Direct-acting antiviral (NS5B inhibitor) Pregnancy: Limited data; as a precautionary measure, it is preferable to avoid use during pregnancy. When co-administered with ribavirin, ribavirin's pregnancy contraindications apply (significant teratogenic/embryocidal effects) - effective contraception is required in female patients and female partners of male patients.

Sofosbuvir

Brand names: Sovaldi

Sofosbuvir is a direct-acting antiviral nucleotide analogue used, in combination with other agents, to treat chronic hepatitis C virus infection.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 400 mg (one tablet)

Route: Oral

Frequency: Once daily, with food

For chronic hepatitis C (CHC), initiated and monitored by a physician experienced in CHC management. Use in combination with other medicinal products (e.g. ribavirin with or without peginterferon alfa); monotherapy is not recommended. Co-administered products and treatment duration depend on genotype: e.g. genotype 1/4/5/6 - + ribavirin + peginterferon alfa for 12 weeks, or + ribavirin for 24 weeks if peginterferon-ineligible/intolerant; genotype 2 - + ribavirin for 12 weeks; genotype 3 - + ribavirin + peginterferon alfa for 12 weeks or + ribavirin for 24 weeks; awaiting liver transplantation - + ribavirin until transplantation. Dose reduction of sofosbuvir is not recommended. Paediatric (aged 3 years and above, weight-based): 35 kg and over = 400 mg once daily; 17 to <35 kg = 200 mg once daily; tablets not recommended if under 17 kg (oral granules available) - verify against a children's formulary.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to sofosbuvir or to any of the excipients
Strong intestinal P-glycoprotein (P-gp) inducers - carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort (significantly decrease sofosbuvir plasma concentration and could cause loss of efficacy)

Side effects

Fatigue
Headache
Nausea
Insomnia
Anaemia / decreased haemoglobin; decreased appetite (in combination regimens; no adverse reactions specific to sofosbuvir identified)

Interactions

Amiodarone: risk of severe, potentially life-threatening bradycardia and heart block - avoid; if concomitant use is necessary, cardiac monitoring is required
Strong P-glycoprotein inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort): contraindicated - reduce sofosbuvir exposure and efficacy

Clinical monograph

How it works

Its active metabolite inhibits the hepatitis C NS5B RNA-dependent RNA polymerase, terminating viral RNA replication.

Prescribing in practice

Co-administration with amiodarone can cause severe symptomatic bradycardia and is generally avoided.
It is always used as part of a combination regimen, never as monotherapy.
Potent enzyme inducers such as certain anticonvulsants and rifampicin can substantially lower its levels and are contraindicated.

Monitoring

Monitor hepatitis C viral load to confirm sustained virological response and assess hepatic function during treatment.

Counselling the patient

Take the full course exactly as prescribed to clear the infection.
Tell your clinician if you take amiodarone for heart rhythm problems.
Avoid starting new medicines without checking, as some reduce this treatment's effectiveness.

Evidence & guidelines

Sofosbuvir-based regimens achieve high cure rates in chronic hepatitis C and are recommended in NICE guidance.

Reference: NICE TA330; BHIVA/EASL; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways