possibilities [1%):99.9% (albumin and alpha 1-acid glycoprotein) Special Populations: Hepatic Function Impairment Mean steady-state AUC of simeprevir was 2.4-fold higher in HCV-uninfected subjects with moderate hepatic impairment (Child-Pugh class B) and 5.2-fold higher in HCV-uninfected subjects with severe hepatic impairment (Child-Pugh class C) compared with HCV-uninfected subjects with normal hepatic function. Use: Labeled Indications Chronic hepatitis C: Treatment of genotype 1 chronic hepatitis C in combination with peginterferon alfa and ribavirin or sofosbuvir in adults without cirrhosis or with compensated cirrhosis. Limitations of use: Not recommended for use in patients who have previously failed a simeprevir-containing regimen or another regimen containing HCV protease inhibitors. Contraindications There are no contraindications listed in the manufacturer's labeling. When administered with ribavirin and peginterferon alfa, the contraindications to ribavirin and peginterferon alfa also apply. See Ribavirin and Peginterferon Alfa monographs. Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to simeprevir or any component of the formulation Dosing: Adult Note: If other concomitant treatment (sofosbuvir or peginterferon and ribavirin) is discontinued for any reason, simeprevir must also be discontinued. Do not reduce simeprevir dosage or interrupt therapy; if therapy must be interrupted due to adverse reactions or inadequate response, do not reinitiate. In patients with genotype 1a and compensated cirrhosis, screening for HCV with the NS3 Q80K polymorphism may be considered prior to starting therapy. Screening is strongly recommended prior to initiation of combination treatment with peginterferon alfa and ribavirin in patients with genotype 1a; consider alternative therapy in patients infected with HCV genotype 1a containing the Q80K polymorphism. Chronic hepatitis C (CHC): Oral: Note: Treatment-experienced includes prior relapse patients, prior partial responders, and prior null responders who have failed previous interferon-based therapy. Combination with sofosbuvir: Genotype 1, treatment-naive or treatment-experienced: Patients without cirrhosis: 150 mg once daily in combination with sofosbuvir for 12 weeks. Patients with compensated cirrhosis (Child-Pugh class A): 150 mg once daily in combination with sofosbuvir for 24 weeks. Note: This regimen should only be used in genotype 1a patients who are negative for the Q80K polymorphism. Guidelines also recommend that the addition of ribavirin may be considered in genotype 1a and 1b patients with compensated cirrhosis (AASLD/IDSA 2016). Combination with peginterferon alfa and ribavirin: Note: Combination therapy with peginterferon and ribavirin is not recommended in HCV treatment guidelines, regardless of genotype or treatment status (eg, treatment-naive or treatment-experienced) (AASLD/IDSA 2016). Genotype 1, treatment-naive or prior relapse patients (patients without cirrhosis or with compensated cirrhosis (Child-Pugh class A) who are mono-infected and patients without cirrhosis who are co-infected with HIV-1): Note: Prior relapsers include patients with an undetectable HCV-RNA upon completion of treatment (prior interferon-based regimen) but with detectable HCV-RNA during the follow-up period. 150 mg once daily in combination with peginterferon alfa and ribavirin for 12 weeks, followed by an additional 12 weeks of peginterferon alfa and ribavirin (total treatment duration of 24 weeks). Genotype 1, treatment-naive or prior relapse patients with compensated cirrhosis (Child-Pugh class A) who are co-infected with HIV-1: Note: Prior relapsers include patients with an undetectable HCV-RNA upon completion of treatment (prior interferon-based regimen) but with detectable HCV-RNA during the follow-up period. 150 mg once daily in combination with peginterferon alfa and ribavirin for 12 weeks, followed by an additional 36 weeks of peginterferon alfa and ribavirin (total treatment duration of 48 weeks). Genotype 1, previously treated mono-infected or HCV/HIV-1 co-infected patients (partial response or null responders) without cirrhosis or with compensated cirrhosis (Child-Pugh class A): Note: Partial response includes patients with a 2 log 10 HCV-RNA decrease at week 12 but detectable HCV-RNA at the end of prior interferon-based therapy. Prior null responders include patients with a] Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Simeprevir Rating 4 User Reviews 9.7 /10 4 User Reviews 9.7 Rate it! Drug Class Protease inhibitors Related Drugs protease inhibitors Norvir , Prezista , Reyataz , ritonavir , darunavir , Kaletra Hepatitis C Harvoni , Epclusa , ribavirin , Zepatier , Mavyret , Sovaldi , sofosbuvir , ledipasvir / sofosbuvir , Vosevi , Viekira Pak , daclatasvir , Daklinza , Pegasys , Intron A , Ribasphere , Olysio , sofosbuvir / velpatasvir , Rebetol , Moderiba , PegIntron , elbasvir / grazoprevir , glecaprevir / pibrentasvir , RibaPak , More... try to be
finally Simeprevir is still
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