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Sovaldi SOFOSBUVIR 400 mg Tablet, Film Coated, 28-count — NDC 61958-1501-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sovaldi SOFOSBUVIR 400 mg Tablet, Film Coated, 28-count — NDC 61958-1501-1 (Billing 61958-1501-01)

by Gilead Sciences, Inc. · 28 TABLET, FILM COATED in 1 BOTTLE

This is a package of 28 tablets of Sovaldi SOFOSBUVIR 400 mg Tablet, Film Coated from Gilead Sciences, Inc., marketed since Dec 2013 and currently FDA-listed. It is this product's only package size.

NDC 61958-1501-01
🏷️ FDA NDC (as labeled) 61958-1501-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 61958-1501-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61958 labeler · 1501 product · 1 package
Package marketed since
Dec 6, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
28 EA per package
Barcode (UPC-A, from the NDC)
3 6195815011 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61958-1501-1
Product NDC 61958-1501
11-digit billing NDC 61958150101
NCPDP billing unit EA — each (per item)
RxCUI 1484916, 1484922, 2203891, 2203893, 2203993, 2203999, 2204090, 2204092
UNII WJ6CA3ZU8B
Application # NDA204671
SPL Set ID 80beab2c-396e-4a37-a4dc-40fdb62859cf
Established class (EPC) Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of action RNA Replicase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-12-06
Route ORAL
Dosage form TABLET, FILM COATED
Substance SOFOSBUVIR

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 12353080000320
GPI class Sovaldi
GCN Seq No 071748
GCN 35708
HICL code 040795
Ingredient (HICL) Sofosbuvir
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5Y
Therapeutic class — specific (HIC3) Hep C Virus,Nucleotide Analog Ns5B Polymerase Inh
AHFS code 08:18.40.16
AHFS class Hcv Polymerase Inhibitor Antivirals
FDB label name SOVALDI 400 MG TABLET
FDB brand name Sovaldi
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 071748
  • GCN: 35708
  • GPI-14 (Medi-Span): 12353080000320
  • HICL (First Databank): 040795
  • AHFS class code: 08:18.40.16
  • RxCUI (RxNorm): 1484916
Why two NDCs? The FDA registers this code as 61958-1501-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 61958-1501-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor class.

Pharmacologic class Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Drug family (ATC) Antivirals for treatment of HCV infections
How it works RNA Replicase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name SOVALDI 400 MG TABLET Ingredient Sofosbuvir
📗 Our plain-language guide HelloPharmacist
  • It treats chronic hepatitis C infection. It is always used with other medicines, such as ribavirin, or peginterferon alfa plus ribavirin, depending on your genotype. Your prescribe...
  • Take Sovaldi by mouth once a day, with or without food. Take it exactly as prescribed along with your other hepatitis C medicines. Children's doses are based on weight, and the ora...
  • The most common are tiredness and headache. If you also take peginterferon alfa and ribavirin, nausea, trouble sleeping and anemia are common too. Call us or your doctor if side ef...
  • In people with both hepatitis B and C, hepatitis B can reactivate during or after hepatitis C treatment. This can cause serious liver damage. Testing lets your doctor watch you clo...
📖 Read our full Sofosbuvir guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $986.29 $27,616.13 / 28 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61958-1501-01 You're viewing this Main listing 28 TABLET, FILM COATED in 1 BOTTLE 2013-12-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sovaldi 400 mgthis 61958-1501-01 Gilead 28 tablets — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
First FDA approval
Dec 2013
📍
2026
Currently FDA-listed
13 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 6, 2013 RLD RS ⏳ ~4.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 7964580 — drug substance (U-1470)
US 8334270 — drug substance (U-1470)
US 8618076 — drug substance (U-1470)
US 8633309 — drug substance (U-1470)
US 9085573 — drug substance (U-1470)
US 8580765 — drug substance (U-1470)
US 8618076 — drug substance (U-1470)
US 8889159 — method of use (U-1470)
US 8633309 — drug substance (U-1470)
US 8580765 — drug substance (U-1470)
US 8334270 — drug substance (U-1470)
US 9284342 — drug substance (U-1470)
US 9085573 — drug substance (U-1470)
US 7964580 — drug substance (U-1470)
US 9549941 — method of use (U-1958)
US 8889159 — method of use (U-1470)
US 9284342 — drug substance (U-1470)
US 8580765*PED — drug product
US 7964580*PED — drug product
US 8334270*PED — drug product
US 8633309*PED — drug product
US 8618076*PED — drug product
US 8889159*PED — drug product
US 9085573*PED — drug product
US 9284342*PED — drug product
US 9549941*PED — drug product
US 8618076*PED — drug product
US 8889159*PED — drug product
US 8633309*PED — drug product
US 8580765*PED — drug product
US 8334270*PED — drug product
US 9284342*PED — drug product
US 9085573*PED — drug product
US 7964580*PED — drug product
Exclusivity ODE*
Exclusivity ODE*
2013 2015 2017 2019 2021 2023 2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (34)
PatentTypeUse codeExpires
US 7964580 ↗ Drug substance U-1470 Mar 26, 2029
US 8334270 ↗ Drug substance U-1470 Mar 21, 2028
US 8618076 ↗ Drug substance U-1470 Dec 11, 2030
US 8633309 ↗ Drug substance U-1470 Mar 26, 2029
US 9085573 ↗ Drug substance U-1470 Mar 21, 2028
US 8580765 ↗ Drug substance U-1470 Mar 21, 2028
US 8618076 ↗ Drug substance U-1470 Dec 11, 2030
US 8889159 ↗ Method of use U-1470 Mar 26, 2029
US 8633309 ↗ Drug substance U-1470 Mar 26, 2029
US 8580765 ↗ Drug substance U-1470 Mar 21, 2028
US 8334270 ↗ Drug substance U-1470 Mar 21, 2028
US 9284342 ↗ Drug substance U-1470 Sep 13, 2030
US 9085573 ↗ Drug substance U-1470 Mar 21, 2028
US 7964580 ↗ Drug substance U-1470 Mar 26, 2029
US 9549941 ↗ Method of use U-1958 Mar 26, 2029
US 8889159 ↗ Method of use U-1470 Mar 26, 2029
US 9284342 ↗ Drug substance U-1470 Sep 13, 2030
US 8580765*PED ↗ Drug product — Sep 21, 2028
US 7964580*PED ↗ Drug product — Sep 26, 2029
US 8334270*PED ↗ Drug product — Sep 21, 2028
US 8633309*PED ↗ Drug product — Sep 26, 2029
US 8618076*PED ↗ Drug product — Jun 11, 2031
US 8889159*PED ↗ Drug product — Sep 26, 2029
US 9085573*PED ↗ Drug product — Sep 21, 2028
US 9284342*PED ↗ Drug product — Mar 13, 2031
US 9549941*PED ↗ Drug product — Sep 26, 2029
US 8618076*PED ↗ Drug product — Jun 11, 2031
US 8889159*PED ↗ Drug product — Sep 26, 2029
US 8633309*PED ↗ Drug product — Sep 26, 2029
US 8580765*PED ↗ Drug product — Sep 21, 2028
US 8334270*PED ↗ Drug product — Sep 21, 2028
US 9284342*PED ↗ Drug product — Mar 13, 2031
US 9085573*PED ↗ Drug product — Sep 21, 2028
US 7964580*PED ↗ Drug product — Sep 26, 2029
FDA exclusivity
CodeWhat it grantsExpires
ODE*Orphan Drug Exclusivity (7-year)Aug 28, 2026
ODE*Orphan Drug Exclusivity (7-year)Aug 28, 2026
Common questions
Is there a generic version of SOVALDI 400 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for SOVALDI 400 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color yellow / Yellow / White
ShapeRound
ImprintGSI;200
Size2 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Sofosbuvir inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGilead Sciences, Inc.
Application holderGILEAD SCIENCES INC
FDA applicationNDA204671 (NDA)
Labeler code61958
First marketedDec 2013
Product typeHuman Prescription Drug
Portfolio42 products on file

