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Sofosbuvir

Class
Antiviral agents
Subclass
Nucleoside analogs
Substance name
Sofosbuvir
Brand names
Sovaldi®
Common formulations
Film-coated tablet
Contained in
Ledipasvir / sofosbuvir
Sofosbuvir / velpatasvir
Sofosbuvir / velpatasvir / voxilaprevir (Vosevi®)
Dosage and administration
Adults patients
Treatment of chronic hepatitis C infection
•
400 mg PO daily
Indications for use
Labeled indications
Adults
•
Treatment of chronic hepatitis C infection
Children
•
Treatment of HCV infection in patients with chronic HCV infection
Safety risks
Warnings and precautions
Bradycardia
•
Use caution with pre-existing cardiac conditions.
Dysglycemia
•
Use caution with diabetes mellitus.
Hematologic disorder
•
Use caution receiving concurrent anticoagulant therapy.
Reactivation of HBV infection
•
Use caution with a history of HBV infection.
Specific populations
Renal impairment
eGFR 30-50 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR 10-30 mL/min/1.73 m²
•
Use with caution. Maximal dose of 400 mg. Do not exceed frequency of q48h.
eGFR < 10 mL/min/1.73 m²
•
Use with caution. Maximal dose of 400 mg. Do not exceed frequency of q48h.
Renal replacement therapy
Continuous renal replacement
•
Dose as in eGFR 10-30 mL/min/1.73 m². Maximal dose of 400 mg. Maximal frequency of q48h.
Intermittent hemodialysis
•
Maximal dose of 200 mg. Maximal frequency of daily.
Peritoneal dialysis
•
Dose as in eGFR < 10 mL/min/1.73 m². Maximal dose of 400 mg. Maximal frequency of q48h.
Hepatic impairment
Acute or decompensated chronic liver disease
•
No guidance available.
Any severity
•
Use acceptable. No dose adjustment required.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
•
Insufficient evidence. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Monotherapy is not recommended.
•
In certain patient populations, sofosbuvir must be administered with ribavirin, which is contraindicated during pregnancy (FDA pregnancy risk category X) and in females who may become pregnant.
Breastfeeding
Acceptable for use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Unlikely to cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
Anemia, ↓ blood neutrophil count, influenza virus infection, asthenia, diarrhea, fatigue, fever, generalized pruritus, headache, insomnia, irritability, loss of appetite, myalgia, nausea, skin rash, shivering
Common 1-10%
•
↑ serum CK, ↑ serum TBIL, ↑ serum lipase
Uncommon < 1%
•
Depression, suicidal ideation, suicide attempt
Unknown frequency
•
ALF, bradycardia, hepatitis exacerbation, pityriasis rubra pilaris, dry eyes, uveitis
Interactions
Drug(s)
Check Interactions
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