Sovaldi

E411074

Sovaldi is a breakthrough antiviral medication used to treat chronic hepatitis C by directly inhibiting the virus’s replication.

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All labels observed (3)

Label Occurrences
sofosbuvir 2
Sofosbuvir 1
Sovaldi canonical 1

Statements (49)

Predicate Object
instanceOf antiviral medication
direct-acting antiviral
hepatitis C drug
approvedBy Food and Drug Administration
surface form: U.S. Food and Drug Administration
approvedIn European Union
United States of America
surface form: United States
belongsToClass nucleotide analog polymerase inhibitors
boxedWarning risk of hepatitis B virus reactivation in coinfected patients
commonAdverseEffect fatigue
headache
insomnia
nausea
contraindicatedWith amiodarone (relative contraindication due to bradycardia risk)
developedBy Gilead Sciences (board member)
surface form: Gilead Sciences
dosageForm film-coated tablet
eliminationHalfLife approximately 0.4 hours for sofosbuvir
approximately 27 hours for main metabolite GS-331007
FDAApprovalDate 2013-12-06
hasActiveIngredient sofosbuvir
hasATCCode J05AX15
hasBreakthroughDesignation yes (for certain HCV indications)
hasGenericName Sovaldi self-linksurface differs
surface form: sofosbuvir
hasMechanismOfAction NS5B RNA-dependent RNA polymerase inhibition
indicatedFor treatment of chronic hepatitis C in adults
treatment of chronic hepatitis C in pediatric patients 3 years and older
inhibits HCV NS5B RNA-dependent RNA polymerase
surface form: HCV NS5B polymerase
isFirstInClass one of the first highly effective oral DAAs for HCV
isProdrugOf sofosbuvir triphosphate
marketedBy Gilead Sciences (board member)
surface form: Gilead Sciences
metabolizedTo GS-461203 (active triphosphate)
patentHolder Gilead Sciences (board member)
surface form: Gilead Sciences
pregnancyCategoryUS B
requiresMonitoring HBV coinfection status
hepatic function
routeOfAdministration oral
seriousAdverseEffect severe bradycardia with amiodarone coadministration
takenWithFood may be taken with or without food
treats chronic hepatitis C virus infection
hepatitis C genotype 1
hepatitis C genotype 2
hepatitis C genotype 3
hepatitis C genotype 4
hepatitis C genotype 5
hepatitis C genotype 6
typicalDose 400 mg once daily in adults
usedInCombinationWith daclatasvir
ledipasvir
peginterferon alfa
ribavirin

Referenced by (4)

Full triples — surface form annotated when it differs from this entity's canonical label.

Gilead Sciences (board member) product Sovaldi
subject surface form: Gilead Sciences
velpatasvir usedWith Sovaldi
subject surface form: Velpatasvir
this entity surface form: Sofosbuvir
Harvoni hasActiveIngredient Sovaldi
this entity surface form: sofosbuvir
Sovaldi hasGenericName Sovaldi self-linksurface differs
this entity surface form: sofosbuvir