More NDCs from Gilead Sciences, Inc. labeler code 61958

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 149 words ▾

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with SOVALDI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death.

Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1) ] . WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See full prescribing information for complete boxed warning.

Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 )

🎯 Indications and Usage 203 words ▾

1 INDICATIONS AND USAGE SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of: Adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen. ( 1 ) Pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. ( 1 ) Adult Patients: SOVALDI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen [see Dosage and Administration (2.2) , and Clinical Studies (14) ]: genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

Pediatric Patients: SOVALDI is indicated for the treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin [see Dosage and Administration (2.3) and Clinical Studies (14.5) ] .

⏱️ Dosage and Administration ~3 min read ▾

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. ( 2.4 )

2.1Testing Prior to the Initiation of Therapy Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with SOVALDI [see Warnings and Precautions (5.1)] .

2.2Recommended Dosage in Adults The recommended dosage of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food [see Clinical Pharmacology (12.3) ] . Administer SOVALDI in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of HCV. The recommended treatment regimen and duration for SOVALDI combination therapy is provided in Table 1.

For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in Table 1. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs. Table 1 Recommended Treatment Regimen and Duration in Adult Patients with Genotype 1, 2, 3, or 4 HCV Patient Population Treatment Regimen and Duration Genotype 1 or 4 Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A) SOVALDI + peginterferon alfa See peginterferon alfa prescribing information for dosage recommendation for patients with genotype 1 or 4 HCV. + ribavirin Dosage of ribavirin is weight-based (<75 kg = 1000 mg and ≥75 kg = 1200 mg).

The daily dosage of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl ≤50 mL/min) require ribavirin dosage reduction; refer to ribavirin tablet prescribing information. 12 weeks Genotype 2 Treatment-naïve and treatment-… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 117 words ▾

3 DOSAGE FORMS AND STRENGTHS SOVALDI is available as tablets or pellets for oral use. Each dosage form is available in two dose strengths. 400 mg Tablets: 400 mg sofosbuvir: yellow, capsule-shaped, film-coated tablet debossed with "GSI" on one side and "7977" on the other side.

200 mg Tablets: 200 mg sofosbuvir: yellow, oval-shaped, film-coated tablet debossed with "GSI" on one side and "200" on the other side. 200 mg Pellets: 200 mg sofosbuvir: white to off-white pellets in unit-dose packets. 150 mg Pellets: 150 mg sofosbuvir: white to off-white pellets in unit-dose packets.

Tablets: 400 mg and 200 mg of sofosbuvir. ( 3 ) Oral Pellets: 200 mg and 150 mg of sofosbuvir. ( 3 )

⛔ Contraindications 66 words ▾

4 CONTRAINDICATIONS When SOVALDI is used in combination with ribavirin or peginterferon alfa/ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications. When used in combination with peginterferon alfa/ribavirin or ribavirin alone, all contraindications to peginterferon alfa and/or ribavirin also apply to SOVALDI combination therapy.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

( 5.1 ) Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone with a sofosbuvir-containing regimen, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with SOVALDI is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.

( 5.2 , 6.2 , 7.1 )

5.1Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti-HBc positive).

HBV reactivation has also been reported in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients. HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur.

Reactivation of HBV replication may be accompanied by hepatitis, i.e., increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur. Test all patients for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before initiating HCV treatment with SOVALDI. In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment with SOVALDI and during post-treatment follow-up.

Initiate appropriate patient management for HBV infection as clinically indicated.

5.2Serious Symptomatic Bradycardia When Coadministered with Amiodarone Postmarketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is coadministered with a sofosbuvir-containing regimen. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir-containing regimen (HARVONI [ledipasvir/sofosbuvir]). Bradycardia has generally occurred within hours to days, but cases have been observed up to 2 weeks after initiating HCV treatment.

Patients also taking beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with coadministration of amiodarone. Bradycardia generally resolved after discontinuation of HCV treatment. The mechanism for this effect is unknown.

Coadministration of amiodarone with SOVALDI is not recommended. For patients taking amiodarone who have no other alternative, viable treatment options and who will be coadministered SOVALDI: Counsel patients about the risk of serious symptomatic bradycardia Cardiac monitoring in an in-patient setting for the first 48 hours of coadministration is recommended, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment. Patients who are taking SOVALDI who need to start amiodarone therapy due to no other alternative, viable treatment options should undergo similar cardiac moni… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Serious Symptomatic Bradycardia When Coadministered with Amiodarone [see Warnings and Precautions (5.2) ] . The most common adverse events (incidence greater than or equal to 20%, all grades) observed with SOVALDI in combination with ribavirin were fatigue and headache. The most common adverse events observed with SOVALDI in combination with peginterferon alfa and ribavirin were fatigue, headache, nausea, insomnia and anemia.

