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 |
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.
subject surface form:
Gilead Sciences
subject surface form:
Velpatasvir
this entity surface form:
Sofosbuvir
this entity surface form:
sofosbuvir
this entity surface form:
sofosbuvir