|
gptkbp:instanceOf
|
gptkb:brand
gptkb:drug
|
|
gptkbp:activeIngredient
|
gptkb:sofosbuvir
ledipasvir
|
|
gptkbp:approvalYear
|
2014
|
|
gptkbp:approvedBy
|
gptkb:FDA
|
|
gptkbp:ATCCode
|
gptkb:J05AP51
|
|
gptkbp:CASNumber
|
1256388-51-8 (ledipasvir), 1190307-88-0 (sofosbuvir)
|
|
gptkbp:chemicalFormula
|
C49H54N8O8 (ledipasvir), C22H29FN3O9P (sofosbuvir)
|
|
gptkbp:contraindication
|
severe renal impairment
hypersensitivity to ingredients
|
|
gptkbp:cost
|
high
|
|
gptkbp:drugInteraction
|
gptkb:rifampin
gptkb:St._John's_wort
amiodarone
|
|
gptkbp:durationOfTreatment
|
8 to 24 weeks
|
|
gptkbp:firstApprovedCountry
|
gptkb:United_States
|
|
gptkbp:form
|
gptkb:tablet
|
|
gptkbp:genericAvailable
|
yes
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Harvoni
|
|
gptkbp:indication
|
chronic hepatitis C virus infection
genotype 1 hepatitis C
genotype 4 hepatitis C
genotype 5 hepatitis C
genotype 6 hepatitis C
|
|
gptkbp:legalStatus
|
prescription only
|
|
gptkbp:manufacturer
|
gptkb:Gilead_Sciences
|
|
gptkbp:marketedIn
|
gptkb:Australia
gptkb:Canada
gptkb:European_Union
gptkb:Japan
gptkb:United_States
|
|
gptkbp:mechanismOfAction
|
gptkb:NS5B_polymerase_inhibitor_(sofosbuvir)
NS5A inhibitor (ledipasvir)
|
|
gptkbp:patent
|
gptkb:Gilead_Sciences
|
|
gptkbp:pregnancyCategory
|
B1 (Australia)
|
|
gptkbp:prescribes
|
adults
children over 3 years old
|
|
gptkbp:prescriptionRequired
|
yes
|
|
gptkbp:routeOfAdministration
|
oral
|
|
gptkbp:sideEffect
|
nausea
diarrhea
fatigue
headache
insomnia
|
|
gptkbp:successRate
|
over 90% SVR (sustained virologic response)
|
|
gptkbp:usedFor
|
treatment of hepatitis C
|
|
gptkbp:WHOModelListOfEssentialMedicines
|
yes
|
|
gptkbp:bfsParent
|
gptkb:Gilead_Sciences
gptkb:Gilead
|
|
gptkbp:bfsLayer
|
5
|