Ledipasvir and Sofosbuvir
Ledipasvir and sofosbuvir is a two-drug combination antiviral pill used to treat chronic hepatitis C virus (HCV) infection in adults and children 3 years and older, with or without ribavirin depending on the situation.
🧬 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 2 clinical label sets 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 →
Ledipasvir and sofosbuvir (Harvoni) is a once-daily treatment for chronic hepatitis C that pairs two antivirals, ledipasvir (blocks the viral protein NS5A) and sofosbuvir (blocks NS5B, the enzyme the virus uses to copy itself); available generically and on the market since about 2014, it cures most people who finish the course, though newer combinations are often chosen first. Most people tolerate it easily, and tiredness and headache are the side effects people notice most. The boxed warning is hepatitis B reactivation, so expect a hepatitis B blood test before starting, since a current or past infection can flare during or after treatment and has caused liver failure and death.
Clinical pearls
- Avoid amiodarone, a heart rhythm drug, with this medicine, because together they can slow the heart dangerously, even to cardiac arrest.
- Keep antacids 4 hours apart from your dose; acid reducers like omeprazole or famotidine are allowed only within certain dose limits.
- St. John's wort, rifampin and seizure drugs like carbamazepine or phenytoin lower its levels and can make it work less well.
- If you take diabetes medicine, watch for low blood sugar, since sugar control can improve as the hepatitis C clears.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
If you have both hepatitis C and hepatitis B, treatment for hepatitis C can cause hepatitis B to become active again, sometimes causing severe liver failure or death.
This has happened to people who were not taking hepatitis B medicine, including some who had a past hepatitis B infection that seemed resolved. Everyone should be tested for hepatitis B before starting. If you have signs of hepatitis B infection, your doctor should monitor you during and after treatment and treat hepatitis B if needed. Tell your doctor right away about worsening liver symptoms.
Patient information guide A plain-language walkthrough of Ledipasvir and Sofosbuvir, written from its FDA label.
What Ledipasvir and Sofosbuvir is used for
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Ledipasvir and sofosbuvir treats chronic hepatitis C virus (HCV) infection in adults and children 3 years and older. Harvoni and ledipasvir and sofosbuvir tablets share these approved uses:
- Genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
- Genotype 1 infection with decompensated cirrhosis, together with ribavirin
- Genotype 1 or 4 infection in liver transplant recipients without cirrhosis or with compensated cirrhosis, together with ribavirin
How Ledipasvir and Sofosbuvir works
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This is a fixed-dose combination of two direct-acting antivirals. Ledipasvir blocks a viral protein called NS5A. Sofosbuvir blocks the NS5B polymerase, an enzyme the virus uses to copy its genetic material.
Together they stop the hepatitis C virus from multiplying.
Ledipasvir and Sofosbuvir dosage
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Adults take one tablet by mouth once a day, with or without food. Treatment length depends on genotype, cirrhosis status, and prior treatment. Children 3 years and older are dosed by weight.
- Harvoni is also available as oral pellets with their own Instructions for Use.
- Some people also take ribavirin, which has its own dosing.
- Follow your prescriber's directions and the label for what to do about missed doses.
Dosing details from the FDA-approved label
From the Ledipasvir and 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.