( 6.1 ). The most common adverse events observed with SOVALDI in combination with ribavirin oral solution in pediatric patients was decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. When SOVALDI is administered with ribavirin or peginterferon alfa/ribavirin, refer to the respective prescribing information for a description of adverse reactions associated with their use. Adverse Reactions in Adult Subjects The safety assessment of SOVALDI was based on pooled Phase 3 clinical trial data (both controlled and uncontrolled) including: 650 subjects who received SOVALDI + ribavirin (RBV) combination therapy for 12 weeks, 98 subjects who received SOVALDI + ribavirin combination therapy for 16 weeks, 250 subjects who received SOVALDI + ribavirin combination therapy for 24 weeks, 327 subjects who received SOVALDI + peginterferon (Peg-IFN) alfa + ribavirin combination therapy for 12 weeks, 243 subjects who received peginterferon alfa + ribavirin for 24 weeks, and 71 subjects who received placebo (PBO) for 12 weeks [see Clinical Studies (14) ] .

The proportion of subjects who permanently discontinued treatment due to adverse events was 4% for subjects receiving placebo, 1% for subjects receiving SOVALDI + ribavirin for 12 weeks, less than 1% for subjects receiving SOVALDI + ribavirin for 24 weeks, 11% for subjects receiving peginterferon alfa + ribavirin for 24 weeks and 2% for subjects receiving SOVALDI + peginterferon alfa + ribavirin for 12 weeks. Adverse events observed in at least 15% of subjects in the Phase 3 clinical trials outlined above are provided in Table 5.

A side-by-side tabulation is displayed to simplify presentation; direct comparison across trials should not be made due to differing trial designs. The most common adverse events (at least 20%) for SOVALDI + ribavirin combination therapy were fatigue and headache. The most common adverse events (at least 20%) for SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia and anemia.

Table 5 Adverse Events (All Grades and without Regard to Causality) Reported in ≥15% of Subjects with HCV in Any Treatment Arm Interferon-free Regimens Interferon-containing Regimens PBO 12 weeks SOVALDI + RBV Subjects received weight-based ribavirin (1000 mg per day if weighing <75 kg or 1200 mg per day if weighing ≥75 kg). 12 weeks SOVALDI + RBV 24 weeks Peg-IFN alfa + RBV Subjects received 800 mg ribavirin per day regardless of weight. 24 weeks SOVALDI + Peg-IFN alfa + RBV 12 weeks N=71 N=650 N=250 N=243 N=327 Fatigue 24% 38% 30% 55% 59% Headache 20% 24% 30% 44% 36% Nausea 18% 22% 13% 29% 34% Insomnia 4% 15% 16% 29% 25% Pruritus 8% 11% 27% 17% 17% Anemia 0% 10% 6% 12% 21% Asthenia 3% 6% 21% 3% 5% Rash 8% 8% 9% 18% 18% Decreased Appetite 10% 6% 6% 18% 18% Chills 1% 2% 2% 18% 17% Influenza Like Illness 3% 3% 6% 18% 16% Pyrexia 0% 4% 4% 14% 18% Diarrhea 6% 9% 12% 17% 12% Neutropenia 0% <1% <1% 12% 17% Myalgia 0% 6% 9% 16% 14% Irritability 1% 10% 10% 16% 13% With the exception of anemia and neutropenia, the majority of… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

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 )

7.1Potentially 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. International Normalized Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic patients) or drug concentrations of concomitant medications such as cytochrome P450 substrates with a narrow therapeutic index (e.g. certain immunosuppressants) is recommended to ensure safe and effective use. Dose adjustments of concomitant medications may be necessary.

Information on potential drug interactions with SOVALDI is summarized in Table 7. The table is not all-inclusive [see Warnings and Precautions (5.2 , 5.3) and Clinical Pharmacology (12.3) ]. Table 7 Potentially Significant Drug Interactions: Alteration in Dosage or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction This table is not all-inclusive.

Concomitant Drug Class: Drug Name Effect on Concentration ↓ = decrease. Clinical Comment Antiarrhythmics: amiodarone Effect on amiodarone and sofosbuvir concentrations unknown Coadministration of amiodarone with a sofosbuvir-containing regimen may result in serious symptomatic bradycardia. The mechanism of this effect is unknown.

Coadministration of amiodarone with SOVALDI is not recommended; if coadministration is required, cardiac monitoring is recommended [see Warnings and Precautions (5.2) , Adverse Reactions (6.2) ]. Anticonvulsants: Carbamazepine phenytoin phenobarbital oxcarbazepine ↓ sofosbuvir ↓ GS-331007 Coadministration of SOVALDI with carbamazepine, phenytoin, phenobarbital or oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Coadministration is not recommended.

Antimycobacterials: Rifabutin rifampin rifapentine ↓ sofosbuvir ↓ GS-331007 Coadministration of SOVALDI with rifabutin or rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Coadministration is not recommended. Coadministration of SOVALDI with rifampin, an intestinal P-gp inducer, is not recommended [see Warnings and Precautions (5.3) ].

Herbal Supplements: St. John's wort (Hypericum perforatum) ↓ sofosbuvir ↓ GS-331007 Coadministration of SOVALDI with St. John's wort, an intestinal P-gp inducer, is not recommended [see Warn… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Patients with HCV/HIV-1 coinfection: Safety and efficacy have been studied. ( 14.4 ) Patients with hepatocellular carcinoma awaiting liver transplantation: Safety and efficacy have been studied. ( 8.8 )

8.1Pregnancy Risk Summary If SOVALDI is administered with ribavirin or peginterferon alfa and ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin and/or peginterferon alfa prescribing information for more information on ribavirin- and peginterferon alfa-associated risks of use during pregnancy. No adequate human data are available to establish whether or not SOVALDI poses a risk to pregnancy outcomes.

