Sofosbuvir
Sofosbuvir is an antiviral medicine used in combination with other drugs to treat chronic hepatitis C virus (HCV) infection in adults and in children 3 years and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Sofosbuvir (Sovaldi) is a direct-acting antiviral for chronic hepatitis C in adults and children 3 and older; it blocks an enzyme the virus needs to copy itself, and since reaching the market around 2013 it has become a backbone of hepatitis C treatment, always paired with other antivirals. It is usually well tolerated, with tiredness and headache the most common complaints, while nausea, trouble sleeping and anemia (low red blood cells) show up mainly alongside peginterferon and ribavirin. Its boxed warning concerns hepatitis B reactivation, which has led to liver failure and death, so everyone needs a hepatitis B test before starting.
Clinical pearls
- Amiodarone with sofosbuvir can slow the heart dangerously, so report fainting, dizziness or shortness of breath right away.
- Skip St. John's wort, and tell every prescriber you take it, since rifampin and several seizure medicines can weaken it.
- On warfarin or diabetes medicines, expect closer INR (clotting test) and blood sugar checks as the virus clears.
- Take it once daily with or without food, and finish the full course even after you feel well.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Hepatitis B can flare up or reactivate in people who have both hepatitis C and hepatitis B while being treated for hepatitis C. This has happened during treatment and after it finished, in people not taking hepatitis B medicine.
Some cases led to sudden severe liver inflammation (fulminant hepatitis), liver failure and death. You should be tested for current or past hepatitis B before starting Sovaldi. If you have signs of hepatitis B, your doctor will monitor you during and after treatment and manage the infection as needed.
Patient information guide A plain-language walkthrough of Sofosbuvir, written from its FDA label.
What Sofosbuvir is used for
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Sofosbuvir treats chronic hepatitis C virus (HCV) infection as part of a combination regimen.
- Adults with genotype 1, 2, 3 or 4 chronic HCV, without cirrhosis or with compensated cirrhosis, as part of a combination regimen.
- Sovaldi for genotype 1 or 4 in adults: used with peginterferon alfa and ribavirin.
- Sovaldi for genotype 2 or 3 in adults: used with ribavirin.
- Sovaldi for children 3 years and older with genotype 2 or 3 chronic HCV, without cirrhosis or with compensated cirrhosis: used with ribavirin.
How Sofosbuvir works
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Sofosbuvir is a direct-acting antiviral against hepatitis C. It blocks an enzyme called NS5B polymerase that the virus needs to make copies of itself.
Your liver converts sofosbuvir into an active form that does this work.
Sofosbuvir dosage
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Sovaldi is taken by mouth once a day, with or without food. Adults take a tablet. Children 3 years and older take tablets or oral pellets, dosed by weight.
- It is always combined with ribavirin, or with peginterferon alfa plus ribavirin.
- Length of treatment depends on genotype and your situation, and in some adults with liver cancer awaiting a transplant it can be longer.
- Follow your prescriber's directions and the label. Ask your pharmacist what to do if you miss a dose.
