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Mavyret Glecaprevir and Pibrentasvir 20 mg; 50 mg Pellet — NDC 00074-2600-28 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mavyret Glecaprevir and Pibrentasvir 20 mg; 50 mg Pellet — NDC 0074-2600-28 (Billing 00074-2600-28)

by AbbVie Inc. · 1 PACKET in 1 CARTON / 28 PELLET in 1 PACKET

This is a package of Mavyret Glecaprevir and Pibrentasvir 20 mg; 50 mg Pellet from AbbVie Inc., marketed since Jun 2021 and currently FDA-listed. It is this product's only package size.

NDC 00074-2600-28
🏷️ FDA NDC (as labeled) 0074-2600-28 billing pads the labeler 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 Oct 8, 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 0074-2600-28 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0074 labeler · 2600 product · 28 package
Package marketed since
Jun 22, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0074260028 6
Medicaid fills, this package
28 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0074-2600-28
Product NDC 0074-2600
11-digit billing NDC 00074260028
NCPDP billing unit EA — each (per item)
RxCUI 1940703, 1940709, 2557906, 2557910
UNII 2WU922TK3L, K6BUU8J72P
Application # NDA215110
SPL Set ID 7bf99777-0401-9095-8645-16c6e907fcc0
Established class (EPC) Hepatitis C Virus NS5A Inhibitor; Hepatitis C Virus NS3/4A Protease Inhibitor
Mechanism of action P-Glycoprotein Inhibitors; Breast Cancer Resistance Protein Inhibitors; Organic Anion Transporting Polypeptide 1B1 Inhibitors; Organic Anion Transporting Polypeptide 1B3 Inhibitors; Cytochrome P450 3A Inhibitors; Cytochrome P450 1A2 Inhibitors; UGT1A1 Inhibitors; HCV NS3/4A Protease Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-10
Route ORAL
Dosage form PELLET
Substance PIBRENTASVIR; GLECAPREVIR

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

GCN Seq No 082438
GCN 49863
HICL code 044453
Ingredient (HICL) Glecaprevir/Pibrentasvir
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W0
Therapeutic class — intermediate (HIC2) Antiviral Agents (Continued 1)
HIC3 code W0E
Therapeutic class — specific (HIC3) Hepatitis C Virus- Ns5A And Ns3/4A Inhibitor Comb
AHFS code 08:18.40.20
AHFS class Hcv Protease Inhibitor Antivirals
FDB label name MAVYRET 50-20 MG PELLET PACKET
FDB brand name Mavyret
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 082438
  • GCN: 49863
  • HICL (First Databank): 044453
  • AHFS class code: 08:18.40.20
  • RxCUI (RxNorm): 1940703
Why two NDCs? The FDA registers this code as 0074-2600-28 — a 4-4-2 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 labeler segment → 00074-2600-28. 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 NS3/4A Protease Inhibitor class.

Pharmacologic class Hepatitis C Virus NS3/4A Protease Inhibitor
Drug family (ATC) Antivirals for treatment of HCV infections
How it works Cytochrome P450 1A2 Inhibitors, HCV NS3/4A Protease Inhibitors, P-Glycoprotein Inhibitors, Organic Anion Transporting Polypeptide 1B1 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 MAVYRET 50-20 MG PELLET PACKET Ingredient Glecaprevir/Pibrentasvir
📖 What it is MedlinePlus · NLM

The combination of glecaprevir and pibrentasvir is used to treat certain types of chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus) in adults and children 3 years of age and older. It is also used to treat certain types of chronic hepatitis C infection in adults and children 3 years of age and older who have already received another medication to treat their hepatitis C infection. Glecaprevir is in a class of medications called HCV NS3/4A protease inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. Pibrentasvir is in a class o...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats hepatitis C virus infection, genotypes 1 to 6, in adults and children 3 and older. It can be used if you have no cirrhosis or compensated cirrhosis. Your doctor picks the...
  • Take it once a day with food. Tablets are swallowed together at the same time. For younger children, the pellets are sprinkled on soft, sticky food and swallowed without chewing. F...
  • Most people have mild ones like headache, tiredness and nausea. Diarrhea and itching can happen too. Call your doctor if you notice yellow skin or eyes, belly swelling, confusion,...
  • Treating hepatitis C can reactivate hepatitis B if you have it now or had it before. That can cause serious liver injury. Testing lets your doctor monitor or treat hepatitis B.
📖 Read our full Glecaprevir and Pibrentasvir guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $88.51 $2,478.30 / 28 pellets
Medicare drug plans payPart D · Q2 2026 $96.00 $2,688.11 / 28 pellets
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
00074-2600-28 You're viewing this Main listing 1 PACKET in 1 CARTON / 28 PELLET in 1 PACKET 2021-06-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mavyret 20 mg/1; 50 mgthis 00074-2600-28 AbbVie 1 packet — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2021
First FDA approval
Jun 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 10, 2021 RLD RS ⏳ ~9.2 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.

When could a generic Mavyret arrive?

Our estimate: December 2036 about 10 years away

How sure: Probable. More likely than not, but it can still move.

Why then: A patent that protects the brand runs out. After that, approved generics can be sold.

See the full forecast for generic Mavyret →
Patents & exclusivity — FDA Orange Book
US 10286029 — method of use (U-4206)
US 10039754 — method of use (U-4206)
US 10028937 — method of use (U-4206)
US 9586978 — method of use (U-4206)
US 8648037 — drug substance (U-4206)
US 9586978 — method of use (U-3238)
US 8648037 — drug substance (U-3238)
US 10028937 — method of use (U-3238)
US 10039754 — method of use (U-3238)
US 10286029 — method of use (U-3238)
US 8937150 — drug substance
US 9321807 — drug substance
US RE48923 — drug substance
US RE48923*PED — drug product
US 10028937*PED — drug product
US 10039754*PED — drug product
US 9586978*PED — drug product
US 8648037*PED — drug product
US 10286029*PED — drug product
US 8937150*PED — drug product
US 9321807*PED — drug product
Exclusivity I-967
Exclusivity ODE-372
Exclusivity PED
2021 2023 2025 2027 2029 2031 2033 2035
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 (21)
PatentTypeUse codeExpires
US 10286029 ↗ Method of use U-4206 Mar 14, 2034
US 10039754 ↗ Method of use U-4206 Jun 10, 2030
US 10028937 ↗ Method of use U-4206 Jun 10, 2030
US 9586978 ↗ Method of use U-4206 Nov 6, 2030
US 8648037 ↗ Drug substance U-4206 Jan 19, 2032
US 9586978 ↗ Method of use U-3238 Nov 6, 2030
US 8648037 ↗ Drug substance U-3238 Jan 19, 2032
US 10028937 ↗ Method of use U-3238 Jun 10, 2030
US 10039754 ↗ Method of use U-3238 Jun 10, 2030
US 10286029 ↗ Method of use U-3238 Mar 14, 2034
US 8937150 ↗ Drug substance — May 18, 2032
US 9321807 ↗ Drug substance — Jun 5, 2035
US RE48923 ↗ Drug substance — May 8, 2035
US RE48923*PED ↗ Drug product — Nov 8, 2035
US 10028937*PED ↗ Drug product — Dec 10, 2030
US 10039754*PED ↗ Drug product — Dec 10, 2030
US 9586978*PED ↗ Drug product — May 6, 2031
US 8648037*PED ↗ Drug product — Jul 19, 2032
US 10286029*PED ↗ Drug product — Sep 14, 2034
US 8937150*PED ↗ Drug product — Nov 18, 2032
US 9321807*PED ↗ Drug product — Dec 5, 2035
FDA exclusivity
CodeWhat it grantsExpires
I-967New indication (3-year)Jun 10, 2028
ODE-372Orphan Drug Exclusivity (7-year)Jun 10, 2028
PEDPediatric Exclusivity (+6 months)Dec 10, 2028
Common questions
Is there a generic version of MAVYRET 50-20 MG PELLET PACKET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for MAVYRET 50-20 MG PELLET PACKET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2035 — an estimate, not a guaranteed launch date. We expect the first generic Mavyret in December 2036, about 10 years away. See the forecast.
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 pink / yellow
ShapeRound
ImprintNXT
Size19 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 Glecaprevir and Pibrentasvir 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 D9C330MD8B
    Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
  • 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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • 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 36SFW2JZ0W
    Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII RT9P9S09QI
    Propylene glycol monocaprylate is a synthetic compound made by combining propylene glycol with a fatty acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients together in medicines and improve how the body absorbs the active drug.
  • 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 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • 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 O03S90U1F2
    A synthetic compound combining vitamin E with polyethylene glycol and succinic acid. It acts as a solubilizer and antioxidant in medicines, helping dissolve poorly water-soluble drugs and prevent degradation of active ingredients.