- Genotype 1: Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A)
- HARVONI 12 weeks
- HARVONI for 8 weeks can be considered in treatment-naïve genotype 1 patients without cirrhosis who have pretreatment HCV RNA less than 6 million IU/mL
- One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food in adults
- Genotype 1: Treatment-experienced without cirrhosis
- HARVONI 12 weeks
- Treatment-experienced subjects have failed a peginterferon alfa +/- ribavirin based regimen with or without an HCV protease inhibitor
- Genotype 1: Treatment-experienced with compensated cirrhosis (Child-Pugh A)
- HARVONI 24 weeks
- HARVONI + ribavirin for 12 weeks can be considered in patients eligible for ribavirin
- Genotype 1: Treatment-naïve and treatment-experienced with decompensated cirrhosis (Child-Pugh B or C)
- HARVONI + ribavirin 12 weeks
- See Dosage and Administration 2.3 and 2.4 for ribavirin dosage recommendations
- Genotype 1 or 4: Treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A)
- HARVONI + ribavirin 12 weeks
- Genotype 4, 5, or 6: Treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)
- HARVONI 12 weeks
- Pediatric patients 3 years of age and older
- Dosage is based on weight
- Refer to Table 2 of the full prescribing information
- Follow Instructions for Use for preparation and administration of oral pellets
- Patients with any degree of renal impairment, including end stage renal disease on dialysis
- No HARVONI dosage adjustment is recommended
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 treatment regimen and duration in patients 3 years of age and older: ( 2.2 ) HCV Genotype Patient Population Regimen and Duration Genotype 1 Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A) Ledipasvir and sofosbuvir 12 weeks Treatment-experienced without cirrhosis Ledipasvir and sofosbuvir 12 weeks Treatment-experienced with compensated cirrhosis (Child-Pugh A) Ledipasvir and sofosbuvir 24 weeks Treatment-naïve and treatment-experienced with decompensated cirrhosis (Child-Pugh B or C) Ledipasvir and sofosbuvir + ribavirin 12 weeks Genotype 1 or 4 Treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A) Ledipasvir and sofosbuvir + ribavirin 12 weeks Genotype 4, 5, or 6 Treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A) Ledipasvir and sofosbuvir 12 weeks Recommended dosage in adults: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food. ( 2.3 ) Recommended dosage in pediatric patients 3 years and older: Recommended dosage of ledipasvir and sofosbuvir in pediatric patients 3 years of age and older is based on weight. Refer to Table 2 of the full prescribing information for specific dosing guidelines based on body weight. ( 2.4 ) Instructions for Use should be followed for preparation and administration of ledipasvir and sofosbuvir (HARVONI) oral pellets. ( 2.5 ) HCV/HIV-1 coinfection: For adult and pediatric patients with HCV/HIV-1 coinfection, follow the dosage recommendations in the tables in the full prescribing information. ( 2.3 , 2.4 ) If used in combination with ribavirin, follow the recommendations for ribavirin dosing and dosage modifications. ( 2.3 , 2.4 ) For patients with any degree of renal impairment, including end stage renal disease on dialysis, no ledipasvir and sofosbuvir dosage adjustment is recommended.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Ledipasvir and Sofosbuvir side effects
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The most common side effects in clinical trials were:
Common side effects
- Fatigue
- Headache
- Weakness (asthenia)
- Nausea
- Diarrhea
- Trouble sleeping (insomnia)
When to get medical help
- Get medical help right away if you feel near-fainting, faint, dizzy, lightheaded, very weak or tired, short of breath, have chest pain, or feel confused. These can be signs of a dangerously slow heart rate, especially if you take amiodarone.
- Call your doctor if you have signs of a hepatitis B flare, such as new or worsening liver problems, during or after treatment.
- If you have diabetes, tell your doctor about symptoms of low blood sugar. Blood sugar control can change as hepatitis C clears.
- If you take ribavirin too, follow its warnings, including avoiding pregnancy.
Serious reactions include a dangerously slow heart rate with amiodarone and hepatitis B reactivation. Seek medical care promptly for fainting, dizziness, chest pain, shortness of breath, confusion, or worsening liver symptoms.
Ledipasvir and Sofosbuvir warnings and precautions
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- Hepatitis B reactivation: can cause liver failure and death in people with both hepatitis B and C. Testing before treatment and monitoring are needed.
- Amiodarone: can cause serious slow heart rate, usually within hours to days but up to 2 weeks after starting. Risk is higher with beta blockers, heart conditions, or advanced liver disease.
- P-gp inducers: rifampin and St. John's wort can reduce how well the medicine works.
- Ribavirin: if combined, its warnings and contraindications apply, especially avoiding pregnancy.
Ledipasvir and Sofosbuvir interactions
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Several medicines can change how this drug works or be affected by it.
- Amiodarone: risk of serious slow heart rate
- Rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, St. John's wort: lower drug levels
- Rosuvastatin: higher levels and muscle damage risk; not recommended
- Atorvastatin: monitor for muscle problems
- Digoxin: levels may rise
- Antacids: separate by 4 hours
- Tenofovir-containing HIV regimens: tenofovir levels may rise
- Warfarin and diabetes medicines: may need monitoring as liver function changes
Interactions listed in the FDA-approved label
From the Ledipasvir and Sofosbuvir prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Amiodarone: Coadministration may result in serious symptomatic bradycardia; the mechanism is unknown. Not recommended; if coadministration is required, cardiac monitoring is recommended.
- P-gp inducers (e.g., rifampin, St. John's wort): May decrease ledipasvir and sofosbuvir plasma concentrations, leading to reduced therapeutic effect. Use is not recommended.
- Carbamazepine, phenytoin, phenobarbital: Expected to decrease the concentration of ledipasvir and sofosbuvir, leading to reduced therapeutic effect. Coadministration is not recommended.