In animal reproduction studies, no evidence of adverse developmental outcomes was observed with sofosbuvir at exposures greater than those in humans at the recommended human dose (RHD) [see Data ] . During organogenesis in the rat and rabbit, systemic exposures (AUC) to the predominant circulating metabolite of sofosbuvir (GS-331007) were ≥5 (rats) and 12 (rabbits) times the exposure in humans at the RHD. In the rat pre/postnatal development study, maternal systemic exposure (AUC) to GS-331007 was ≥6 times the exposure in humans at the RHD.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Animal Data Sofosbuvir was administered orally to pregnant rats (up to 500 mg/kg/day) and rabbits (up to 300 mg/kg/day) on gestation days 6 to 18 and 6 to 19, respectively, and also to rats (oral doses up to 500 mg/kg/day) on gestation day 6 to lactation/post-partum day 20.

No significant effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed at the highest doses tested. Systemic exposures (AUC) to the predominant circulating metabolite of sofosbuvir (GS-331007) were ≥5 (rats) and 12 (rabbits) times the exposure in humans at the RHD, with exposures increasing during gestation from approximately 5 to 10 (rats) and 12 to 28 (rabbits) times the exposure in humans at the RHD.

8.2Lactation Risk Summary It is not known whether sofosbuvir or its metabolites are present in human breast milk, affect human milk production or have effects on the breastfed infant. The predominant circulating metabolite of sofosbuvir (GS-331007) was the primary component observed in the milk of lactating rats, without effect on nursing pups [see Data ] . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SOVALDI and any potential adverse effects on the breastfed child from SOVALDI or from the underlying maternal condition.

If SOVALDI is administered with ribavirin, the nursing mother's information for ribavirin also applies to this combination regimen. Refer to the ribavirin prescribing information for more information on use during lactation. Data Animal Data No effects of sofosbuvir on growth and postnatal development were observed in nursing pups at the highest dose tested in rats.

Maternal systemic exposure (AUC) to the predominant circulating metabolite of sofosbuvir (GS-331007) was approximately 12 times the exposure in humans at the RHD, with exposure of approximately 2% that of maternal exposure observed in nursing pups on lactation day 10. In a lactation study, sofosbuvir metabolites (primarily GS-331007) were excreted into the milk of lactating rats following administration of a single oral dose of sofosbuvir (20 mg/kg) on lactation day 2, with milk concentrations of approximately 10% that of maternal plasma concentrations observed 1 hour post-dose.

8.3Females and Males of Reproductive Potential If SOVALDI is administered with ribavirin or peginterferon and ribavirin, the information for ribavirin and peginterferon wit… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary If SOVALDI is administered with ribavirin or peginterferon alfa and ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin and/or peginterferon alfa prescribing information for more information on ribavirin- and peginterferon alfa-associated risks of use during pregnancy. No adequate human data are available to establish whether or not SOVALDI poses a risk to pregnancy outcomes.

In animal reproduction studies, no evidence of adverse developmental outcomes was observed with sofosbuvir at exposures greater than those in humans at the recommended human dose (RHD) [see Data ] . During organogenesis in the rat and rabbit, systemic exposures (AUC) to the predominant circulating metabolite of sofosbuvir (GS-331007) were ≥5 (rats) and 12 (rabbits) times the exposure in humans at the RHD. In the rat pre/postnatal development study, maternal systemic exposure (AUC) to GS-331007 was ≥6 times the exposure in humans at the RHD.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Animal Data Sofosbuvir was administered orally to pregnant rats (up to 500 mg/kg/day) and rabbits (up to 300 mg/kg/day) on gestation days 6 to 18 and 6 to 19, respectively, and also to rats (oral doses up to 500 mg/kg/day) on gestation day 6 to lactation/post-partum day 20.

No significant effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed at the highest doses tested. Systemic exposures (AUC) to the predominant circulating metabolite of sofosbuvir (GS-331007) were ≥5 (rats) and 12 (rabbits) times the exposure in humans at the RHD, with exposures increasing during gestation from approximately 5 to 10 (rats) and 12 to 28 (rabbits) times the exposure in humans at the RHD.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety, pharmacokinetics, and efficacy of SOVALDI in pediatric patients 3 years of age and older with genotype 2 and 3 infection have been established. SOVALDI was evaluated in an open-label clinical trial (Study 1112), which included 106 subjects (31 genotype 2; 75 genotype 3) 3 years of age and older. The safety, pharmacokinetics, and efficacy were comparable to that observed in adults [see Dosage and Administration (2.3) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.5) ] .

The safety and efficacy of SOVALDI in pediatric patients 3 years of age and older with compensated cirrhosis is supported by comparable sofosbuvir and GS-331007 exposures between: 1) adults and pediatric patients without cirrhosis and 2) adults without cirrhosis and adults with compensated cirrhosis. Thus, similar efficacy would be expected for pediatric patients with compensated cirrhosis as adults with compensated cirrhosis. The safety and efficacy of SOVALDI have not been established in pediatric patients less than 3 years of age with HCV genotype 2 or 3.

The safety and efficacy of SOVALDI have not been established in pediatric patients with HCV genotype 1 or 4. In a 5-year follow-up study, the long-term effects of SOVALDI on pediatric growth were assessed in 88 pediatric subjects 3 years of age and older treated with SOVALDI in Study 1112. No notable effects on growth from baseline through end of study were observed [see Adverse Reactions (6.1) ].

All subjects who had achieved SVR12 maintained SVR through end of study.

🧓 Geriatric Use 51 words ▾

8.5Geriatric Use SOVALDI was administered to 90 subjects aged 65 and over. The response rates observed for subjects over 65 years of age were similar to that of younger subjects across treatment groups . No dosage adjustment of SOVALDI is warranted in geriatric patients [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 125 words ▾

10 OVERDOSAGE The highest documented dosage of sofosbuvir was a single dose of sofosbuvir 1200 mg (three times the recommended dosage) administered to 59 healthy subjects. In that trial, there were no untoward effects observed at this dosage level, and adverse events were similar in frequency and severity to those reported in the placebo and sofosbuvir 400 mg treatment groups. The effects of higher dosages are not known.

No specific antidote is available for overdose with SOVALDI. If overdose occurs, the patient must be monitored for evidence of toxicity. Treatment of overdose with SOVALDI consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

A 4-hour hemodialysis session removed 18% of the administered dose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sofosbuvir is a direct-acting antiviral agent against the hepatitis C virus [see Microbiology (12.4) ].