12 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

LabelerAbbVie Inc.
Application holderABBVIE INC
FDA applicationNDA215110 (NDA)
Labeler code00074
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio138 products on file

More NDCs from AbbVie Inc. labeler code 00074

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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 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 MAVYRET. 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 202 words ▾

1 INDICATIONS AND USAGE MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14 )].

MAVYRET is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

( 1 )

⏱️ 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 ) See recommended treatment duration for patients 3 years and older in tables below. ( 2.2 ) Treatment-Naïve Patients 1 HCV Genotype Treatment Duration No Cirrhosis Compensated Cirrhosis (Child-Pugh A) 1, 2, 3, 4, 5, or 6 8 weeks 8 weeks Treatment-naïve patients are those who have not received treatment for the current infection.

Treatment-Experienced Patients 1 Treatment Duration HCV Genotype Patients Previously Treated With a Regimen Containing: No Cirrhosis Compensated Cirrhosis (Child-Pugh A) 1 An NS5A inhibitor 2 without prior treatment with an NS3/4A protease inhibitor (PI) 16 weeks 16 weeks An NS3/4A PI 3 without prior treatment with an NS5A inhibitor 12 weeks 12 weeks 1, 2, 4, 5, or 6 PRS 4 8 weeks 12 weeks 3 PRS 4 16 weeks 16 weeks Treatment-experienced patients are those who previously received treatment for the current infection. Treated with prior regimens containing ledipasvir and sofosbuvir or daclatasvir with (peg) interferon and ribavirin.

Treated with prior regimens containing simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with (peg) interferon and ribavirin. PRS=Prior treatment experience with regimens containing (peg) interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor. Recommended dosage in adults: Three tablets taken at the same time orally once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) with food.

( 2.3 ) Recommended dosage in pediatric patients 3 years and older: Pediatric Patients 3 Years to Less than 12 Years Old: Dosing is based on weight. Refer to Table 3 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 MAVYRET oral pellets.

( 2.5 ) Pediatric Patients 12 Years of Age and Older, or Pediatric Patients Weighing at Least 45 kg: three tablets taken at the same time orally once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) with food. ( 2.4 ) HCV/HIV-1 co-infection and patients with any degree of renal impairment: Follow the dosage recommendations in the tables above. ( 2.2 ) Liver or Kidney Transplant Recipients: MAVYRET is recommended for 12 weeks in patients 3 years and older who are liver or kidney transplant recipients.

A 16-week treatment duration is recommended in genotype 1-infected patients who are NS5A inhibitor-experienced without prior treatment with an NS3/4A PI or in genotype 3-infected patients who are PRS treatment-experienced. ( 2.6 )

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 MAVYRET [see Warnings and Precautions ( 5.1 ) ] .

2.2Recommended Treatment Duration in Patients 3 Years and Older Tables 1 and 2 provide the recommended MAVYRET treatment duration based on the patient population in HCV mono-infected and HCV/HIV-1 co-infected patients with compensated liver disease (with or without cirrhosis) and with or without renal impairment including patients receiving dialysis [see Contraindications ( 4 ) and Clinical Studies ( 14 )] . Refer to Drug Interactions ( 7 ) for dosage recommendations for concomitant HIV-1 antiviral drugs. Table 1.

Recommended Duration for Treatment-Naïve Patients 1 HCV Genotype Treatment Duration No Cirrhosis Compensated Cirrhosis (Child-Pugh A) 1, 2, 3, 4, 5, or 6 8 weeks 8 weeks 1. Treatment-naïve patients are those who have not received treatment for the current infection. Table 2.

Recommended Duration for Treatment-Experienced Patients 1 Treatment Duration HCV Genotype Patients Previously Treated with a Regimen Containing: No Cirrhosis Compensated Cirrhosis (Child-Pugh A)… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 80 words ▾

3 DOSAGE FORMS AND STRENGTHS MAVYRET is available as tablets or pellets for oral use. Tablets: pink, oblong-shaped, film-coated, and debossed with “NXT” on one side. Each tablet contains 100 mg glecaprevir and 40 mg of pibrentasvir.

Oral pellets: pink and yellow coated pellets in unit-dose packets. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir. Tablets: 100 mg glecaprevir and 40 mg pibrentasvir.

( 3 ) Oral Pellets: 50 mg glecaprevir and 20 mg pibrentasvir. ( 3 )

⛔ Contraindications 100 words ▾

4 CONTRAINDICATIONS MAVYRET is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . MAVYRET is contraindicated with atazanavir or rifampin [see Drug Interaction ( 7.3 ) and Clinical Pharmacology ( 12.3 )] . Patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation.

( 4 , 5.2 ) Coadministration with atazanavir or rifampin. ( 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 ) Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease: Hepatic decompensation/failure, including fatal outcomes, have been reported mostly in patients with cirrhosis and baseline moderate or severe liver impairment (Child-Pugh B or C). Monitor for clinical and laboratory evidence of hepatic decompensation. Discontinue MAVYRET in patients who develop evidence of hepatic decompensation/failure.

( 5.2 )

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., increase 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 MAVYRET. In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment with MAVYRET and during post-treatment follow-up.

Initiate appropriate patient management for HBV infection as clinically indicated.

5.2Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease Postmarketing cases of hepatic decompensation/failure, including those with fatal outcomes, have been reported in patients treated with HCV NS3/4A protease inhibitor-containing regimens, including MAVYRET. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The majority of patients with severe outcomes had evidence of advanced liver disease with moderate or severe hepatic impairment (Child-Pugh B or C) prior to initiating therapy with MAVYRET, including some patients reported as having compensated cirrhosis with mild liver impairment (Child-Pugh A) at baseline but with a prior decompensation event (i.e., prior history of ascites, variceal bleeding, encephalopathy).

