sofosbuvir + velpatasvir + voxilaprevir: clinical use

Prescribing considerations

• Initiate and monitor through a clinician experienced in managing hepatitis C.
• Assess previous direct-acting antiviral exposure, cirrhosis status, hepatic function, renal function, age and weight eligibility.
• Complete a full prescription, non-prescription and herbal interaction review.
• Safety data are limited in severe renal impairment and end-stage renal disease; use requires careful benefit–risk assessment where other relevant options are unavailable.
• Safety and efficacy after liver transplantation have not been established.

Contraindications and cautions

• Hypersensitivity to an active substance or excipient.
• Strong P-gp or CYP inducers, including carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St John’s wort.
• Rosuvastatin.
• Dabigatran etexilate.
• Ethinylestradiol-containing products.

Monitoring

• Check hepatitis C virological response with blood tests before, during and after treatment.
• Screen everyone for hepatitis B before treatment and monitor co-infected patients for reactivation.
• Monitor blood glucose closely in people with diabetes, particularly early in treatment, as improved viral control can precipitate hypoglycaemia.
• Monitor INR with vitamin K antagonists and renal safety when relevant tenofovir-containing regimens are used.
• Arrange intensive cardiac monitoring if concurrent amiodarone cannot be avoided.

Clinical pharmacology

Sofosbuvir is an intracellularly activated nucleotide prodrug inhibiting NS5B polymerase; velpatasvir inhibits NS5A; voxilaprevir reversibly inhibits NS3/4A protease. Velpatasvir and voxilaprevir also inhibit transporters including P-gp, BCRP and OATP1B, accounting for important interactions.

Formulation and product differences

• The selected product is a beige, capsule-shaped film-coated fixed-combination tablet.
• It contains lactose monohydrate.
• The tablet should be swallowed whole with food and protected from moisture in its original packaging.

Tablet

Route: Oral

Strengths: 400 mg + 100 mg + 100 mg