sofosbuvir: clinical use

Prescribing considerations

• Initiate and monitor treatment under a clinician experienced in chronic hepatitis C management.
• Use only as part of an appropriate combination; monotherapy is not recommended.
• Review the entire regimen, comorbidities and interaction profile, including non-prescription and herbal products.
• Assess renal function and companion-medicine suitability; safety data for severe renal impairment and dialysis are limited.
• Review other liver disease, transplant status and decompensated cirrhosis; efficacy and safety are not established in decompensated cirrhosis.

Contraindications and cautions

• Hypersensitivity to sofosbuvir or a formulation excipient.
• Concomitant carbamazepine, phenobarbital, phenytoin, rifampicin or St John’s wort.

Monitoring

• Screen for hepatitis B before treatment; monitor HCV/HBV co-infection for reactivation.
• Measure virological response during and after treatment as clinically appropriate.
• Monitor blood glucose closely after starting treatment in people with diabetes.
• Monitor INR more closely in patients taking vitamin K antagonists.
• Arrange cardiac monitoring when concurrent or recent amiodarone exposure cannot be avoided.
• Apply monitoring required by companion medicines, including haematological monitoring where relevant.

Clinical pharmacology

Sofosbuvir is a nucleotide prodrug and P-glycoprotein/BCRP substrate. Its active intracellular metabolite inhibits HCV NS5B RNA-dependent RNA polymerase by RNA-chain termination.

Formulation and product differences

• Film-coated tablets should be swallowed whole with food and not split, crushed or chewed.
• Coated granules may be swallowed directly, with water or after mixing with non-acidic soft food; they must not be chewed.
• The granule formulation contains lactose; the selected tablet and granule products are essentially sodium-free.

Tablet

Route: Oral

Strengths: 400 mg