Rare cases of hepatic decompensation/failure were reported in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A); many of these patients had evidence of portal hypertension. Events also occurred in patients taking a concomitant medication not recommended for coadministration, or in patients with confounding factors such as serious liver-related medical or surgical comorbidities. Cases typically occurred within the first 4 weeks of treatment (median of 27 days).

In patients with compensated cirrhosis (Child-Pugh A) or evidence of advanced liver disease such as portal hypertension, perform hepatic labo… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS In subjects receiving MAVYRET, the most commonly reported adverse reactions (greater than 10%) are headache and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 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 clinical trials of MAVYRET cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overall Adverse Reactions in Subjects with Chronic HCV Infection without Cirrhosis or with Compensated Cirrhosis (Child-Pugh A) The adverse reactions data for MAVYRET in subjects without cirrhosis or with compensated cirrhosis (Child-Pugh A) were derived from nine registrational Phase 2 and 3 trials which evaluated approximately 2,300 adults infected with genotype 1, 2, 3, 4, 5, or 6 HCV who received MAVYRET for 8, 12 or 16 weeks [see Clinical Studies ( 14 ) ] .

The overall proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.1% for subjects who received MAVYRET for 8, 12 or 16 weeks. The most common adverse reactions, all grades, observed in greater than or equal to 5% of subjects receiving 8, 12, or 16 weeks of treatment with MAVYRET were headache (13%), fatigue (11%), and nausea (8%). In subjects receiving MAVYRET who experienced adverse reactions, 80% had an adverse reaction of mild severity (Grade 1).

One subject experienced a serious adverse reaction. Adverse reactions (type and severity) were similar for subjects receiving MAVYRET for 8, 12 or 16 weeks. The type and severity of adverse reactions in subjects with compensated cirrhosis (Child-Pugh A) were similar to those seen in subjects without cirrhosis.

Adverse Reactions in Subjects with Chronic HCV Infection without Cirrhosis ENDURANCE-2 Among 302 treatment-naïve or PRS treatment-experienced, HCV genotype 2-infected adults without cirrhosis enrolled in ENDURANCE-2, adverse reactions (all intensity) occurring in at least 5% of subjects treated with MAVYRET for 12 weeks are presented in Table 4 . In subjects treated with MAVYRET for 12 weeks, 32% reported an adverse reaction, of which 98% had adverse reactions of mild or moderate severity. No subjects treated with MAVYRET or placebo in ENDURANCE-2 permanently discontinued treatment due to an adverse drug reaction.

Table 4. Adverse Reactions Reported in ≥5% of Treatment-Naïve and PRS-Experienced Adults without Cirrhosis Receiving MAVYRET for 12 Weeks in ENDURANCE-2 Adverse Reaction MAVYRET 12 Weeks (N = 202) % Placebo 12 Weeks (N = 100) % Headache 9 6 Nausea 6 2 Diarrhea 5 2 ENDURANCE-3 Among 505 treatment-naïve, HCV genotype 3-infected adults without cirrhosis enrolled in ENDURANCE-3, adverse reactions (all intensity) occurring in at least 5% of subjects treated with MAVYRET for 8 or 12 weeks are presented in Table 5 . In subjects treated with MAVYRET, 45% reported an adverse reaction, of which 99% had adverse reactions of mild or moderate severity.

The proportion of subjects who permanently discontinued treatment due to adverse reactions was 0%, < 1% and 1% for the MAVYRET 8-week arm, MAVYRET 12 week arm and DCV + SOF arm, respectively. Table 5. Adverse Reactions Reported in ≥5% of Treatment-Naïve Adults without Cirrhosis Receiving MAVYRET for 8 Weeks or 12 Weeks in ENDURANCE-3 Adverse Reaction MAVYRET* 8 Weeks (N = 157) % MAVYRET 12 Weeks (N = 233) % DCV 1 + SOF 2 12 Weeks (N = 115) % Headache 16 17 15 Fatigue 11 14 12 Nausea 9 12 12 Diarrhea 7 3 3 1 DCV=daclatasvir 2 SOF=sofosbuvir * The 8-week arm was a non-randomized treatment arm.

Adverse Reactions in Subjects with Chronic HCV Infection with Compensated Cirrhosis (Child-Pugh A) The safety of MAVYRET in HCV GT 1, 2, 3, 4, 5, or 6 subjects with compensated cirrhosis is based on data from 288 adults from the Phase 2/3 registrational trials treated with MAVYRET for 12 or… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Carbamazepine, efavirenz, and St. John’s wort may decrease concentrations of glecaprevir and pibrentasvir. Coadministration of carbamazepine, efavirenz containing regimens, and St.

John’s wort with MAVYRET is not recommended. ( 5.3 ) 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.

( 7.3 ) Medication- Assisted Treatment (MAT) for Opioid Use Disorder. ( 7.4 ) Consult the full prescribing information prior to and during treatment for potential drug interactions. ( 4 , 7 , 12.3 )

7.1Mechanisms for the Potential Effect of MAVYRET on Other Drugs Glecaprevir and pibrentasvir are inhibitors of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide (OATP) 1B1/3. Coadministration with MAVYRET may increase plasma concentration of drugs that are substrates of P-gp, BCRP, OATP1B1 or OATP1B3. Glecaprevir and pibrentasvir are weak inhibitors of cytochrome P450 (CYP) 3A, CYP1A2, and uridine glucuronosyltransferase (UGT) 1A1.

7.2Mechanisms for the Potential Effect of Other Drugs on MAVYRET Glecaprevir and pibrentasvir are substrates of P-gp and/or BCRP. Glecaprevir is a substrate of OATP1B1/3. Coadministration of MAVYRET with drugs that inhibit hepatic P-gp, BCRP, or OATP1B1/3 may increase the plasma concentrations of glecaprevir and/or pibrentasvir.

Coadministration of MAVYRET with drugs that induce P-gp/CYP3A may decrease glecaprevir and pibrentasvir plasma concentrations. Carbamazepine, phenytoin, efavirenz, and St. John’s wort may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect of MAVYRET.

The use of these agents with MAVYRET is not recommended [see Warnings and Precautions ( 5.3 ) and Clinical Pharmacology ( 12.3 )] .

7.3Established and Other Potential Drug Interactions 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 CYP 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.

Table 6 provides the effect of MAVYRET on concentrations of coadministered drugs and the effect of coadministered drugs on glecaprevir and pibrentasvir [see Contraindications ( 4 ) , Warnings and Precautions ( 5.3 ) , and Clinical Pharmacology ( 12.3 ) ] . All interaction studies were performed in adults. Table 6.