12.2Pharmacodynamics Cardiac Electrophysiology The effect of sofosbuvir 400 and 1200 mg (three times the recommended dosage) on QTc interval was evaluated in a randomized, single-dose, placebo- and active-controlled (moxifloxacin 400 mg) four period crossover thorough QT trial in 59 healthy subjects. At a dosage three times the maximum recommended dosage, SOVALDI does not prolong QTc to any clinically relevant extent.

12.3Pharmacokinetics Absorption The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Following oral administration of SOVALDI, sofosbuvir was absorbed with a peak plasma concentration observed at ~0.5–2 hour post-dose, regardless of dose level. Peak plasma concentration of GS-331007 was observed between 2 to 4 hours post-dose.

Based on population pharmacokinetic analysis in subjects with genotype 1 to 6 HCV infection who were coadministered ribavirin (with or without pegylated interferon), geometric mean steady state AUC 0–24 was 969 ng∙hr/mL for sofosbuvir (N=838), and 6790 ng∙hr/mL for GS-331007 (N=1695). Relative to healthy subjects administered sofosbuvir alone (N=272), the sofosbuvir AUC 0–24 was 60% higher; and GS-331007 AUC 0–24 was 39% lower, respectively, in HCV-infected subjects. Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 1200 mg.

Effect of Food Relative to fasting conditions, the administration of a single dose of SOVALDI with a standardized high fat meal did not substantially affect the sofosbuvir C max or AUC 0–inf . The exposure of GS-331007 was not altered in the presence of a high-fat meal. Therefore, SOVALDI can be administered without regard to food.

Distribution Sofosbuvir is approximately 61–65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 microgram/mL to 20 microgram/mL. Protein binding of GS-331007 was minimal in human plasma. After a single 400 mg dose of [ 14 C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14 C-radioactivity was approximately 0.7.

Metabolism Sofosbuvir is extensively metabolized in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203. The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalyzed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway. Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro .

After a single 400 mg oral dose of [ 14 C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and greater than 90% of drug related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively. Elimination Following a single 400 mg oral dose of [ 14 C]-sofosbuvir, mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, feces, and expired air, respectively. The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.

These data indicate that renal clearance is the major elimination pathway for GS-331007. The median terminal half-lives of sofosbuvir and GS-331007 were 0.4 and 27 hours, respectively. Specific Populations Race Population pharmacokinetics analysis in HCV-infected subjects indicated that race had no clinically relevant effect on the exposure of sofosbuvir and GS-331007.

Gender No clinically relevant pharmacokinetic differences have be… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action Sofosbuvir is a direct-acting antiviral agent against the hepatitis C virus [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling 177 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tablets SOVALDI tablets, 400 mg, are yellow, capsule-shaped, film-coated tablets containing 400 mg sofosbuvir debossed with "GSI" on one side and "7977" on the other side. Each bottle contains 28 tablets (NDC 61958-1501-1), a silica gel desiccant and polyester coil with a child-resistant closure. SOVALDI tablets, 200 mg, are yellow, oval-shaped, film-coated tablets containing 200 mg sofosbuvir debossed with "GSI" on one side and "200" on the other side.

Each bottle contains 28 tablets (NDC 61958-1503-1) and a polyester coil with a child-resistant closure. Store below 30 °C (86 °F). Dispense only in original container Do not use if seal over bottle opening is broken or missing Oral Pellets SOVALDI pellets, 150 mg, are white to off-white pellets supplied as unit-dose packets in cartons.

Each carton contains 28 packets (NDC 61958-1504-1) SOVALDI pellets, 200 mg, are white to off-white pellets supplied as unit-dose packets in cartons. Each carton contains 28 packets (NDC 61958-1505-1) Store below 30 °C (86 °F). Do not use if carton tamper-evident or packet seal is broken or damaged.

📦 Storage and Handling 23 words ▾

Store below 30 °C (86 °F). Dispense only in original container Do not use if seal over bottle opening is broken or missing

📋 Description ~1 min read ▾

11 DESCRIPTION SOVALDI (sofosbuvir) is a nucleotide analog inhibitor of HCV NS5B polymerase. The IUPAC name for sofosbuvir is ( S )-isopropyl 2-(( S )-(((2 R ,3 R ,4 R ,5 R )-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2 H )-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)-(phenoxy)phosphorylamino)propanoate. It has a molecular formula of C 22 H 29 FN 3 O 9 P and a molecular weight of 529.45.

It has the following structural formula: Sofosbuvir is a white to off-white crystalline solid with a solubility of ≥ 2 mg/mL across the pH range of 2–7.7 at 37 °C and is slightly soluble in water. SOVALDI tablets, 200 mg or 400 mg, are for oral administration. Each tablet contains 200 mg or 400 mg of sofosbuvir.

The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, and microcrystalline cellulose. The tablets are film-coated with a coating material containing the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide. SOVALDI pellets, 150 mg or 200 mg, are for oral administration, supplied as white to off-white pellets in unit-dose packets.

Each unit-dose packet contains 150 mg or 200 mg of sofosbuvir. The pellets include the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, stearic acid, and talc. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV Inform patients that HBV reactivation can occur in patients coinfected with HBV during or after treatment of HCV infection. Advise patients to tell their healthcare provider if they have a history of HBV infection [see Warnings and Precautions (5.1) ] .

Serious Symptomatic Bradycardia When Coadministered with Amiodarone Advise patients to seek medical evaluation immediately for symptoms of bradycardia such as near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pain, confusion or memory problems [see Warnings and Precautions (5.2) , Adverse Reactions (6.2) , and Drug Interactions (7.1) ] . Pregnancy Advise patients to avoid pregnancy during combination treatment with SOVALDI and ribavirin or SOVALDI and peginterferon and ribavirin.

Inform patients to notify their health care provider immediately in the event of a pregnancy [see Use in Specific Populations (8.1) ] . Drug Interactions Advise patients that SOVALDI may interact with some drugs; therefore, patients should be advised to report the use of any prescription, non-prescription medication or herbal products to their healthcare provider [see Warnings and Precautions (5.3) and Drug Interactions (7.1) ] . Hepatitis C Virus Transmission Inform patients that the effect of treatment of hepatitis C infection on transmission is not known, and that appropriate precautions to prevent transmission of the hepatitis C virus during treatment or in the event of treatment failure should be taken.

