Sovaldi

E411074

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

All labels observed (3)

Label Occurrences
sofosbuvir 2
Sofosbuvir 1
Sovaldi canonical 1

How this entity was disambiguated

Statements (49)

Predicate Object
instanceOf antiviral medication
direct-acting antiviral
hepatitis C drug
approvedBy U.S. Food and Drug Administration
approvedIn European Union
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
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 sofosbuvir
linked to: Sovaldi
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 polymerase
isFirstInClass one of the first highly effective oral DAAs for HCV
isProdrugOf sofosbuvir triphosphate
marketedBy Gilead Sciences
metabolizedTo GS-461203 (active triphosphate)
patentHolder 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

How these facts were elicited

Referenced by (4)

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

Gilead Sciences product Sovaldi
subject linked to: Gilead Sciences (board member)
Velpatasvir usedWith Sofosbuvir
subject linked to: velpatasvir
linked to: Sovaldi
Harvoni hasActiveIngredient sofosbuvir
linked to: Sovaldi
Sovaldi hasGenericName sofosbuvir
linked to: Sovaldi