Nurses Compass
Drug Guide
Sofosbuvir
Classification
Therapeutic: Antiviral for hepatitis C
Pharmacological: RNA polymerase inhibitor
FDA Approved Indications
- Chronic hepatitis C virus (HCV) infection, genotype 1, 2, 3, 4, 5, and 6
Mechanism of Action
Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase, which inhibits viral replication.
Dosage and Administration
Adult: 400 mg once daily with or without food, often in combination with other antivirals.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dose adjustment required, but assess renal and hepatic function.
Renal Impairment: Use caution; dose adjustment may be necessary, especially in severe impairment.
Hepatic Impairment: Use in patients with decompensated cirrhosis only as part of combination therapy under specialist supervision.
Pharmacokinetics
Absorption: High oral bioavailability, peak plasma concentration in about 0.8 hours.
Distribution: Wide tissue distribution.
Metabolism: Primarily hepatic via CYP2B and CYP2C8 pathways to active metabolites.
Excretion: Primarily via feces, with some renal excretion.
Half Life: Approximately 0.4 hours for the parent drug, but active metabolites have half-lives of 27 hours.
Contraindications
- Hypersensitivity to sofosbuvir or any component.
- Concurrent use with dasabuvir or with potent organic anion transporting polypeptide (OATP) inhibitors, unless guidance indicates safety.
Precautions
- Monitor for liver function, and be cautious in patients with severe renal impairment or ESRD. Use cautiously in renal impairment.
Adverse Reactions - Common
- Fatigue (Likely)
- Headache (Likely)
- Nausea (Likely)
- Insomnia (Uncommon)
Adverse Reactions - Serious
- Cardiovascular events (rare) (Rare)
- Lactic acidosis (rare) (Rare)
- Hepatic decompensation or worsening liver function (especially in decompensated cirrhosis) (Rare)
Drug-Drug Interactions
- Ribavirin, ledipasvir, daclatasvir, simeprevir, other NS5B inhibitors.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor liver function tests, renal function, and for side effects.
Diagnoses:
- Risk for hepatic decompensation
- Knowledge deficit regarding medication administration
Implementation: Ensure adherence to combination regimens, assess for drug interactions.
Evaluation: Monitor viral load and liver function tests to assess efficacy.
Patient/Family Teaching
- Take medication as prescribed, with or without food.
- Report symptoms of fatigue, nausea, or worsening jaundice.
- Attend regular follow-up appointments.
Special Considerations
Black Box Warnings:
- Use with caution in patients with severe renal impairment or ESRD. Not approved for use in patients with decompensated cirrhosis in monotherapy.
Genetic Factors: None specified.
Lab Test Interference: May cause transient elevations in liver enzymes; monitor accordingly.
Overdose Management
Signs/Symptoms: N/A — limited data, but overdose may cause increased side effects.
Treatment: Supportive care; no specific antidote.
Storage and Handling
Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).
Stability: Stable under recommended storage conditions up to the expiration date.