Administration Advise patients to take SOVALDI every day at the regularly scheduled time with or without food. Inform patients that it is important not to miss or skip doses and to take SOVALDI for the duration that is recommended by the physician. For SOVALDI oral pellets, advise patients or caregivers to read and follow the Instructions for Use for preparing the correct dose.

Important Information on Coadministration with Ribavirin or Peginterferon and Ribavirin Advise patients that the recommended regimen for patients with genotype 1 or 4 HCV infection is SOVALDI administered in combination with peginterferon alfa and ribavirin and the recommended regimen for patients with genotype 2 or 3 HCV infection is SOVALDI administered in combination with ribavirin. If peginterferon and/or ribavirin are permanently discontinued, SOVALDI should also be discontinued.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Following oral administration of SOVALDI, sofosbuvir was absorbed with a peak plasma concentration observed at ~0.5–2 hour post-dose, regardless of dose level. Peak plasma concentration of GS-331007 was observed between 2 to 4 hours post-dose.

Based on population pharmacokinetic analysis in subjects with genotype 1 to 6 HCV infection who were coadministered ribavirin (with or without pegylated interferon), geometric mean steady state AUC 0–24 was 969 ng∙hr/mL for sofosbuvir (N=838), and 6790 ng∙hr/mL for GS-331007 (N=1695). Relative to healthy subjects administered sofosbuvir alone (N=272), the sofosbuvir AUC 0–24 was 60% higher; and GS-331007 AUC 0–24 was 39% lower, respectively, in HCV-infected subjects. Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 1200 mg.

Effect of Food Relative to fasting conditions, the administration of a single dose of SOVALDI with a standardized high fat meal did not substantially affect the sofosbuvir C max or AUC 0–inf . The exposure of GS-331007 was not altered in the presence of a high-fat meal. Therefore, SOVALDI can be administered without regard to food.

Distribution Sofosbuvir is approximately 61–65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 microgram/mL to 20 microgram/mL. Protein binding of GS-331007 was minimal in human plasma. After a single 400 mg dose of [ 14 C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14 C-radioactivity was approximately 0.7.

Metabolism Sofosbuvir is extensively metabolized in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203. The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalyzed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway. Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro .

After a single 400 mg oral dose of [ 14 C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and greater than 90% of drug related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively. Elimination Following a single 400 mg oral dose of [ 14 C]-sofosbuvir, mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, feces, and expired air, respectively. The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.

These data indicate that renal clearance is the major elimination pathway for GS-331007. The median terminal half-lives of sofosbuvir and GS-331007 were 0.4 and 27 hours, respectively. Specific Populations Race Population pharmacokinetics analysis in HCV-infected subjects indicated that race had no clinically relevant effect on the exposure of sofosbuvir and GS-331007.

Gender No clinically relevant pharmacokinetic differences have been observed between men and women for sofosbuvir and GS-331007. Pediatric Patients The pharmacokinetics of sofosbuvir and GS-331007 were determined in HCV genotype 2 or 3 infected pediatric subjects 3 years of age and older receiving a daily dose of SOVALDI as described in Table 8. Exposures in pediatric subjects were similar to those observed in adults.

Table 8 Pharmacokinetic Properties of SOVALDI in HCV-infected Pediatric Subjects 3 Years of Age and Older Population PK derived parameters Weight Group Dose PK Parameter Geometric Mean (%CV) Sofosbuvir GS-331007 ≥35 kg S… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 61 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology The effect of sofosbuvir 400 and 1200 mg (three times the recommended dosage) on QTc interval was evaluated in a randomized, single-dose, placebo- and active-controlled (moxifloxacin 400 mg) four period crossover thorough QT trial in 59 healthy subjects. At a dosage three times the maximum recommended dosage, SOVALDI does not prolong QTc to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Description of Clinical Trials The safety and efficacy of SOVALDI was evaluated in five Phase 3 trials in a total of 1724 HCV mono-infected subjects with genotypes 1 to 6 chronic hepatitis C virus, one Phase 3 trial in 223 HCV/HIV-1 coinfected subjects with genotype 1, 2 or 3 HCV, and one trial in 106 pediatric subjects 3 years of age and older with genotype 2 or 3 HCV, as summarized in Table 11 [see Clinical Studies (14.2 , 14.3 , 14.4 , and 14.5) ] . Table 11 Trials Conducted with SOVALDI with Peginterferon Alfa and/or Ribavirin in Subjects with Chronic HCV Genotype 1, 2, 3, or 4 Infection Trial Population Study Arms (Number of Subjects Treated) NEUTRINO Open label.

(NCT01641640) Treatment naïve (TN) (GT1, 4, 5 or 6) SOVALDI+Peg-IFN alfa+RBV 12 weeks (327) FISSION (NCT01497366) TN (GT2 or 3) SOVALDI+RBV 12 Weeks (256) Peg-IFN alfa+RBV 24 weeks (243) POSITRON Double-blind, placebo-controlled. (NCT01542788) Interferon intolerant, ineligible or unwilling subjects (GT2 or 3) SOVALDI+RBV 12 Weeks (207) Placebo 12 weeks (71) FUSION (NCT01604850) Previous interferon relapsers or nonresponders (GT2 or 3) SOVALDI+RBV 12 Weeks (103) SOVALDI+RBV 16 Weeks (98) VALENCE (NCT01682720) TN or previous interferon relapsers or nonresponders (GT2 or 3) SOVALDI+RBV 12 Weeks for GT2 (73) SOVALDI+RBV 12 Weeks for GT3 (11) SOVALDI+RBV 24 Weeks for GT3 (250) Placebo for 12 weeks (85) PHOTON-1 (NCT01667731) HCV/HIV-1 coinfected TN (GT1) HCV/HIV-1 coinfected TN or previous interferon relapsers or nonresponders (GT2 or 3) SOVALDI+RBV 24 Weeks for GT1 (114) SOVALDI+RBV 12 Weeks for GT2 or 3 TN (68) SOVALDI+RBV 24 Weeks for GT2 or 3 previous interferon relapsers or nonresponders (41) 1112 (NCT02175758) GT2 or GT3 pediatric subjects 3 years of age and older SOVALDI+RBV 12 Weeks for GT2 (31) SOVALDI+RBV 24 Weeks for GT3 (75) Subjects in the adult trials did not have cirrhosis or had compensated cirrhosis.

