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Indications

REMS


Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

In combination with ribavirin

Derm: pruritus

GI: diarrhea, HBV reactivation, nausea

MS: myalgia

Neuro: fatigue, headache, insomnia, irritability, weakness

Misc: chills, fever

In combination with ribavirin and peginterferon alfa

Derm: rash, pruritus

GI: diarrhea, nausea, HBV reactivation

Hemat: anemia

MS: myalgia

Neuro: fatigue, headache, insomnia, irritability, weakness

Misc: chills, fever

Interactions

Drug-drug:

Drug-Natural Products:

Availability

(Generic available)

Route/Dosage

US Brand Names

Sovaldi

Action

  • Inhibits RNA-dependent RNA polymerase, resulting in inhibition of viral replication.
Therapeutic effects:
  • Decreased HCV RNA levels with decreased severity and sequelae of HCV.

Classifications

Therapeutic Classification: antivirals

Pharmacologic Classification: polymerase inhibitors

Pharmacokinetics

Absorption: Rapidly absorbed following oral administration.

Distribution: Unknown.

Metabolism/Excretion: Extensively metabolized with much conversion to GS-461203, an active antiviral moiety, then converted GS-331007, which does not have antiviral activity. 80% excreted in urine mostly as GS-331007 (3.5% as unchanged drug), 14% excreted in feces, 2.5% excreted in expired air.

Half-Life: Sofosbuvir: 0.4 hr; GS-331007: 27 hr.

Time/Action Profile

(plasma concentrations)

ROUTEONSETPEAKDURATION
POunknown0.5–2 hr24 hr

Sofosbuvir (2–4 hr for GS-331007).



Patient/Family Teaching

Pronunciation

soe-FOS-bue-vir