- Antacids (e.g., aluminum and magnesium hydroxide): Drugs that increase gastric pH are expected to decrease ledipasvir concentration. Separate antacid and ledipasvir and sofosbuvir administration by 4 hours.
- Digoxin: May increase the concentration of digoxin. Therapeutic concentration monitoring of digoxin is recommended.
- Rosuvastatin: May significantly increase rosuvastatin concentration, associated with increased risk of myopathy, including rhabdomyolysis. Coadministration is not recommended.
- Atorvastatin: May be associated with increased risk of myopathy, including rhabdomyolysis. Monitor closely for HMG-CoA reductase inhibitor-associated adverse reactions, such as myopathy and rhabdomyolysis.
- Simeprevir: Concentrations of ledipasvir and simeprevir are increased. Coadministration is not recommended.
- Regimens containing tenofovir DF without an HIV protease inhibitor/ritonavir or cobicistat: Increases tenofovir concentration. Monitor for tenofovir-associated adverse reactions; refer to Viread or Truvada prescribing information for renal monitoring.
- Abacavir, atazanavir/ritonavir, cyclosporine, darunavir/ritonavir, dolutegravir, efavirenz, methadone, tacrolimus, verapamil and others listed: No clinically significant drug interactions have been observed or are expected.
Read the label’s full interactions text
7 DRUG INTERACTIONS Coadministration with amiodarone may result in serious symptomatic bradycardia. Use of ledipasvir and sofosbuvir with amiodarone is not recommended. ( 5.2 , 6.2 , 7.2 ) P-gp inducers (e.g., rifampin, St. John's wort): May alter concentrations of ledipasvir and sofosbuvir. Use of ledipasvir and sofosbuvir with P-gp inducers is not recommended. ( 5.3 , 7 , 12.3 ) Consult the full prescribing information prior to use for potential 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. ( 7.2 ) 7.1 Potential for Drug Interaction Any interactions that have been identified with ledipasvir or sofosbuvir individually may occur with ledipasvir and sofosbuvir. After oral administration of ledipasvir and sofosbuvir, sofosbuvir is rapidly absorbed and subject to extensive first-pass hepatic extraction. In clinical pharmacology studies, both sofosbuvir and the inactive metabolite GS-331007 were monitored for purposes of pharmacokinetic analyses. Ledipasvir is an inhibitor of the drug transporters P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of coadministered substrates for these transporters. Ledipasvir and sofosbuvir are substrates of drug transporters P-gp and BCRP while GS-331007 is not. P-gp inducers (e.g., rifampin, St. John's wort) may decrease ledipasvir and sofosbuvir plasma concentrations, leading to reduced therapeutic effect of ledipasvir and sofosbuvir, and the use with P-gp inducers is not recommended with ledipasvir and sofosbuvir [see Warnings and Precautions (5.3) ] .
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 Ledipasvir and Sofosbuvir
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- Get tested for hepatitis B first.
- Tell your doctor about heart problems, advanced liver disease, or use of amiodarone or beta blockers.
- With ribavirin, pregnancy must be avoided, including by men whose partners are pregnant.
- Human pregnancy data are inadequate; discuss with your doctor.
- Breast milk transfer is unknown.
- Not established in children under 3.
- Older adults: no dose change needed.
- Kidney or liver impairment: no dose change recommended.
Ledipasvir and Sofosbuvir overdose
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There is no specific antidote. If an overdose happens, you should be monitored for signs of toxicity and given general supportive care, such as checking vital signs. Dialysis is unlikely to remove ledipasvir but can remove the main sofosbuvir metabolite.
What Ledipasvir and Sofosbuvir does in the body
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Thorough QT studies were done for both drugs. At higher-than-recommended doses, neither ledipasvir nor sofosbuvir prolonged the QTc interval, a measure of heart rhythm timing, to any clinically relevant extent.
How your body processes Ledipasvir and Sofosbuvir
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Sofosbuvir is absorbed quickly, peaking in about an hour, while ledipasvir peaks in about 4 to 4.5 hours. Food does not significantly affect response, so it can be taken with or without food. Sofosbuvir is processed in the liver into its active form and an inactive metabolite that the kidneys clear. Ledipasvir is mostly cleared through bile into feces and has a half-life of about 47 hours.
How to store Ledipasvir and 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 Ledipasvir and Sofosbuvir
55 supplements and herbal products have documented interactions with Ledipasvir and 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.
Ledipasvir and Sofosbuvir: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Ledipasvir and Sofosbuvir — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine 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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Are there medicines or supplements I should avoid?
