% of the patients with type 2 diabetes treated with insulin or oral hypoglicemic agents and only in 25% of the non-diabetic patients. Hyperglycemia was more frequent in patients taking Daclatasvir + Sofosbuvir (45.7% vs 31.7% – p < 0.001) without a correlation with a specific antidiabetic drugs. Moreover, higher degrees of fibrosis were associated with a higher number of adverse reactions (p < 0.001). Patients who take Ribavirin display a high rate of anaemia also present with only DAA, even if less severe (67% vs 28% – p < 0.001). Conclusion: In this real life study, DAAs confirmed the excellent therapeutic success already known in literature. However,we found a higher rate of adverse effects especially in more advanced liver disease. In particular we have noticed a relevant rate of hyperglycemia, an adverse effect that has not been reported in literature and that appears to be related to the drug’s class or the hepatic effect of HCV clearance rather than drug-drug interactions.
https://www.sciencedirect.com/science/article/pii/S0168827818307918?via=ihub
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11368/2935705
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