Sofosbuvir

Pronunciation: so-FOS-bue-veer.

Generic name: sofosbuvir
Brand names: SOVALDI
Drug class: Nucleotide analog inhibitor of hepatitis C virus (HCV) NS5B polymerase
Form: Tablet
Route: Oral
Legal status: Not established from the sources reviewed: verified only from US FDA DailyMed label in this pass; country-specific legal/dispensing status outside the US is not established from the sources reviewed.

Availability and supply rules vary by country

Trade names by country: United States · Canada

What sofosbuvir is and how it works

Sofosbuvir is a direct-acting antiviral that inhibits the hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase. It is used only as part of a combination antiviral regimen for chronic hepatitis C. (1)

Approved for adults with HCV genotypes 1-4 and for children aged 3 years and older with genotypes 2-3, always in combination with other HCV medicines. Treatment duration and specific combination partners depend on genotype, prior treatment history, and local prescribing information. All patients must be tested for hepatitis B infection before starting treatment because of the risk of HBV reactivation.

Mechanism of action: how sofosbuvir works

Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase. Further mechanistic detail (intracellular metabolism, incorporation into viral RNA, chain termination) was not established in the sources reviewed for this page. (1)

What sofosbuvir is used for

Chronic hepatitis C virus infection

Sofosbuvir is indicated as a component of a combination antiviral treatment regimen for chronic HCV infection in adults with genotypes 1-4 and in pediatric patients 3 years and older with genotypes 2-3. It is not used as monotherapy. Exact regimen components and treatment duration depend on genotype, prior treatment history, and local product information. (1)

Before taking sofosbuvir

Do not take / not appropriate for

Do not start sofosbuvir-containing treatment without first being tested for current or prior hepatitis B virus (HBV) infection. HBV reactivation can occur during or after HCV direct-acting antiviral treatment and has caused serious liver problems and death. (all products) (1)
When sofosbuvir is combined with ribavirin or peginterferon alfa plus ribavirin, all contraindications that apply to those medicines also apply to the combination. In particular, ribavirin-containing regimens are contraindicated in pregnancy. Whether this extends to male partners of pregnant women was not established in the sources reviewed for this page. (combination regimens only) (1)

Tell your clinician about

Any history of hepatitis B infection, liver disease other than HCV, or previous HCV treatment and outcome.
All current medicines, especially amiodarone (a heart-rhythm medicine), rifampin, St. John's wort, or any other prescription, over-the-counter, or herbal product.
Pregnancy, plans for pregnancy, or breastfeeding status — particularly important if the prescribed regimen includes ribavirin.
Kidney function problems, including whether you receive dialysis.

(1)

How to take sofosbuvir

Sofosbuvir is taken as one 400 mg tablet once daily with or without food.
It must be taken together with other HCV antiviral medicines as prescribed; the exact combination and treatment duration (ranging from 12 to 24 weeks depending on genotype and treatment history) are set by the prescriber.
Do not alter the dose, stop treatment early, or skip doses without the prescriber's explicit instruction.

(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)

Missed dose

Contact the prescriber for instructions if a dose is missed.

Overdose

If an overdose is suspected, contact a poison-information service or seek emergency care.

Side effects

The adverse-reaction profile depends on the specific combination regimen used. The most common adverse reactions are listed below for the main combination categories in the US label.

Fatigue and headache

What to notice: Unusual tiredness, lack of energy, or headache. These were the most common adverse reactions when sofosbuvir was used with ribavirin.

What to do: Tell the prescriber if these symptoms are severe, persistent, or interfere with daily activities. (1)

Fatigue, headache, nausea, insomnia, anemia

What to notice: These were the most common adverse reactions when sofosbuvir was used with peginterferon alfa plus ribavirin. Specific anemia symptoms were not established in the sources reviewed for this page.

What to do: Report these symptoms to the prescriber. Whether treatment adjustment is needed is a decision for the prescriber. (1)

Serious symptomatic bradycardia

What to notice: A detailed symptom checklist was not established in the sources reviewed for this page. This risk is specifically linked to coadministration of amiodarone with a sofosbuvir-containing regimen.

What to do: Seek prompt medical attention, particularly if you are taking amiodarone. (1)

Possible hepatitis B reactivation

What to notice: A detailed symptom checklist was not established in the sources reviewed for this page.

What to do: Contact the prescriber promptly for assessment. HBV reactivation can be serious and requires urgent evaluation. (1)

Serious warnings

Hepatitis B virus reactivation — boxed-warning

Symptoms: Fulminant hepatitis, hepatic failure, and death have occurred. A detailed early-symptom checklist was not established in the sources reviewed for this page.

