sofosbuvir + velpatasvir: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
sofosbuvir + velpatasvir: clinical details
Prescribing considerations
- Initiate and monitor through a clinician experienced in hepatitis C management.
- Reconcile prescribed, non-prescribed, recreational and herbal products before treatment and when medicines change.
- Assess prior antiviral exposure, cirrhosis status, renal function, hepatitis B status and relevant HIV therapy.
- Severe renal impairment and dialysis have more limited safety data and require specialist assessment.
- Do not administer alongside another sofosbuvir-containing product.
Contraindications and cautions
- Hypersensitivity to either active substance or a formulation excipient.
- Concurrent strong P-glycoprotein or strong CYP inducers, including carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St John’s wort.
Monitoring
- HCV RNA and relevant liver tests before, during and after treatment to assess response.
- Screen for hepatitis B before initiation; monitor and manage HBV/HCV co-infection because reactivation can occur.
- Monitor glucose closely in patients with diabetes, particularly early in treatment.
- Monitor INR with vitamin K antagonists and drug concentrations or toxicity where clinically relevant interactions exist.
- Continue appropriate liver surveillance after viral clearance in patients with cirrhosis.
Clinical pharmacology
Sofosbuvir is a nucleotide prodrug converted intracellularly to an NS5B polymerase chain terminator. Velpatasvir inhibits NS5A. Both are P-glycoprotein and BCRP substrates; velpatasvir also inhibits P-glycoprotein, BCRP and OATP1B transporters.
Formulation and product differences
- Film-coated tablets should be swallowed whole because crushing or chewing exposes a bitter taste.
- Coated granules provide an option for children or others who have difficulty swallowing tablets.
- Granules may be taken directly, with water or with non-acidic soft food; they should not be chewed.
- The selected granule formulation contains lactose.
sofosbuvir + velpatasvir preparations and strengths
Tablet
Route: Oral
Strengths: 200 mg + 50 mg, 400 mg + 100 mg
sofosbuvir + velpatasvir interactions
A full medication review is essential because some combinations can reduce antiviral exposure or increase toxicity.
Carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St John’s wort
These combinations are contraindicated because they can substantially reduce antiviral exposure.
Efavirenz, modafinil, oxcarbazepine or rifapentine
These may lower sofosbuvir or velpatasvir exposure and co-administration is not recommended.
Amiodarone
Can cause serious symptomatic bradycardia or heart block. Use only when alternatives are unsuitable, with specialist cardiac monitoring.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.