Harvoni

E409697

antiviral medication combination drug direct-acting antiviral prescription drug

Harvoni is a prescription antiviral medication used to treat chronic hepatitis C virus (HCV) infection.

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All labels observed (1)

Label	Occurrences
Harvoni canonical	1

Statements (48)

Predicate	Object
instanceOf	antiviral medication ⓘ combination drug ⓘ direct-acting antiviral ⓘ prescription drug ⓘ
achievesOutcome	sustained virologic response in many patients ⓘ
approvedBy	Food and Drug Administration ⓘ surface form: U.S. Food and Drug Administration
approvedIn	European Union ⓘ United States of America ⓘ surface form: United States
canBeUsedIn	HIV/HCV coinfected patients ⓘ
contraindicatedWith	St John’s wort ⓘ surface form: St. John’s wort rifampin ⓘ strong P-glycoprotein inducers ⓘ
developedBy	Gilead Sciences (board member) ⓘ surface form: Gilead Sciences
hasActiveIngredient	ledipasvir ⓘ Sovaldi ⓘ surface form: sofosbuvir
hasATCCode	J05AX65 ⓘ
hasBlackBoxWarning	risk of hepatitis B virus reactivation in coinfected patients ⓘ
hasCommonAdverseEffect	diarrhea ⓘ fatigue ⓘ headache ⓘ insomnia ⓘ nausea ⓘ
hasDosageForm	film-coated tablet ⓘ
hasLegalStatus	prescription-only ⓘ
hasPregnancyCategory	use only if potential benefit justifies potential risk ⓘ
hasRouteOfAdministration	oral ⓘ
hasRouteOfElimination	biliary excretion ⓘ renal excretion of sofosbuvir metabolites ⓘ
hasTarget	HCV NS5A protein ⓘ HCV NS5B RNA-dependent RNA polymerase ⓘ
indicatedFor	adult patients with chronic hepatitis C ⓘ patients with cirrhosis ⓘ patients with compensated liver disease ⓘ pediatric patients with chronic hepatitis C ⓘ
mechanismOfAction	NS5A inhibitor activity via ledipasvir ⓘ NS5B polymerase inhibitor activity via sofosbuvir ⓘ
metabolizedBy	not significantly via CYP450 enzymes ⓘ
oftenCoAdministeredWith	ribavirin ⓘ
regimenType	interferon-free ⓘ
takenOnce	daily ⓘ
treats	chronic hepatitis C virus infection ⓘ hepatitis C genotype 1 ⓘ hepatitis C genotype 4 ⓘ hepatitis C genotype 5 ⓘ hepatitis C genotype 6 ⓘ
typicalTreatmentDuration	12 weeks ⓘ 24 weeks ⓘ 8 weeks ⓘ

Referenced by (1)

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

Gilead Sciences (board member) → product → Harvoni ⓘ

subject surface form: Gilead Sciences