Potentially Significant Drug Interactions Identified in Drug Interaction Studies Concomitant Drug Class: Drug Name Effect on Concentration Clinical Comments Antiarrhythmics: Digoxin ↑ digoxin Measure serum digoxin concentrations before initiating MAVYRET. Reduce digoxin concentrations by decreasing the dose by approximately 50% or by modifying the dosing frequency and continue monitoring. Anticoagulants: Dabigatran etexilate ↑ dabigatran If MAVYRET and dabigatran etexilate are coadministered, refer to the dabigatran etexilate prescribing information for dabigatran etexilate dose modifications in combination with P-gp inhibitors in the… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary No adequate human data are available to establish whether or not MAVYRET poses a risk to pregnancy outcomes. In animal reproduction studies, no adverse developmental effects were observed when the components of MAVYRET were administered separately during organogenesis at exposures up to 53 times (rats; glecaprevir) or 51 and 1.5 times (mice and rabbits, respectively; pibrentasvir) the human exposures at the recommended dose of MAVYRET (see Data ) . No definitive conclusions regarding potential developmental effects of glecaprevir could be made in rabbits, since the highest achieved glecaprevir exposure in this species was only 7% (0.07 times) of the human exposure at the recommended dose.

There were no effects with either compound in rodent pre/post-natal developmental studies in which maternal systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 47 and 74 times, respectively, the exposure in humans at the recommended dose (see Data ) . 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% to 4% and 15% to 20%, respectively.

Data Glecaprevir Glecaprevir was administered orally to pregnant rats (up to 120 mg/kg/day) and rabbits (up to 60 mg/kg/day) during the period of organogenesis (gestation days (GD) 6 to 18, and GD 7 to 19, respectively). No adverse embryo-fetal effects were observed in rats at dose levels up to 120 mg/kg/day (53 times the exposures in humans at the recommended human dose (RHD)). In rabbits, the highest glecaprevir exposure achieved was 7% (0.07 times) of the exposure in humans at RHD.

As such, data in rabbits during organogenesis are not available for glecaprevir systemic exposures at or above the exposures in humans at the RHD. In the pre/post-natal developmental study in rats, glecaprevir was administered orally (up to 120 mg/kg/day) from GD 6 to lactation day 20. No effects were observed at maternal exposures 47 times the exposures in humans at the RHD.

Pibrentasvir Pibrentasvir was administered orally to pregnant mice and rabbits (up to 100 mg/kg/day) during the period of organogenesis (GD 6 to 15, and GD 7 to 19, respectively). No adverse embryo-fetal effects were observed at any studied dose level in either species. The systemic exposures at the highest doses were 51 times (mice) and 1.5 times (rabbits) the exposures in humans at the RHD.

In the pre/post-natal developmental study in mice, pibrentasvir was administered orally (up to 100 mg/kg/day) from GD 6 to lactation day 20. No effects were observed at maternal exposures approximately 74 times the exposures in humans at the RHD.

8.2Lactation Risk Summary It is not known whether the components of MAVYRET are excreted in human breast milk, affect human milk production, or have effects on the breastfed infant. When administered to lactating rodents, the components of MAVYRET were present in milk, without effect on growth and development observed in the nursing pups (see Data ) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MAVYRET and any potential adverse effects on the breastfed child from MAVYRET or from the underlying maternal condition.

Data No significant effects of glecaprevir or pibrentasvir on growth and post-natal development were observed in nursing pups at the highest doses tested (120 mg/kg/day for glecaprevir and 100 mg/kg/day for pibrentasvir). Maternal systemic exposure (AUC) to glecaprevir and pibrentasvir was approximately 47 or 74 times the exposure in humans at the RHD. Systemic exposure in nursing pups on post-natal day 14 was approximately 0.6 to 2.2 % of the maternal exposure for glecaprevir and approximately one quarter to one third of the maternal exposure for pibrentasvir.

Glecaprevir or… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary No adequate human data are available to establish whether or not MAVYRET poses a risk to pregnancy outcomes. In animal reproduction studies, no adverse developmental effects were observed when the components of MAVYRET were administered separately during organogenesis at exposures up to 53 times (rats; glecaprevir) or 51 and 1.5 times (mice and rabbits, respectively; pibrentasvir) the human exposures at the recommended dose of MAVYRET (see Data ) . No definitive conclusions regarding potential developmental effects of glecaprevir could be made in rabbits, since the highest achieved glecaprevir exposure in this species was only 7% (0.07 times) of the human exposure at the recommended dose.

There were no effects with either compound in rodent pre/post-natal developmental studies in which maternal systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 47 and 74 times, respectively, the exposure in humans at the recommended dose (see Data ) . 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% to 4% and 15% to 20%, respectively.

Data Glecaprevir Glecaprevir was administered orally to pregnant rats (up to 120 mg/kg/day) and rabbits (up to 60 mg/kg/day) during the period of organogenesis (gestation days (GD) 6 to 18, and GD 7 to 19, respectively). No adverse embryo-fetal effects were observed in rats at dose levels up to 120 mg/kg/day (53 times the exposures in humans at the recommended human dose (RHD)). In rabbits, the highest glecaprevir exposure achieved was 7% (0.07 times) of the exposure in humans at RHD.

As such, data in rabbits during organogenesis are not available for glecaprevir systemic exposures at or above the exposures in humans at the RHD. In the pre/post-natal developmental study in rats, glecaprevir was administered orally (up to 120 mg/kg/day) from GD 6 to lactation day 20. No effects were observed at maternal exposures 47 times the exposures in humans at the RHD.

Pibrentasvir Pibrentasvir was administered orally to pregnant mice and rabbits (up to 100 mg/kg/day) during the period of organogenesis (GD 6 to 15, and GD 7 to 19, respectively). No adverse embryo-fetal effects were observed at any studied dose level in either species. The systemic exposures at the highest doses were 51 times (mice) and 1.5 times (rabbits) the exposures in humans at the RHD.

In the pre/post-natal developmental study in mice, pibrentasvir was administered orally (up to 100 mg/kg/day) from GD 6 to lactation day 20. No effects were observed at maternal exposures approximately 74 times the exposures in humans at the RHD.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use No dosage adjustment of MAVYRET is required in pediatric patients 12 years and older or weighing at least 45 kg. The recommended dosage of MAVYRET in pediatric patients 3 to less than 12 years of age is based on weight [see Dosage and Administration ( 2.2 , 2.4 ) , Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.10 ) ] . The safety, efficacy, and pharmacokinetics of MAVYRET in HCV GT1, 2, 3, or 4 infected pediatric patients 3 years and older is based on data from an open-label trial in 127 subjects with chronic HCV infection, without cirrhosis, and aged 3 years to less than 18 years who were either treatment-naïve (n=114) or treatment-experienced (n=13) and received MAVYRET for 8, 12 or 16 weeks (DORA-Part 1 and Part 2).

The adverse reactions observed in subjects 3 years to less than 18 years of age were consistent with those observed in clinical trials of MAVYRET in adults with chronic HCV infection with the exception of vomiting, rash and abdominal pain upper which were observed more frequently in pediatric subjects less than 12 years of age compared to adults [see Adverse Reactions ( 6.1 ) ] . The efficacy results observed in this trial were consistent with those observed in clinical trials of MAVYRET in adults [see Clinical Studies ( 14.10 ) ] .