Dosing details from the FDA-approved label
From the Sofosbuvir prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults (general dosage)
- One 400 mg tablet, taken orally, once daily with or without food
- Adults, genotype 1 or 4, treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A)
- SOVALDI + peginterferon alfa + ribavirin 12 weeks
- Adults, genotype 2, treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
- SOVALDI + ribavirin 12 weeks
- Adults, genotype 3, treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
- SOVALDI + ribavirin 24 weeks
- Adults with genotype 1 infection who are interferon ineligible
- SOVALDI in combination with ribavirin for 24 weeks can be considered
- Adults with hepatocellular carcinoma awaiting liver transplantation
- SOVALDI in combination with ribavirin for up to 48 weeks or until liver transplantation, whichever occurs first
- Pediatric patients 3 years of age and older, genotype 2, treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
- SOVALDI + ribavirin 12 weeks
- Tablets or oral pellets dosed by body weight (see Table 3 of the full prescribing information)
- Weight-based dosing
- Pediatric patients 3 years of age and older, genotype 3, treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
- SOVALDI + ribavirin 24 weeks
- Tablets or oral pellets dosed by body weight (see Table 3 of the full prescribing information)
- Weight-based dosing
- Patients with severe renal impairment or end stage renal disease
- A dosage recommendation cannot be made
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc. ( 2.1 ) Recommended dosage in adults: One 400 mg tablet taken once daily with or without food. ( 2.2 ) Recommended dosage in pediatric patients 3 years of age and older: Recommended dosage of SOVALDI in pediatric patients 3 years of age and older with genotype 2 or 3 HCV using SOVALDI tablets or oral pellets is based on weight. Refer to Table 3 of the full prescribing information for specific dosing guidelines based on body weight. ( 2.3 ) HCV/HIV-1 coinfection: For adult and pediatric patients with HCV/HIV-1 coinfection, follow the dosage recommendations in the tables below, respectively. ( 2.2 , 2.3 ) Recommended adult treatment regimen and duration: ( 2.2 ) Adult Patient Population Regimen and Duration Genotype 1 or 4 Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + peginterferon alfa + ribavirin 12 weeks Genotype 2 Treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + ribavirin 12 weeks Genotype 3 Treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + ribavirin 24 weeks SOVALDI in combination with ribavirin for 24 weeks can be considered for adult patients with genotype 1 infection who are interferon ineligible. ( 2.2 ) Should be used in combination with ribavirin for treatment of HCV in adult patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation, whichever occurs first. ( 2.2 ) Recommended treatment regimen and duration for pediatric patients 3 years of age and older: ( 2.3 , 2.4 ) Pediatric Patient Population 3 Years of Age and Older Regimen and Duration Genotype 2 Treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + ribavirin 12 weeks Genotype 3 Treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + ribavirin 24 weeks A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease. ( 2.7 , 8.6 ) Instructions for Use should be followed for preparation and administration of SOVALDI oral pellets.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Sofosbuvir side effects
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Side effects depend partly on the medicines taken with Sovaldi.
Common side effects
- Fatigue
- Headache
- Nausea (when combined with peginterferon alfa and ribavirin)
- Trouble sleeping (insomnia) (when combined with peginterferon alfa and ribavirin)
- Anemia (low red blood cells) (when combined with peginterferon alfa and ribavirin)
- Decreased appetite (in children taking it with ribavirin oral solution)
When to get medical help
- Call your doctor right away if you have yellowing of the skin or eyes, or signs of a hepatitis flare. Hepatitis B can reactivate during or after hepatitis C treatment.
- Get medical help immediately if you have near-fainting or fainting, dizziness, lightheadedness, unusual weakness or tiredness, shortness of breath, chest pain, or confusion or memory problems. These can be signs of a dangerously slow heart rate, especially if you also take amiodarone.
- If you have diabetes, report symptoms of low blood sugar. Clearing hepatitis C can change blood sugar control, and serious low blood sugar has been reported.
- Tell your doctor if your heart rate seems unusually slow, especially if you take amiodarone.
Sofosbuvir warnings and precautions
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- Hepatitis B reactivation: can cause severe liver problems, liver failure and death in people with both hepatitis C and hepatitis B. Testing before treatment and monitoring afterward are needed.
- Slow heart rate with amiodarone: serious cases, some needing a pacemaker, and one fatal cardiac arrest have been reported. It can occur within hours to days, or up to 2 weeks after starting. Risk may be higher with beta blockers, heart conditions or advanced liver disease.
- Reduced effect with certain drugs: rifampin and St. John's wort can lower sofosbuvir levels.
- Combination drugs: warnings for ribavirin and peginterferon alfa also apply.
Sofosbuvir interactions
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Some medicines can make Sovaldi less effective or cause heart problems.
- Amiodarone: risk of serious slow heart rate. Not recommended.
- Rifampin, rifabutin, rifapentine: lower sofosbuvir levels.
- St. John's wort: lowers sofosbuvir levels.
- Carbamazepine, phenytoin, phenobarbital, oxcarbazepine: expected to lower sofosbuvir levels.
