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Indications

REMS

Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

CNS: fatigue, headache, insomnia.

GI: diarrhea, nausea, hepatitis B virus reactivation, hyperbilirubinemia.

Interactions

Drug-Drug:

Drug-Natural Products:

Availability

Route/Dosage

US Brand Names

Vosevi

Action

Therapeutic Effects:

Classifications

Therapeutic Classification: antivirals

Pharmacologic Classification: NS5A inhibitors, protease inhibitors

Pharmacokinetics

Sofosbuvir

Absorption: Prodrug that is rapidly metabolized to its active form (GS-461203) following absorption.

Distribution: Unknown.

Metabolism/Excretion: Extensively metabolized primarily to GS-461203, an active antiviral moiety, then converted to GS-331007, which does not have antiviral activity. 80% excreted in urine mostly as GS-331007, 14% excreted in feces.

Half-life: Sofosbuvir — 0.5 hr; GS-331007 — 29 hr.

Velpatasvir

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Protein Binding: >99%.

Metabolism/Excretion: Metabolized in the liver primarily via CYP2B6, CYP2C8, and CYP3A4. Primarily undergoes biliary excretion, with 94% excreted in feces (77% as unchanged drug) and 0.4% eliminated in urine.

Half-life: 17 hr.

Voxilaprevir

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Protein Binding: >99%.

Metabolism/Excretion: Metabolized in the liver primarily via CYP3A4. Primarily undergoes biliary excretion, with 94% excreted in feces (40% as unchanged drug) and 0% eliminated in urine.

Half-life: 33 hr.

Time/Action Profile

(blood levels)

ROUTEONSETPEAKDURATION
sofosbuvir (PO)unknown2 hr24 hr
velpatasvir (PO)unknown4 hr24 hr
voxilaprevir (PO)unknown4 hr24 hr

Patient/Family Teaching

Pronunciation

soe-FOS-bue-vir/vel-PAT-as-vir/vox-i-LA-pre-vir