Zepatier is dosed one tablet taken orally with or without ________ .
What is food
100
Zepatier is contraindicated this HIV Medication. Name (1)
What is Efavirenz, Atanzanavir, Darunavir, Loprinavir, Saquinavir, Tipranavir
100
Zepatier has been studied in pregnancy and poses no risk to pregnancy outcomes.
TRUE or FALSE
What is FALSE
100
Name the clinical trial(s) demonstrating Zepatier efficacy in treatment naïve subjects with Genotype 1 HCV.
Name (1)
What is C-Edge TN and C-Edge Coinfection
200
Zepatier contains a combination of which two products?
What is Elbasivir and Grazoprevir
200
Describe a patient population where Zepatier is dosed for 16 weeks with ribavirin
What is Genotype 1A: Treatment naïve or Peg/IFN/ RBV exp WITH baseline NS5A polymorphisms
OR
Genotype 4: PegIFN/RBV experienced
200
During clinical trials with Zepatier with or without ribavirin,
_____% of subjects experienced elevations of ALT from normal levels to greater than 5 times the upper limit of normal (ULN), generally at or after treatment week 8.
What is 1%
200
There is dose adjustment recommended in Asians and women
TRUE or FALSE
What is False
200
How many study subjects were in the C-Edge TN - Zepatier 12 weeks?
What is 288
300
Elbasavir is a hepatitis C virus HCV _______ inhibitor
What is NS5A inhibitor
300
What is the shortest duration of treatment with Zepatier?
What is 12 weeks
300
The safety of Zepatier was assessed based in approximately _______ study subjects.
What is 1700
300
No dosage adjustment of Zepatier is recommended in patients with any degree of renal impairmentincluding patients receiving _________________ .
What is hemodialysis
300
In the C edge study what was the SVR in Genotype 1 at 12 weeks?
What is 95% ( 273/288)
400
Grazoprevir is an __________ protease inhibitor.
What is HCV NS3/4A
400
Is there a dose adjustment recommended in Renal impairment, including hemodialysis?
What is NO
400
Adverse Reactions ( all intensity) reported in >=5% of treatment naïve subjects with HCV treated with Zepatier for 12 weeks in the C-Edge TN
What is Fatigue and Nausea
400
No dose adjustment is recommended in patients with mild hepatic impairment ( Child- Pugh A).
TRUE or FALSE
What TRUE
400
In the C-Edge treatment naïve studies which genotype achieved a 98% SVR
What is GT 1b
500
Zepatier is indicated with or without ________ for treatment of chronic HCV genotypes1 or 4infectionin adults.
What is Ribavirn
500
Name one test recommended prior to therapy.
What is Genotype 1a testing for the presence of virus with NS5A resistance-associated polymorphisms.
500
Hepatic laboratory testing should be performed prior to therapy, at treatment week 8, and as clinically indicated.
True or False
What is True
500
Clinical trials of Zepatier with or without ribavirin included 187 subjects aged ______ years and over.
What is 65
500
The were cirrhotic and non-cirrhotic study subjects included in the C-Edge TN and Co-Infection studies?
True or False