Use of MAVYRET in pediatric patients with acute HCV infection is supported by extrapolation of safety and efficacy data from adult patients with acute HCV infection and adult and pediatric patients with chronic HCV infection. It is expected that adult and pediatric patients with acute HCV infection have similar disease response to treatment. No clinically meaningful differences in MAVYRET exposures are expected among pediatric patients with acute HCV infection and pediatric patients with chronic HCV infection [see Clinical Pharmacology ( 12.3 )].

In pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or HCV GT5 or 6 infection, the safety and efficacy of MAVYRET are supported by the comparable glecaprevir and pibrentasvir exposures observed between pediatric subjects and adults [see Clinical Pharmacology ( 12.3 ) ] . The safety and effectiveness of MAVYRET in children less than 3 years of age have not been studied.

🧓 Geriatric Use 126 words ▾

8.5Geriatric Use In clinical trials of MAVYRET in subjects with chronic HCV infection, 328 subjects were age 65 years and over (14% of the total number of subjects in the Phase 2 and 3 clinical trials), and 47 (2%) subjects were age 75 and over. In a clinical trial of MAVYRET in subjects with acute HCV infection, 16 subjects were age 65 years and over (6%), and 1 (0.3%) subject was age 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects.

No dosage adjustment of MAVYRET is warranted in geriatric patients [see Clinical Pharmacology ( 12.3 ) ] .

🆘 Overdosage 34 words ▾

10 OVERDOSAGE In case of overdose, the patient should be monitored for any signs and symptoms of toxicities. Appropriate symptomatic treatment should be instituted immediately. Glecaprevir and pibrentasvir are not significantly removed by hemodialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Mechanism of Action MAVYRET is a fixed-dose combination of glecaprevir and pibrentasvir, which are direct-acting antiviral agents against the hepatitis C virus [see Microbiology ( 12.4 ) ] .

12.2Pharmacodynamics Cardiac Electrophysiology The effect of doses up to glecaprevir 600 mg (2 times the recommended dosage) with doses up to pibrentasvir 240 mg (2 times the recommended dosage) on QTc interval was evaluated in an active-controlled (moxifloxacin 400 mg) thorough QT study. At 20-fold of glecaprevir and 5-fold of pibrentasvir therapeutic concentrations, the glecaprevir and pibrentasvir combination does not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics The pharmacokinetic properties of the components of MAVYRET in healthy subjects are provided in Table 7 . The steady-state pharmacokinetic parameters of glecaprevir and pibrentasvir in subjects with chronic HCV infection without cirrhosis are provided in Table 8 . For pellets relative to tablets in healthy adult subjects under non-fasting conditions, geometric mean ratios (GMRs) of glecaprevir and pibrentasvir C max were 0.664 and 1.137, AUC inf were 0.795 and 1.219, and C 24 (concentrations at 24 hours post-dose) were 0.917 and 1.174.

These differences were not considered clinically significant. Table 7. Pharmacokinetic Properties of the Components of MAVYRET in Healthy Subjects Glecaprevir Pibrentasvir Absorption T max (h) a of tablets 5.0

5.0T max (h) a of oral pellets 3.0

5.0Effect of meal (relative to fasting) b on tablets ↑ 83-163% ↑ 40-53% Effect of meal (relative to fasting) b on oral pellets ↑ 131-167% ↑ 56-114% Distribution % Bound to human plasma proteins 97.5 >99.9 Blood-to-plasma ratio 0.57

0.62Elimination t 1/2 (h) 6 13 Metabolism secondary, None CYP3A Major route of excretion biliary-fecal biliary-fecal % of dose excreted in urine c 0.7 0 % of dose excreted in feces c 92.1 96.6 a. Median T max following single doses of glecaprevir and pibrentasvir in healthy subjects. b. Mean systemic exposures with low/moderate to high fat meals. c.

Single dose administration of radiolabeled glecaprevir or pibrentasvir in mass balance studies. Table 8. Steady-State Pharmacokinetic Parameters of Glecaprevir and Pibrentasvir Following Administration of MAVYRET in Subjects with Chronic HCV In f ection without Cirrhosis Pharmacokinetic Parameter Glecaprevir b Pibrentasvir c C max (ng/mL) a 597 (114) 110 (49) AUC 24,ss (ng•h/mL) a 4800 (122) 1430 (57) C trough,ss (ng/mL) a 13.0 (334) 18.9 (92) a Geometric mean (%CV) of individual-estimated C max , AUC 24,ss and C trough,ss values b Relative to healthy subjects, glecaprevir C max was 51% lower, AUC 24,ss was similar (10% difference), and C trough,ss was 157% higher in subjects without cirrhosis with chronic HCV infection c Relative to healthy subjects, pibrentasvir C max was 63% lower, AUC 24,ss was 34% lower, and C trough,ss was 37% lower in subjects without cirrhosis with chronic HCV infection No clinically meaningful differences in glecaprevir and pibrentasvir exposures are expected among adult patients with acute HCV infection and adult patients with chronic HCV infection.

Specific Populations Pediatric Patients The pharmacokinetics of glecaprevir and pibrentasvir were determined in pediatric subjects with chronic HCV infection who were 3 years of age and older receiving a daily dose of MAVYRET as described below in Table 9 . GMRs of glecaprevir and pibrentasvir C max and AUC 24 in pediatrics vs. adults with chronic HCV infection ranged from 1.58-2.68 and 0.965-1.64, respectively. GMRs of glecaprevir C trough ranged from 0.292-0.954 and GMRs of pibrentasvir C trough ranged from 0.794-1.93.

All pediatric glecaprevir and pibrentasvir PK parameter values fell within the range observed in adult subjects. These differences were not considered clinically significant. No clinically meaningful differences in glecaprevir and pibrentasvir exposures are… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 33 words ▾

12.1Mechanism of Action Mechanism of Action MAVYRET is a fixed-dose combination of glecaprevir and pibrentasvir, which are direct-acting antiviral agents against the hepatitis C virus [see Microbiology ( 12.4 ) ] .

📦 How Supplied / Storage and Handling 125 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING MAVYRET Tablets Configuration Content Package Size NDC Monthly carton (blister pack) 4 weekly cartons 7 daily blisters/carton 3 tablets/blister 84 tablets 0074-2625-04 Monthly carton (wallet) 4 weekly cartons 7 daily wallets/carton 3 tablets/wallet 84 tablets 0074-2625-28 8-Week Carton 2 monthly cartons 4 weekly cartons/monthly carton 7 daily wallets/carton 3 tablets/wallet 168 tablets 0074-2625-56 Bottle 84 tablets 0074-2625-84 MAVYRET tablets are pink-colored, film-coated, oblong biconvex shaped, debossed with “NXT” on one side.

Store at or below 30°C (86°F). MAVYRET Oral Pellets MAVYRET oral pellets are dispensed in child-resistant unit-dose packets in cartons. Each carton contains 28 packets.

Each packet contains 50 mg glecaprevir/20 mg pibrentasvir pink and yellow oral pellets. The NDC number is 0074-2600-28. Store at or below 30°C (86°F).

📋 Description ~2 min read ▾

11 DESCRIPTION MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral administration. Glecaprevir/Pibrentasvir Film-Coated Immediate Release Tablets Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.