- Tipranavir/ritonavir: expected to lower sofosbuvir levels.
- Warfarin and diabetes medicines: curing hepatitis C can change liver function, so INR and blood sugar may need closer monitoring.
Interactions listed in the FDA-approved label
From the Sofosbuvir prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Amiodarone: Coadministration with a sofosbuvir-containing regimen may result in serious symptomatic bradycardia; the mechanism is unknown. Coadministration is not recommended; if required, cardiac monitoring is recommended.
- Anticonvulsants: carbamazepine, phenytoin, phenobarbital, oxcarbazepine: Expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Coadministration is not recommended.
- Antimycobacterials: rifabutin, rifampin, rifapentine: Expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Coadministration is not recommended.
- St. John's wort (Hypericum perforatum): An intestinal P-gp inducer that may decrease sofosbuvir concentration (↓ sofosbuvir, ↓ GS-331007). Coadministration is not recommended.
- Tipranavir/ritonavir: Expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Coadministration is not recommended.
- Diabetes medications: Clearance of HCV infection may alter blood glucose control, with serious symptomatic hypoglycemia reported in diabetic patients. Monitor blood glucose frequently; dose adjustments of concomitant medications may be necessary.
- Warfarin: Clearance of HCV infection may change hepatic function and affect safe use of concomitant medications. Frequent monitoring of INR is recommended; dose adjustments may be necessary.
- Cytochrome P450 substrates with a narrow therapeutic index (e.g. certain immunosuppressants): Changes in hepatic function after HCV clearance may affect safe and effective use. Frequent monitoring of drug concentrations is recommended; dose adjustments may be necessary.
- Cyclosporine, darunavir/ritonavir, efavirenz, emtricitabine, methadone, oral contraceptives, raltegravir, rilpivirine, tacrolimus, tenofovir disoproxil fumarate: No clinically significant drug interactions have been observed or are expected.
Read the label’s full interactions text
7 DRUG INTERACTIONS Coadministration of amiodarone with a sofosbuvir-containing regimen may result in serious symptomatic bradycardia. ( 5.2 , 6.2 , 7.1 ) Drugs that are intestinal P-gp inducers (e.g., rifampin, St. John's wort) may alter the concentrations of sofosbuvir. ( 5.3 , 7 , 12.3 ) Consult the full prescribing information prior to use for potential drug-drug interactions. ( 5.2 , 5.3 , 7 , 12.3 ) Clearance of HCV infection with direct acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary. ( 7.1 ) 7.1 Potentially Significant Drug Interactions Sofosbuvir is a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP) while the predominant circulating metabolite GS-331007 is not. Drugs that are P-gp inducers in the intestine (e.g., rifampin or St. John's wort) may decrease sofosbuvir plasma concentration, leading to reduced therapeutic effect of SOVALDI, and thus concomitant use with SOVALDI is not recommended [see Warnings and Precautions (5.3) ] . Clearance of HCV infection with direct acting antivirals may lead to changes in hepatic function, which may impact the safe and effective use of concomitant medications. For example, altered blood glucose control resulting in serious symptomatic hypoglycemia has been reported in diabetic patients in postmarketing case reports and published epidemiological studies. Management of hypoglycemia in these cases required either discontinuation or dose modification of concomitant medications used for diabetes treatment. Frequent monitoring of relevant laboratory parameters (e.g.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Sofosbuvir
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- Get tested for hepatitis B before starting.
- Pregnancy: with ribavirin or peginterferon alfa plus ribavirin, the combination is contraindicated in pregnant women and in men whose female partners are pregnant.
- Breastfeeding: it is not known whether sofosbuvir enters human milk. Discuss with your doctor.
- Children: studied in those 3 years and older with genotype 2 or 3. Not established under 3 years or with genotype 1 or 4.
- Older adults: no dose adjustment needed.
- Kidney: no adjustment for mild or moderate impairment. No recommendation for severe impairment or end-stage kidney disease.
- Liver: no adjustment for mild, moderate or severe impairment, but not established in decompensated cirrhosis or after liver transplant.