SOVALDI was administered at a dose of 400 mg once daily. The ribavirin (RBV) dosage for adult subjects was weight-based at 1000–1200 mg daily administered in two divided doses when used in combination with SOVALDI, and the peginterferon alfa 2a dosage, where applicable, was 180 micrograms per week. Treatment duration was fixed in each trial and was not guided by subjects' HCV RNA levels (no response guided algorithm).

Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System. The assay had a lower limit of quantification (LLOQ) of 25 IU per mL. Sustained virologic response (SVR12) was the primary endpoint which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment.

14.2Clinical Trials in Subjects with Genotype 1 or 4 HCV Treatment-Naïve Adults ─ NEUTRINO (Study 110) NEUTRINO was an open-label, single-arm trial that evaluated 12 weeks of treatment with SOVALDI in combination with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 1, 4, 5 or 6 HCV infection compared to pre-specified historical control. Treated subjects (N=327) had a median age of 54 years (range: 19 to 70); 64% of the subjects were male; 79% were White, 17% were Black; 14% were Hispanic or Latino; mean body mass index was 29 kg/m 2 (range: 18 to 56 kg/m 2 ); 78% had baseline HCV RNA greater than 6 log 10 IU per mL; 17% had cirrhosis; 89% had HCV genotype 1; 9% had HCV genotype 4 and 2% had HCV genotype 5 or 6.

Table 12 presents the SVR12 for the treatment group of SOVALDI + peginterferon alfa + ribavirin in subjects with genotype 1 or 4 HCV. Available data on subjects with genotype 5 or 6 HCV treated with SOVALDI + peginterferon alfa + ribavirin for 12 weeks were insufficient for dosing recommendations; therefore these results are not presented in Table 12 [see Use in Specific Populations (8.10) ] . Table 12 Study NEUTRINO: SVR12 for Treatment-Naïve Subjects with Genotype 1 or 4 HCV SOVALDI + Peg-IFN alfa + RBV 12 weeks N=320 Overa… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis Use with Ribavirin and/or Peginterferon alfa: Refer to prescribing information for ribavirin and/or peginterferon alfa for information on carcinogenesis and mutagenesis. Sofosbuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays. Two-year carcinogenicity studies in mice and rats were conducted with sofosbuvir.

Mice were administered doses of up to 200 mg/kg/day in males and 600 mg/kg/day in females, while rats were administered doses of up to 750 mg/kg/day in males and females. No increase in the incidence of drug-related neoplasms were observed at the highest doses tested in mice and rats, resulting in AUC exposure to the predominant circulating metabolite GS-331007 of approximately 7 and 30 times (in mice) and 13 and 17 times (in rats), in males and females respectively, the exposure in humans at the recommended clinical dose.

Impairment of Fertility Use with Ribavirin and/or Peginterferon alfa: Refer to prescribing information for ribavirin and/or peginterferon alfa for information on impairment of fertility. Sofosbuvir had no effects on embryo-fetal viability or on fertility when evaluated in rats. At the highest dose tested, AUC exposure to the predominant circulating metabolite GS-331007 was approximately 8 times the exposure in humans at the recommended clinical dose.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis Use with Ribavirin and/or Peginterferon alfa: Refer to prescribing information for ribavirin and/or peginterferon alfa for information on carcinogenesis and mutagenesis. Sofosbuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays. Two-year carcinogenicity studies in mice and rats were conducted with sofosbuvir.

Mice were administered doses of up to 200 mg/kg/day in males and 600 mg/kg/day in females, while rats were administered doses of up to 750 mg/kg/day in males and females. No increase in the incidence of drug-related neoplasms were observed at the highest doses tested in mice and rats, resulting in AUC exposure to the predominant circulating metabolite GS-331007 of approximately 7 and 30 times (in mice) and 13 and 17 times (in rats), in males and females respectively, the exposure in humans at the recommended clinical dose.

Impairment of Fertility Use with Ribavirin and/or Peginterferon alfa: Refer to prescribing information for ribavirin and/or peginterferon alfa for information on impairment of fertility. Sofosbuvir had no effects on embryo-fetal viability or on fertility when evaluated in rats. At the highest dose tested, AUC exposure to the predominant circulating metabolite GS-331007 was approximately 8 times the exposure in humans at the recommended clinical dose.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 03/2020 Patient Information SOVALDI ® (soh-VAHL-dee) (sofosbuvir) tablets SOVALDI ® (soh-VAHL-dee) (sofosbuvir) oral pellets Important: SOVALDI is used in combination with other antiviral medicines.

When taking SOVALDI with ribavirin or in combination with peginterferon alfa and ribavirin you should also read those Medication Guides. The information in this Patient Information Leaflet talks about SOVALDI when it is used with ribavirin and in combination with peginterferon alfa and ribavirin. What is the most important information I should know about SOVALDI?

SOVALDI can cause serious side effects, including: Hepatitis B virus reactivation: Before starting treatment with SOVALDI, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with SOVALDI. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death.

Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking SOVALDI. For more information about side effects, see the section " What are the possible side effects of SOVALDI? " What is SOVALDI? SOVALDI is a prescription medicine used with other antiviral medicines to treat adults with chronic (lasting a long time) hepatitis C virus (HCV): genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis in combination with peginterferon alfa and ribavirin genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis in combination with ribavirin SOVALDI is used to treat children 3 years of age and older with chronic HCV genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis in combination with ribavirin.

It is not known if SOVALDI is safe and effective in children under 3 years of age with HCV genotype 2 or 3 infection, or with HCV genotype 1 or 4 infection. It is not known if SOVALDI is safe and effective in people who have had a liver transplant. Before taking SOVALDI, tell your healthcare provider about all of your medical conditions, including if you: have ever had hepatitis B virus infection have liver problems other than hepatitis C infection have had a liver transplant have severe kidney problems or you are on dialysis have HIV infection are pregnant or plan to become pregnant.

It is not known if SOVALDI will harm your unborn baby. Males and females who take SOVALDI in combination with ribavirin should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information. are breastfeeding or plan to breastfeed. It is not known if SOVALDI passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby during treatment with SOVALDI. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOVALDI and other medicines may affect each other.