Glecaprevir and pibrentasvir are presented as a co-formulated, fixed-dose combination, immediate release bilayer tablet. The tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten.

Glecaprevir/Pibrentasvir Coated Oral Pellets MAVYRET oral pellets are small, pink and yellow and supplied in unit-dose packets for oral administration. Each unit-dose of MAVYRET oral pellets in packets contains 50 mg glecaprevir and 20 mg pibrentasvir and the following inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol/macrogol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, vitamin E (tocopherol) polyethylene glycol succinate.

The oral pellets do not contain gluten. Glecaprevir drug substance: The chemical name of glecaprevir is (3a R ,7 S ,10 S ,12 R ,21 E ,24a R )-7- tert -butyl- N -{(1 R ,2 R )-2-(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1 H ,10 H -9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12- b ]quinoxaline-10-carboxamide hydrate. The molecular formula is C 38 H 46 F 4 N 6 O 9 S (anhydrate) and the molecular weight for the drug substance is 838.87 g/mol (anhydrate).

The strength of glecaprevir is based on anhydrous glecaprevir. Glecaprevir is a white to off-white crystalline powder with a solubility of less than 0.1 to 0.3 mg/mL across a pH range of 2–7 at 37°C and is practically insoluble in water, but is sparingly soluble in ethanol. Glecaprevir has the following molecular structure: Pibrentasvir drug substance: The chemical name of pibrentasvir is Methyl {(2 S ,3 R )-1-[(2 S )-2-{5-[(2 R ,5 R )-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2 S )-1-[ N -(methoxycarbonyl)- O -methyl-L-threonyl]pyrrolidin-2-yl}-1 H -benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1 H -benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-2-yl}carbamate.

The molecular formula is C 57 H 65 F 5 N 10 O 8 and the molecular weight for the drug substance is 1113.18 g/mol. Pibrentasvir is a white to off-white to light yellow crystalline powder with a solubility of less than 0.1 mg/mL across a pH range of 1–7 at 37°C and is practically insoluble in water, but is freely soluble in ethanol. Pibrentasvir has the following molecular structure: Glecaprevir Pibrentasvir

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). 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 hepatitis B virus infection [see Warnings and Precautions ( 5.1 ) ] .

Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease Advise patients to seek medical evaluation immediately for symptoms of worsening liver problems such as nausea, tiredness, yellowing of the skin or white part of the eyes, bleeding or bruising more easily than normal, confusion, loss of appetite, diarrhea, dark or brown urine, dark or bloody stool, swelling of the stomach area (abdomen) or pain in the upper right side of the stomach area, sleepiness, or vomiting of blood [see Warnings and Precautions ( 5.2 )] .

Drug Interactions Inform patients that MAVYRET may interact with some drugs; therefore, patients should be advised to report to their healthcare provider the use of any prescription, non-prescription medication or herbal products [see Contraindications ( 4 ) , Warnings and Precautions ( 5.3 ) and Drug Interactions ( 7 ) ] . Administration For MAVYRET oral pellets, advise patients or caregivers to read and follow the Instructions for Use for preparing the correct dose [see Dosage and Administration ( 2.4 , 2.5 )] . Inform patients it is important to take all three tablets at the same time once daily with food as directed.

Inform patients that it is important not to miss or skip doses and to take MAVYRET for the duration that is recommended by the physician [see Dosage and Administration ( 2.2 ) ] . If a dose is missed and it is: Less than 18 hours from the usual time that MAVYRET should have been taken – advise the patient to take the dose as soon as possible and then to take the next dose at the usual time. More than 18 hours from the usual time that MAVYRET should have been taken – advise the patient not to take the missed dose and to take the next dose at the usual time.

Manufactured by AbbVie Inc., North Chicago, IL 60064 MAVYRET and its design are trademarks of AbbVie Inc. © 2025 AbbVie Inc. All rights reserved. 20092779

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetic properties of the components of MAVYRET in healthy subjects are provided in Table 7 . The steady-state pharmacokinetic parameters of glecaprevir and pibrentasvir in subjects with chronic HCV infection without cirrhosis are provided in Table 8 . For pellets relative to tablets in healthy adult subjects under non-fasting conditions, geometric mean ratios (GMRs) of glecaprevir and pibrentasvir C max were 0.664 and 1.137, AUC inf were 0.795 and 1.219, and C 24 (concentrations at 24 hours post-dose) were 0.917 and 1.174.

These differences were not considered clinically significant. Table 7. Pharmacokinetic Properties of the Components of MAVYRET in Healthy Subjects Glecaprevir Pibrentasvir Absorption T max (h) a of tablets 5.0

5.0T max (h) a of oral pellets 3.0

5.0Effect of meal (relative to fasting) b on tablets ↑ 83-163% ↑ 40-53% Effect of meal (relative to fasting) b on oral pellets ↑ 131-167% ↑ 56-114% Distribution % Bound to human plasma proteins 97.5 >99.9 Blood-to-plasma ratio 0.57

0.62Elimination t 1/2 (h) 6 13 Metabolism secondary, None CYP3A Major route of excretion biliary-fecal biliary-fecal % of dose excreted in urine c 0.7 0 % of dose excreted in feces c 92.1 96.6 a. Median T max following single doses of glecaprevir and pibrentasvir in healthy subjects. b. Mean systemic exposures with low/moderate to high fat meals. c.

Single dose administration of radiolabeled glecaprevir or pibrentasvir in mass balance studies. Table 8. Steady-State Pharmacokinetic Parameters of Glecaprevir and Pibrentasvir Following Administration of MAVYRET in Subjects with Chronic HCV In f ection without Cirrhosis Pharmacokinetic Parameter Glecaprevir b Pibrentasvir c C max (ng/mL) a 597 (114) 110 (49) AUC 24,ss (ng•h/mL) a 4800 (122) 1430 (57) C trough,ss (ng/mL) a 13.0 (334) 18.9 (92) a Geometric mean (%CV) of individual-estimated C max , AUC 24,ss and C trough,ss values b Relative to healthy subjects, glecaprevir C max was 51% lower, AUC 24,ss was similar (10% difference), and C trough,ss was 157% higher in subjects without cirrhosis with chronic HCV infection c Relative to healthy subjects, pibrentasvir C max was 63% lower, AUC 24,ss was 34% lower, and C trough,ss was 37% lower in subjects without cirrhosis with chronic HCV infection No clinically meaningful differences in glecaprevir and pibrentasvir exposures are expected among adult patients with acute HCV infection and adult patients with chronic HCV infection.

Specific Populations Pediatric Patients The pharmacokinetics of glecaprevir and pibrentasvir were determined in pediatric subjects with chronic HCV infection who were 3 years of age and older receiving a daily dose of MAVYRET as described below in Table 9 . GMRs of glecaprevir and pibrentasvir C max and AUC 24 in pediatrics vs. adults with chronic HCV infection ranged from 1.58-2.68 and 0.965-1.64, respectively. GMRs of glecaprevir C trough ranged from 0.292-0.954 and GMRs of pibrentasvir C trough ranged from 0.794-1.93.

