Compared with patients without chronic hepatitis C with normal renal function (the classified using a formula diet modifications in renal disease anadrol dosage for calculating glomerular filtration rate;? Estimated glomerular filtration rate of 80 ml / min), the average values of simeprevira in equilibrium at patients without chronic hepatitis C infection and severe violation of renal function (glomerular filtration rate of less than 30 ml / min) were 62% higher. Based on the study and expected changes simeprevira concentration in plasma, does not require dose adjustment Sovriad drug in patients with impaired renal function mild, moderate and severe.
The efficacy and safety Sovriad the drug has not been studied in patients with chronic hepatitis with impaired renal function, severe or end-stage renal failure, including patients requiring hemodialysis.
According to the results of a population pharmacokinetic analysis in patients with impaired mild or moderate renal function during therapy Sovriad drug at a dose of 150 mg 1 time per day, creatinine clearance did not influence the pharmacokinetic parameters simeprevira. Thus, clinically significant effect breach mild or moderate renal function simeprevira concentration is expected. Since simeprevir is largely bound to plasma proteins, removing a significant amount of the drug by hemodialysis is unlikely.
Information on treatment with peginterferon alfa and ribavirin in patients with renal impairment, refer to the respective instructions for use.
Patients with impaired hepatic function
Simeprevir metabolized primarily in the liver.
plasma concentration simeprevira patients with hepatitis C was 2-3 times higher than that in healthy volunteers.
Compared with healthy volunteers with normal function of the liver in hepatitis C patients without violation average degree of liver function anadrol dosage simeprevira average value at steady state was 2.4 times higher, while in patients without hepatitis C with impaired liver function, severe , it was higher by 5.2 times. No dose adjustment Sovriad preparation is not required in patients with impaired hepatic function mild . In patients with hepatitis C with moderate or severe liver function simeprevira safety and efficacy have not been studied. In clinical trials, an increase in the blood concentration of simeprevira caused an increase in the incidence of adverse events, including rash and photosensitivity. For patients with impaired liver function moderate to severe, there are no recommendations for dose adjustment simeprevira. The potential benefits and risks of the drug Sovriad should be carefully evaluated prior to use in patients with impaired liver function moderate or severe.
Based on a population pharmacokinetic analysis in patients with hepatitis C, thus providing drug Sovriad, stage of liver fibrosis has no clinically meaningful effect on the pharmacokinetics of simeprevira.
Information on treatment with peginterferon alfa and ribavirin is given in the respective instructions for use.
Other groups of patients
No dose adjustment based on gender, body weight or body mass index is not required. Based on a population pharmacokinetic analysis in infected hepatitis C virus patients receiving drug Sovriad, these characteristics do not have a clinically meaningful effect on the pharmacokinetics of simeprevira.
Patients with co-infection of HIV-1
Parameters simeprevira pharmacokinetics in patients with hepatitis C genotype 1 HCV coinfections with HIV-1 or without were comparable.
According to studies in patients without hepatitis C and in patients with hepatitis C, simeprevira concentration in the blood plasma of patients anadrol dosageraces were higher than those of Caucasian patients. In Phase 3 studies, when receiving Sovriad the drug at a dose of 150 mg 1 time per day the average concentration in the Mongoloid race simeprevira patients was 3.4 times higher compared to all other patients. In clinical studies, higher concentrations in the blood simeprevira induced an increase in the incidence of adverse events, including rash and photosensitivity. The available safety data are insufficient to provide any recommendations for East Asian origin of the patients.
The potential benefits and risks of the drug Sovriad should be carefully evaluated before use in patients of East Asian origin.
Population pharmacokinetic analysis showed that plasma concentrations were comparable simeprevira in Caucasian patients with hepatitis C patients and blacks with hepatitis C. how much to inject for weight loss
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