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Is it safe in pregnancy?
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Is Ledipasvir and Sofosbuvir available over the counter?
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When was Ledipasvir and Sofosbuvir first available?
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Who makes Ledipasvir and Sofosbuvir?
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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 Ledipasvir and Sofosbuvir on HelloPharmacist
Ledipasvir and Sofosbuvir forms and strengths (how it comes)
Ledipasvir and 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.
Tablet
How this form is used
- Harvoni and ledipasvir and sofosbuvir tablets are used to treat chronic hepatitis C virus infection in adults and children 3 years and older.
- For adults, Harvoni is one tablet by mouth once daily with or without food.
- Ledipasvir and sofosbuvir tablets can be taken without regard to food.
Other oral form
How this form is used
- Harvoni is used to treat chronic hepatitis C virus infection in adults and children 3 years and older, as listed on its label.
- Harvoni oral pellets come with Instructions for Use for preparation and administration.
- Harvoni dosing in children 3 years and older is based on weight.
Ledipasvir and Sofosbuvir on the U.S. market: products, makers and brands
How Ledipasvir and 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.
2 companies list 5 Ledipasvir and Sofosbuvir product records with the FDA, mostly as tablet, other oral form; the earliest marketing or approval year on record is 2014. Brand names on the directory include Harvoni; 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Ledipasvir and Sofosbuvir is used (Medicaid data)
A general measure of how commonly Ledipasvir and Sofosbuvir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ledipasvir and Sofosbuvir is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ledipasvir and Sofosbuvir prescribed? Of the 1,601 medications we measure, Ledipasvir and Sofosbuvir ranks #1,509 by Medicaid prescriptions — more than 6% of them.
Utilization by Ledipasvir and Sofosbuvir product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
ledipasvir 90 MG / sofosbuvir 400 MG Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1591943
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ledipasvir and Sofosbuvir, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Ledipasvir and Sofosbuvir NDCs with Medicaid activity.
Compare Ledipasvir and Sofosbuvir products
A representative set of FDA-listed product records for Ledipasvir and 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 | ||||
| LEDIPASVIR 33.75 mg/1; SOFOSBUVIR 150 mg | Oral | Gilead Sciences, Inc | NDA | View NDC → |
| LEDIPASVIR 45 mg/1; SOFOSBUVIR 200 mg | Oral | Gilead Sciences, Inc | NDA | View NDC → |
| 💊Tablet | ||||
| LEDIPASVIR 90 mg/1; SOFOSBUVIR 400 mg | Oral | Asegua Therapeutics LLC | NDA AUTHORIZED GENERIC | View NDC → |
| LEDIPASVIR 45 mg/1; SOFOSBUVIR 200 mg | Oral | Gilead Sciences, Inc | NDA | View NDC → |
| LEDIPASVIR 90 mg/1; SOFOSBUVIR 400 mg | Oral | Gilead Sciences, Inc | NDA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Ledipasvir and Sofosbuvir NDCs →
Ledipasvir and 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 Ledipasvir and 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 Ledipasvir and 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.
Ledipasvir and Sofosbuvir FDA approval history
How Ledipasvir and Sofosbuvir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Ledipasvir and 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 Ledipasvir and Sofosbuvir recalls since July 2021.
✅No Ledipasvir and 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 exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 1591942 2 dose forms · 4 strengths
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Dose form (SCDF) Oral Pellet RxCUI 2204094In current FDA listingsClinical drug / strength (SCD) ledipasvir 33.75 MG / sofosbuvir 150 MGRxCUI 2204100ledipasvir 45 MG / sofosbuvir 200 MGRxCUI 2204103 -
Dose form (SCDF) Oral Tablet RxCUI 1591941In current FDA listingsClinical drug / strength (SCD) ledipasvir 45 MG / sofosbuvir 200 MGRxCUI 2203895ledipasvir 90 MG / sofosbuvir 400 MGRxCUI 1591943
Look up RxCUI 1591942 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.
Ledipasvir and Sofosbuvir supply and shortage status
Whether Ledipasvir and 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.
Ledipasvir and Sofosbuvir brand names
Ledipasvir and Sofosbuvir is sold under one brand name in the FDA directory — Harvoni. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Ledipasvir and Sofosbuvir: manufacturers and labelers
2 companies list Ledipasvir and Sofosbuvir products with the FDA. By number of product records, the largest are Gilead Sciences, Inc, Asegua Therapeutics LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Ledipasvir and Sofosbuvir drug class (RxNorm)
Ledipasvir and 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 Ledipasvir and 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 →