All pediatric glecaprevir and pibrentasvir PK parameter values fell within the range observed in adult subjects. These differences were not considered clinically significant. No clinically meaningful differences in glecaprevir and pibrentasvir exposures are expected among pediatric patients with acute HCV infection and pediatric patients with chronic HCV infection.

The pharmacokinetics of glecaprevir and pibrentasvir have not been established in children less than 3 years of age. Table 9. Pharmacokinetic Parameters of Glecaprevir (GLE) and Pibrentasvir (PIB) in Pediatric Subjects with Chronic HCV Infection Age and Weight (kg) N Total Daily Dose of GLE/PIB (mg) PK Parameter Geometric Mean (%CV) GLE PIB 12 to < 18 years, ≥ 45 kg 14 300/120 AUC 24 (ng•h/mL) 4790 (72) 1380 (40) C max (ng/mL) 1040 (86) 174 (36) C trough (ng/mL) 3.79 (82) 15.0 (61) 9 to < 12 years, 30 to < 45 kg 13 250/100 AUC 24 (ng•h/mL) 7870 (209) 2200 (99) C max (ng/mL) 1370 (169) 225 (72) C trough (ng/mL… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 70 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology The effect of doses up to glecaprevir 600 mg (2 times the recommended dosage) with doses up to pibrentasvir 240 mg (2 times the recommended dosage) on QTc interval was evaluated in an active-controlled (moxifloxacin 400 mg) thorough QT study. At 20-fold of glecaprevir and 5-fold of pibrentasvir therapeutic concentrations, the glecaprevir and pibrentasvir combination does not prolong the QTc interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Description of Clinical Trials Table 12 summarizes the clinical trials conducted to support the effectiveness of MAVYRET in subjects with HCV genotype 1, 2, 3, 4, 5 or 6 infection and compensated liver disease (including Child-Pugh A cirrhosis) according to treatment history and cirrhosis status. Table 12. Clinical Trials Conducted with MAVYRET in Subjects with HCV Genotype 1, 2, 3, 4, 5 or 6 Infection and Compensated Liver Disease Genotype (GT) Clinical Trial (NCT Number) Treatment Duration* Clinical Trials of Chronic HCV Infection TN and PRS-TE Subjects without Cirrhosis GT1** ENDURANCE-1 (NCT02604017) MAVYRET for 8 (n=351) or 12 weeks (n=352) GT2 SURVEYOR-2 (NCT02243293) MAVYRET for 8 weeks (n=197) GT3 ENDURANCE-3 (NCT02640157) MAVYRET for 8 (n=157) or 12 weeks (n=233) sofosbuvir + daclatasvir for 12 weeks (n=115) SURVEYOR-2 MAVYRET for 16 (PRS-TE only) weeks (n=22) GT4, 5, 6 ENDURANCE-5,6 (NCT02966795) MAVYRET for 8 weeks (GT5 n=20; GT6 n=55) SURVEYOR-2 MAVYRET for 8 weeks (GT4 n=46; GT5 n=2; GT6 n=10) GT1, 2, 3, 6 VOYAGE-1 (NCT03222583) MAVYRET for 8 (n=356) or 16 weeks (n=6; GT3 PRS-TE only) TN and PRS-TE Subjects with Compensated Cirrhosis GT1, 2, 4, 5, 6 EXPEDITION-1 (NCT02642432) MAVYRET for 12 weeks (n=146) GT1, 2, 3, 4, 5, 6 EXPEDITION-8 (NCT03089944) MAVYRET for 8 weeks (n=343) (TN only) GT3 SURVEYOR-2 MAVYRET for 16 weeks (PRS-TE only) (n=47) GT5, 6 ENDURANCE-5,6 MAVYRET for 12 weeks (GT 5 n=3; GT 6 n=6) GT1, 2, 3, 4, 6 VOYAGE-2 (NCT03235349) MAVYRET for 12 (n=157) or 16 weeks (n=3; GT3 PRS-TE only) Subjects with CKD Stage 4 and 5 without Cirrhosis or with Compensated Cirrhosis GT1-6 EXPEDITION-4 (NCT02651194) MAVYRET for 12 weeks (n=104) NS5A Inhibitor or PI-Experienced Subjects without Cirrhosis or with Compensated Cirrhosis GT1 MAGELLAN-1 (NCT02446717) MAVYRET for 12 (n=25) or 16 weeks (n=17) HCV/HIV-1 Co-Infected Subjects without Cirrhosis or with Compensated Cirrhosis GT1, 2, 3, 4, 6 EXPEDITION-2 (NCT02738138) MAVYRET for 8 (n=137) or 12 weeks (n=16) Liver or Kidney Transplant Recipients without Cirrhosis GT1, 2, 3, 4, 6 MAGELLAN-2 (NCT02692703) MAVYRET for 12 weeks (n=100) Adolescent Subjects (12 to less than 18 years) GT1, 2, 3, 4** DORA (Part 1) (NCT03067129) MAVYRET for 8 (n=44) or 16 weeks (n=3) Pediatric Subjects (3 to less than 12 years) GT1, 2, 3, 4** DORA (Part 2) (NCT03067129) MAVYRET for 8 (n=78), 12 (n=1), or 16 weeks (n=1) Clinical Trial of Acute HCV Infection GT1, 2, 3, 4** M20-350 (NCT04903626) MAVYRET for 8 weeks (n=286) TN=treatment naïve; PI=protease inhibitor; CKD=chronic kidney disease PRS-TE= defined as prior treatment experience with regimens containing (peg)interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor. * Treatment durations for some trial arms shown in this table do not reflect recommended dosing for the respective genotypes, prior treatment history, and/or cirrhosis status.

For recommended dosing in adults and pediatric patients 3 years and older [see Dosage and Administration ( 2.2 , 2.3 , 2.4 ) ] . ** ENDURANCE-1 included 33 subjects co-infected with HIV-1. DORA included 3 subjects co-infected with HIV-1. M20-350 included 142 subjects co-infected with HIV-1.

Serum HCV RNA values were measured during the clinical trials using the Roche COBAS AmpliPrep/COBAS TaqMan HCV test (version 2.0) with a lower limit of quantification (LLOQ) of 15 IU/mL (except for SURVEYOR-2 which used the Roche COBAS TaqMan real-time reverse transcriptase-PCR (RT-PCR) assay v. 2.0 with an LLOQ of 25 IU/mL). The primary endpoint across all clinical trials was sustained virologic response (SVR12), defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment.

Relapse was defined as HCV RNA ≥ LLOQ after end-of-treatment response among subjects who completed treatment. Subjects with missing HCV RNA data, such as those who discontinued due to an adverse event, subject withdrawal or were lost to follow-up, were… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 104 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis Glecaprevir and pibrentasvir were 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 rodent micronucleus assays. Carcinogenicity studies with glecaprevir and pibrentasvir have not been conducted. Impairment of Fertility No effects on mating, female or male fertility, or early embryonic development were observed in rodents at up to the highest dose tested.

Systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 63 and 102 times higher, respectively, than the exposure in humans at the recommended dose.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 101 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis Glecaprevir and pibrentasvir were 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 rodent micronucleus assays. Carcinogenicity studies with glecaprevir and pibrentasvir have not been conducted. Impairment of Fertility No effects on mating, female or male fertility, or early embryonic development were observed in rodents at up to the highest dose tested.

Systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 63 and 102 times higher, respectively, than the exposure in humans at the recommended dose.

📄 Patient Package Insert ~3 min read ▾

Patient Information MAVYRET ® (MAV-ih-reht) (glecaprevir and pibrentasvir) tablets MAVYRET ® (MAV-ih-reht) (glecaprevir and pibrentasvir) oral pellets What is the most important information I should know about MAVYRET? MAVYRET can cause serious side effects, including: Hepatitis B virus reactivation. Before starting treatment with MAVYRET, 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 for hepatitis C virus with MAVYRET. Hepatitis B virus that becomes 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 MAVYRET.

For more information about side effects, see the section “What are the possible side effects of MAVYRET?” What is MAVYRET? MAVYRET is a prescription medicine used to treat adults and children 3 years of age and older with: acute (recently infected) or chronic (lasting a long time) hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis. HCV genotype 1 infection who have been previously treated with a regimen that contained an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

MAVYRET contains the 2 medicines: glecaprevir and pibrentasvir. It is not known if MAVYRET is safe and effective in children under 3 years of age. Do not take MAVYRET if you : have certain liver problems also take any of the following medicines: ○ atazanavir ○ rifampin Before taking MAVYRET, tell your healthcare provider about all of your medical conditions, including if you: have had hepatitis B virus infection have liver problems other than hepatitis C virus infection have HIV-1 infection have had a liver or a kidney transplant are pregnant or plan to become pregnant.

It is not known if MAVYRET will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if MAVYRET passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with MAVYRET.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. MAVYRET and other medicines may affect each other. This can cause you to have too much or not enough MAVYRET or other medicines in your body.

This may affect the way MAVYRET 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 MAVYRET.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take MAVYRET with other medicines. How should I take MAVYRET?

Take MAVYRET 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 MAVYRET without first talking with your healthcare provider.

Do not miss or skip doses of MAVYRET during treatment. Take MAVYRET with food. For adults, adolescents 12 years and older, or children weighing at least 99 pounds (45 kg), the usual dose of MAVYRET is 3 tablets at the same time each day.

For children 3 years to less than 12 years of age and weighing less than 99 pounds (45 kg), your child’s healthcare provider will prescribe the right dose of MAVYRET oral pellets based on your child’s body weight. If your child’s healthcare provider prescribes MAVYRET oral pellets for your child, see “ How should I give MAVYRET oral pellets to my child ?” If you miss a dose of MAVYRET and it is: Less than 18 hours from the time you usually take MAVYRET, take the missed dose with food as soon as possible. Then take you… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use 19 words ▾

INSTRUCTIONS FOR USE MAVYRET ® (MAV-ih-reht) (glecaprevir and pibrentasvir) pellets for oral use INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE

📄 Recent Major Changes 14 words ▾

Indications and Usage ( 1 ) 6/2025 Dosage and Administration ( 2.2 ) 6/2025

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL NDC 0074-2625-04 Rx only MAVYRET ® (glecaprevir and pibrentasvir) 100mg / 40mg Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg. This carton contains 21 tablets packaged as follows: 7 daily blisters for 1 week of treatment. Each daily blister contains 3 tablets.

MON TUE WED THU FRI SAT SUN Track your daily treatment by pushing in the tab above after removing each pack from carton. NDC 0074-2625-04 Rx only MAVYRET® (glecaprevir and pibrentasvir) 100mg / 40mg Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg. This carton contains 21 tablets packaged as follows: 7 daily blisters for 1 week of treatment.

Each daily blister contains 3 tablets. MON TUE WED THU FRI SAT SUN Track your daily treatment by pushing in the tab above after removing each pack from carton.

PRINCIPAL DISPLAY PANEL NDC 0074-2625-04 4-WEEK SUPPLY Rx only M AVYRET ® (glecaprevir and pibrentasvir) 100mg / 40mg Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg. This monthly carton contains 84 tablets packaged as follows: 4 weekly cartons of therapy. Each weekly carton contains 21 tablets in 7 daily blisters of 3 tablets each.

NDC 0074-2625-04 4-WEEK SUPPLY Rx only MAVYRET® (glecaprevir and pibrentasvir) 100mg / 40mg Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg. This monthly carton contains 84 tablets packaged as follows: 4 weekly cartons of therapy. Each weekly carton contains 21 tablets in 7 daily blisters of 3 tablets each.

PRINCIPAL DISPLAY PANEL NDC 0074-2625-28 Rx only M avyret ® (glecaprevir and pibrentasvir) 100mg / 40mg Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg. This carton contains 21 tablets packaged as follows: 7 wallets for 1 week of treatment. Each wallet contains 3 tablets.

MON TUE WED THU FRI SAT SUN Track your daily treatment by pushing in the tab above after removing each pack from carton. NDC 0074-2625-28 Rx only Mavyret® (glecaprevir and pibrentasvir) 100mg / 40mg Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg. This carton contains 21 tablets packaged as follows: 7 wallets for 1 week of treatment.

Each wallet contains 3 tablets. MON TUE WED THU FRI SAT SUN Track your daily treatment by pushing in the tab above after removing each pack from carton.

PRINCIPAL DISPLAY PANEL NDC 0074-2625-28 Rx only 4-WEEK SUPPLY Mavyret ® (glecaprevir and pibrentasvir) 100mg / 40mg Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg This monthly carton contains 84 tablets packaged as follows: 4 weekly cartons of therapy. Each weekly carton contains 21 tablets in 7 wallets of 3 tablets each. NDC 0074-2625-28 Rx only 4-WEEK SUPPLY Mavyret® (glecaprevir and pibrentasvir) 100mg / 40mg Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg This monthly carton contains 84 tablets packaged as follows: 4 weekly cartons of therapy.

Each weekly carton contains 21 tablets in 7 wallets of 3 tablets each.

PRINCIPAL DISPLAY PANEL NDC 0074-2600-28 Rx only MAVYRET ® (glecaprevir/pibrentasivir) Oral Pellets 50 mg/20 mg Each packet contains pink and yellow oral pellets. 28 packets PRINCIPAL DISPLAY PANEL NDC 0074-2600-28 Rx only MAVYRET® (glecaprevir/pibrentasivir) Oral Pellets 50 mg/20 mg Each packet contains pink and yellow oral pellets. 28 packets

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
28
Units reimbursed last 4 qtrs
2.7K
Gross reimbursed last 4 qtrs
$240.4K
Avg / prescription
$8,585.54
Avg / unit
$88.5108
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 28 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 2,716 units · 12.0 per 100k residents FL
Units reimbursed · per 100k residents
12.012.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Florida 12.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Mavyret — 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 Mavyret. 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
$49.46M
Claims incl. refills
3.7K
Beneficiaries
2.5K
Spend / beneficiary
$19,682.88
Spend / claim
$13,200.71
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.

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) ✓ Available
“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 AbbVie Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AbbVie 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.
← 00074-2585-99 · AbbVie 00074-2625-01 · AbbVie →
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.