Action: All patients must be tested for HBV before starting sofosbuvir. Seek medical attention promptly for any new or unusual symptom; let the clinician you see advise on whether to continue or stop the sofosbuvir-containing regimen. (1)

Interactions

Medicine or test	Effect	Action
Amiodarone	Coadministration with sofosbuvir-containing regimens may result in serious symptomatic bradycardia.	Coadministration is not recommended. Tell your prescriber if you take amiodarone so they can review your regimen — any decision about cardiac monitoring or alternative treatment is theirs to make. (1)
P-glycoprotein inducers (e.g., rifampin, St. John’s wort)	May significantly decrease sofosbuvir plasma concentrations and reduce its therapeutic effect.	Concurrent use should be avoided. Tell the prescriber and pharmacist about all supplements and herbal products. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Children and adolescents

Sofosbuvir is approved for pediatric patients 3 years and older with HCV genotypes 2-3 as part of a combination regimen. Specific dosing, formulation, and weight-band details were not extracted in this pass; a specialist must use the exact local pediatric prescribing information. (1)

Pregnancy and breastfeeding

Sofosbuvir-containing regimens that include ribavirin are contraindicated in pregnancy. The specific reason was not established in the sources reviewed for this page. No adequate human data exist for sofosbuvir alone in pregnancy. Breastfeeding safety data was not extracted in this pass. Discuss pregnancy plans, pregnancy status, and breastfeeding with the specialist before and during treatment. (1)

People with renal impairment

No dose adjustment is needed for mild-to-moderate renal impairment. No dosage recommendation can be given for severe renal impairment or end-stage renal disease because of the risk of accumulation of a sofosbuvir metabolite. (1)

Monitoring

Before starting

Test all patients for current or prior hepatitis B virus infection.
Confirm the exact HCV genotype, treatment history, and the chosen combination regimen with the prescriber.
Review all concurrent medicines, including amiodarone, rifampin, and St. John's wort.
A specific pre-treatment protocol for renal assessment or pregnancy testing/contraceptive counselling was not established in the sources reviewed for this page; follow the prescriber's guidance for the specific regimen used.

During treatment

Watch for and promptly report any new or unusual symptom, particularly anything that could suggest HBV reactivation or a cardiac effect if taking amiodarone.
A specific monitoring schedule for HBV reactivation, cardiac status, or combination-partner effects (e.g., ribavirin-associated anemia) was not established in the sources reviewed for this page; follow the prescriber's guidance.

(1)

Storage

Follow the storage instructions on the specific product packaging.

Professional information

Clinician-facing context only. Use the current local indication, regimen-specific dosing tables, and full prescribing information for the chosen combination partners.

United States (FDA label, 2026)

Indication: Chronic HCV, adults genotypes 1-4; pediatrics 3 years and older genotypes 2-3

Dose summary: Sofosbuvir 400 mg once daily with or without food, in combination with other HCV antivirals. Treatment duration ranges from 12 to 24 weeks depending on genotype, prior treatment history, and the specific combination regimen used.

Renal context: No dose adjustment for mild-to-moderate renal impairment. No dosage recommendation for severe renal impairment or end-stage renal disease due to metabolite accumulation risk. (1)

Mechanism of action

Hepatic guidance

Use local product information and specialist judgement.

Frequently asked questions

Can I take sofosbuvir alone to treat hepatitis C?

No. Sofosbuvir is approved only as a component of a combination antiviral regimen. It is not used as monotherapy. Your prescriber will choose the specific combination of medicines. (1)

Why do I need a hepatitis B test before starting sofosbuvir?

Hepatitis B virus reactivation can occur in patients who have current or past HBV infection when they receive HCV direct-acting antiviral treatment. This can cause serious liver problems, including fulminant hepatitis, hepatic failure, and death. Testing before starting sofosbuvir is required for all patients. (1)

Can I take sofosbuvir if I am taking amiodarone for my heart?

Coadministration is not recommended because it may cause serious symptomatic bradycardia (an abnormally slow heart rate). Tell your prescriber if you take amiodarone — they will decide how to manage this, which may include reviewing your HCV or heart-rhythm treatment options. (1)

What is the mechanism of action of sofosbuvir?

What is the generic name of Sofosbuvir?

The generic name is sofosbuvir. It is sold under brand names including SOVALDI. (1)

What class of drug is sofosbuvir?

Sofosbuvir is classed as: Nucleotide analog inhibitor of hepatitis C virus (HCV) NS5B polymerase. (1)

References

SOVALDI (sofosbuvir) — prescribing informationU.S. Food and Drug Administration (DailyMed) · United States · accessed 2026-08-05 · source 1
EPCLUSA ACCESS (VELPATASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
Sofosbuvir — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
Vosevi — FDA approval record (Drugs@FDA NDA209195)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
sofosbuvir — RxNorm normalized drug concept (RXCUI 1484911)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5

Brand names by country

Single-ingredient sofosbuvir names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

Sovaldi400 mg, 150 mg, 200 mg · gilead sciences, inc.

Canada

SOVALDI

View brands in additional countries.