This can cause you to have too much or not enough SOVALDI or other medicines in your body. This may affect the way SOVALDI or your other medicines work, or may cause side effects. Keep a list of your medicines to show your healthcare provider and pharmacist.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with SOVALDI. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take SOVALDI with other medicines.

How should I take SOVALDI? Take SOVALDI exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.

Do not stop taking SOVALDI without first talking with your healthcare provider. T… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE SOVALDI ® (soh-VAHL-dee) (sofosbuvir) pellets, for oral use Read the Patient Information that comes with SOVALDI oral pellets for important information about SOVALDI. This Instructions for Use contains information on how to take SOVALDI oral pellets. Be sure you understand and follow the instructions.

If you have any questions, ask your healthcare provider or pharmacist. Important Information You Need to Know Before Taking SOVALDI oral pellets For oral use only (take by mouth with or without food). Do not open the SOVALDI oral pellet packet(s) until ready to use.

SOVALDI oral pellets are white to off-white pellets supplied as single-use packets in cartons. Each carton contains 28 packets. Do not use SOVALDI oral pellets if the carton tamper-evident seal, or the pellets packet seal, is broken or damaged.

Preparing a dose of SOVALDI oral pellets to be taken with food: Before you prepare a dose of SOVALDI oral pellets to be taken with food, gather the following supplies: Daily SOVALDI oral pellet packet(s), as prescribed by your healthcare provider One or more spoonfuls of non-acidic soft food such as pudding, chocolate syrup, mashed potato, or ice cream Bowl Spoon Scissors (optional) Step 1: Add one or more spoonfuls of non-acidic soft food to the bowl first. Step 2: Hold the SOVALDI oral pellets packet with the cut line on top (see Figure A ).

Step 3: Shake the packet gently to settle the pellets to the bottom of the packet (see Figure B ). Figure A Figure B Step 4: Cut the packet along the cut line with scissors (see Figure C ), or fold the packet back at the tear line (see Figure D ) and tear open (see Figure E ). Figure C Figure D Figure E Step 5: Carefully pour the entire contents of the prescribed number of SOVALDI oral pellet packet(s) onto the food in the bowl and gently mix with a spoon (see Figure F ).

Make sure that no SOVALDI oral pellets remain in the packet(s). Figure F Step 6: Take the SOVALDI oral pellets and food mixture within 30 minutes without chewing to avoid a bitter taste. Ensure all of the SOVALDI oral pellets are taken.

Preparing a dose of SOVALDI oral pellets to be taken without food: Before you prepare a dose of SOVALDI oral pellets to be taken without food, gather the following supplies: Daily SOVALDI oral pellet packet(s), as prescribed by your healthcare provider Scissors (optional) Water (optional) Step 1: Hold the SOVALDI oral pellets packet with the cut line on top (see Figure G ). Step 2: Shake the packet gently to settle the pellets to the bottom of the packet (see Figure H ). Figure G Figure H Step 3: Cut the packet along the cut line with scissors (see Figure I ), or fold the packet back at the tear line (see Figure J ) and tear open (see Figure K ).

Figure I Figure J Figure K Step 4: Pour the entire contents of the SOVALDI oral pellets packet directly in the mouth and swallow without chewing to avoid a bitter taste (see Figure L ). Water may be taken after swallowing the pellets, if needed. Make sure that no SOVALDI oral pellets remain in the packet.

If your healthcare provider prescribed more than one SOVALDI oral pellets packet, repeat Steps 1 through 4. Figure L Storing SOVALDI oral pellets Store SOVALDI pellets below 86°F (30°C). Keep SOVALDI oral pellets and all medicines out of the reach of children.

Disposing of SOVALDI oral pellets Throw away any unused portion. Do not store and reuse any leftover SOVALDI mixture (pellets mixed with food). For more information, call 1-800-445-3235 or go to www.SOVALDI.com.

Manufactured for and distributed by: Gilead Sciences, Inc., Foster City, CA 94404 SOVALDI is a trademark of Gilead Sciences, Inc., or its related companies. © 2024 Gilead Sciences, Inc. All rights reserved. 204671-GS-011 This Instructions for Use has been approved by the U.S.

Food and Drug Administration. Issued: March 2020 Figure A Figure B Figure C Image Figure D Figure E Figure F Figure G Figure H Figure I Image Figure J Figure K Figure L

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label NDC 61958-1501-1 28 tablets Sovaldi ® (sofosbuvir) tablets 400 mg Take 1 tablet once daily Note to pharmacist: Do not cover ALERT box with pharmacy label. ALERT: Find out about medicines that should NOT be taken with Sovaldi PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label NDC 61958-1503-1 28 tablets Sovaldi ® (sofosbuvir) tablets 200 mg Take 1 tablet once daily Note to pharmacist: Do not cover ALERT box with pharmacy label. ALERT: Find out about medicines that should NOT be taken with Sovaldi PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 150 mg Pellet Packet Carton Label NDC 61958- 1504 -1 28 packets Sovaldi ® (sofosbuvir) oral pellets 150 mg per packet Rx only Note to pharmacist: Do not cover ALERT box with pharmacy label. ALERT: Find out about medicines that should NOT be taken with Sovaldi PRINCIPAL DISPLAY PANEL - 150 mg Pellet Packet Carton Label

PRINCIPAL DISPLAY PANEL - 200 mg Pellet Packet Carton Label NDC 61958- 1505 -1 28 packets Sovaldi ® (sofosbuvir) oral pellets 200 mg per packet Rx only Note to pharmacist: Do not cover ALERT box with pharmacy label. ALERT: Find out about medicines that should NOT be taken with Sovaldi PRINCIPAL DISPLAY PANEL - 200 mg Pellet Packet Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sovaldi — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sovaldi. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$492.3K
Claims incl. refills
19
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$25,908.55
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sovaldi (this brand).

Top reported reactions

Fatigue2,314
Hepatitis C1,736
Headache1,644
Nausea1,395
Anaemia1,188
Insomnia1,061
Hepatocellular Carcinoma911

Reporter sex

19,615 reports
Male · 61%
Female · 39%
Unknown · 0%

Serious outcomes

Hospitalization4,451
Death1,797
Life-threatening591
Disabling247
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,127 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Gilead Sciences, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gilead Sciences, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 61958-1401-01 · Gilead 61958-1503-01 · Gilead →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.