Sofosbuvir overdose
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The highest dose studied was three times the recommended dose in healthy volunteers, with no unexpected effects. There is no specific antidote. If an overdose occurs, you should be monitored for signs of toxicity and given general supportive care. Hemodialysis removed about 18% of a dose in a 4-hour session.
What Sofosbuvir does in the body
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Sofosbuvir is a direct-acting antiviral against hepatitis C. At three times the recommended dose, it did not lengthen the QTc interval (a heart rhythm measurement) to any clinically relevant extent in healthy volunteers.
How your body processes Sofosbuvir
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After a dose by mouth, sofosbuvir peaks in the blood within about 0.5 to 2 hours. Food does not substantially change how it is absorbed. The liver converts it into an active form, and its main circulating breakdown product (GS-331007) is cleared mostly through the kidneys, with most of a dose recovered in urine. Sofosbuvir's half-life is about 0.4 hours, while GS-331007's is about 27 hours. In children 3 years and older, drug levels were similar to those in adults.
How to store Sofosbuvir
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Store below 30 °C (86 °F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Sofosbuvir
55 supplements and herbal products have documented interactions with Sofosbuvir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 37
- Minor · 16
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Sofosbuvir: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Sofosbuvir — the kind of thing our pharmacy team would talk through with you at the counter.
What is Sofosbuvir used for?
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How do I take it?
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What side effects should I expect?
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Why do I need a hepatitis B test first?
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What medicines should I avoid?
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Is it safe in pregnancy?
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Is Sofosbuvir available over the counter?
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When was Sofosbuvir first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Sofosbuvir on HelloPharmacist
Sofosbuvir forms and strengths (how it comes)
Sofosbuvir is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Sofosbuvir inactive ingredients by manufacturer.
Tablet
How this form is used
- Sovaldi tablets are used in combination regimens for chronic HCV infection in adults.
- Sovaldi tablets are used in children 3 years and older with genotype 2 or 3 HCV, together with ribavirin.
- Sovaldi tablets are taken by mouth once daily, with or without food.
- In children 3 years and older, Sovaldi tablet dosing is based on body weight.
Other oral form
How this form is used
- Sovaldi oral pellets are used in children 3 years and older with genotype 2 or 3 HCV, together with ribavirin.
- Sovaldi oral pellets are dosed by body weight in children 3 years and older.
- For Sovaldi oral pellets, follow the Instructions for Use for preparation and administration.
Sofosbuvir on the U.S. market: products, makers and brands
How Sofosbuvir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 4 Sofosbuvir product records with the FDA, mostly as tablet, other oral form; the earliest marketing or approval year on record is 2013. Brand names on the directory include Sovaldi; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Sofosbuvir products
A representative set of FDA-listed product records for Sofosbuvir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Other oral form | ||||
| 150 mg | Oral | Gilead Sciences, Inc. | NDA | View NDC → |
| 200 mg | Oral | Gilead Sciences, Inc. | NDA | View NDC → |
| 💊Tablet | ||||
| 200 mg | Oral | Gilead Sciences, Inc. | NDA | View NDC → |
| 400 mg | Oral | Gilead Sciences, Inc. | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Sofosbuvir NDCs →
Sofosbuvir side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sofosbuvir — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sofosbuvir in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Sofosbuvir FDA approval history
How Sofosbuvir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Sofosbuvir recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Sofosbuvir recalls since July 2021.
✅No Sofosbuvir recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1484911 2 dose forms · 4 strengths
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Dose form (SCDF) Oral Pellet RxCUI 2203992In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 1484915In current FDA listings
Look up RxCUI 1484911 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Sofosbuvir supply and shortage status
Whether Sofosbuvir is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Sofosbuvir brand names
Sofosbuvir is sold under one brand name in the FDA directory — Sovaldi. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Sofosbuvir: manufacturers and labelers
One company lists Sofosbuvir products with the FDA. By number of product records, the largest are Gilead Sciences, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sofosbuvir drug class (RxNorm)
Sofosbuvir belongs to the Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Sofosbuvir page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Gilead Sciences, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →