Within 12 weeks of therapy, dyspnea was observed in 12% of patients in the group receiving the drug Sovriad compared to 8% of cases among the placebo group. All cases of dyspnea in patients receiving the drug Sovriad were mild or moderate severity (1st and 2nd degree). Shortness anadrol of breath 3 or 4 do not arise. Also no patient discontinued treatment due to dyspnoea. 61% of all cases of dyspnea was observed within the first 4 weeks of therapy with Sovriad.
Increased bilirubin concentration
Over 12 weeks of therapy, drug Sovriad increase in bilirubin concentration in the blood have been reported in 7.4% of patients receiving simeprevir compared with 2.8% of patients receiving placebo with peginterferon alfa and ribavirin. Increasing the concentration of bilirubin in the blood of degree 3 or 4 have been reported in 0.3% to 2% of patients taking the drug Sovriad respectively (results of research phase II). Discontinuation of therapy due to an increase simeprevirom bilirubin concentration in blood is rarely needed (0,1%; n = 1).
Increasing direct and indirect bilirubin were mostly mild or moderate severity and reversible bore. Increasing the concentration of bilirubin are not usually accompanied by increased levels of liver transaminases and were due to a decrease in the elimination of bilirubin due to inhibition of transport proteins anadrol hepatocytes under the influence simeprevira. These changes are not considered clinically significant.
Over the 12 weeks of treatment with a drug Sovriad photosensitivity reactions have been reported in 4.7% of patients simeprevira group compared with 0.8% of patients in the placebo group with peginterferon alfa and ribavirin. Most photosensitivity reactions in patients taking the drug Sovriad were mild or moderate severity; 0.1% of patients treated with simeprevir, data were recorded degree of photosensitivity reaction 3. Reaction grade 4 was observed. None of the patients discontinued therapy due to the occurrence of photosensitivity reactions.
Deviations from the laboratory parameters
Differences in the level or amount of hemoglobin and platelet neutrophil registered between groups. Arisen in the course of therapy with a deviation of the laboratory parameters that were recorded with a higher frequency in the treatment of drug Sovriad versus placebo combination with peginterferon alfa and ribavirin, are shown in the table below.
he safety profile of the drug Sovriad in combination with peginterferon alfa and ribavirin of patients with hepatitis C genotype 1 coinfection with HIV-1 (N = 106) and without a comparable.
Information simeprevirom overdose in humans is limited. In single dose simeprevira at doses up to 600 mg or multiple dose at doses up to 400 mg 1 time per day for 5 days in healthy adult volunteers and 200 mg 1 time per day for 4 weeks in adult patients with hepatitis C this drug is usually well tolerated.
A specific antidote is not known. In case of overdose is recommended that a maintenance therapy and monitoring of the patient.
Simeprevir characterized by a high degree of binding to plasma anadrol proteins, therefore hemodialysis with a high degree of probability will not result in a significant removal simeprevira.