U.S. FDA Approves Expanded Indication for AbbVie's Mavyret (Glecaprevir/Pibrentasvir) as First and Only Treatment for People with Acute Hepatitis C Virus

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NORTH CHICAGO, Ill., June 11, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, Mavyret is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate. 2,†

HCV is a highly infectious blood-borne disease affecting the liver.1 People recently infected, or those with acute HCV, may not have symptoms.1 If left untreated, HCV could lead to liver-related complications, such as cirrhosis or liver cancer.1 The United States is expected to incur ~$120 billion in total medical costs over the next 10 years through 2035 linked to chronic liver disease and other related conditions caused by untreated HCV.3

"The physical, emotional, and economic burden of a curable condition like hepatitis C is far too great in the United States and around the world," said John Ward, M.D., director, Coalition for Global Hepatitis Elimination. "If treated early with safe and effective therapies, providers can cure virtually all patients with hepatitis C before it escalates to chronic disease and eventually cirrhosis or liver cancer. The public health community now has a good opportunity to cure nearly all persons to support eliminating the toll of this deadly virus. No one should die of hepatitis C."

Current global clinical guidance calls for the universal treatment of nearly all people with acute or chronic HCV infection.4 Widespread implementation of these guidelines has the potential to substantially reduce the global spread of the disease.4 Additionally, the public health community has set a goal to eliminate HCV by 2030.5 Nearly 80% of high-income countries, including the U.S., are not on track to achieve this goal until after 2050.5,6

"Mavyret has treated more than one million patients with HCV, but we recognize that a significant need remains for patients with acute infection," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "The label expansion for Mavyret, coupled with the implementation of test and treat models of care, serve as tools to support the public health community in treating more patients and bringing us closer to achieving the global 2030 elimination goal."

The FDA granted Breakthrough Therapy Designation (BTD) for Mavyret for the treatment of acute HCV. The BTD program is designed to expedite the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.7

The label expansion was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of Mavyret eight-week treatment in adults with acute HCV infection.2 The study results showed Mavyret to be a highly efficacious treatment for people with acute HCV.2 The majority of the adverse events reported were mild or moderate in severity.2 The most common adverse events were fatigue, asthenia, headache, and diarrhea.2

About the Phase 3 M20-350 Study8The multicenter, single-arm prospective Phase 3 M20-350 clinical trial was designed to evaluate the safety and efficacy of Mavyret (glecaprevir/pibrentasvir) eight-week treatment in adults and pediatric patients with acute HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally. Patients received oral tablets of Mavyret once daily for eight weeks and were followed for 12 weeks after the end of treatment. The primary endpoint was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR12) in the Intention-to-Treat (ITT) population. Secondary endpoints included the percentage of patients achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) population, and the percentage of patients with on-treatment virologic failure and post-treatment relapse in the ITT population. More information on the study can be found on www.clinicaltrials.gov (NCT04903626).

*For treatment-naïve non-cirrhotic and compensated cirrhotic patients. Liver or kidney transplant recipients are not eligible for an 8-week regimen.

†Cure rate = sustained virologic response (SVR12); HCV RNA less than the lower limit of quantification at 12 weeks after the end of treatment.

About Mavyret® (glecaprevir/pibrentasvir)

USE

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 (hep C) genotypes 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis.
  • Hep C genotype 1 infection who have been previously treated with a regimen that contained a hep C NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

    • IMPORTANT SAFETY INFORMATION

    What is the most important information I should know about Mavyret?

    Hepatitis B virus (hep B) reactivation: Before starting treatment with Mavyret, your doctor will do blood tests to check for hep B infection. If you have ever had hep B infection, hep B could become active again during or after treatment for hep C with Mavyret. Hep B that becomes active again (called reactivation) may cause serious liver problems, including liver failure and death. Your doctor will monitor you if you are at risk for hep B reactivation during treatment and after you stop taking Mavyret.

    Do not take Mavyret if you:

  • Have moderate or severe liver impairment (Child-Pugh B or C) or any history of prior liver decompensation
  • Are taking the medicines atazanavir or rifampin

    • What should I tell my doctor before taking Mavyret?

  • If you have had hep B infection, have liver problems other than hep C infection, have HIV-1 infection, have had a liver or a kidney transplant, and all other medical conditions.
  • If you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. It is not known if Mavyret will harm your unborn baby or pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take Mavyret.
  • 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.
  • Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take Mavyret with other medicines.

    • What are the possible side effects of Mavyret?

  • In people who had or have advanced liver problems before starting treatment with Mavyret, there is a rare risk of worsening liver problems, liver failure, and death. Your doctor will check you for signs and symptoms of worsening liver problems during treatment with Mavyret. Tell your doctor right away if you have any of the following: nausea; tiredness; yellowing of your skin or white part of your eyes; bleeding or bruising more easily than normal; confusion; dark, black, or bloody stool; loss of appetite; diarrhea; dark or brown (tea-colored) urine; swelling or pain on the upper right side of your stomach area (abdomen); sleepiness; vomiting of blood; or lightheadedness.
  • The most common side effects of Mavyret are headache and tiredness.

    • These are not all the possible side effects of Mavyret. Call your doctor for medical advice about side effects.

    This is the most important information to know about Mavyret. For more information, talk to your doctor or healthcare provider.

    Mavyret oral pellets are dispensed in unit-dose packets. Each packet contains 50 mg glecaprevir/20 mg pibrentasvir.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    Please see full Prescribing Information, including the Patient Information.

    If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.

    About AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube.

    Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

    References

    1 Hepatitis C. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/hepatitis-c.

    2 Mavyret®. Prescribing Information. AbbVie, Inc.; 2025. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.rxabbvie.com/pdf/Mavyret_pi.pdf.

    3 AbbVie. Data on file: H25.DOF.029.

    4 Debika Bhattacharya, et al. American Association for the Study of Liver Diseases – Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection, Clinical Infectious Diseases, 2023;, ciad319.

    5 Gamkrelidze, I Pawlotsky JM, Lazarus JV, Feld JJ, Zeuzem S, Bao Y, Gabriela Pires Dos Santos A, Sanchez Gonzalez Y, Razavi H. Progress towards hepatitis C virus elimination in high-income countries: An updated analysis. Liver Int. 2021 Mar;41(3):456-463. doi: 10.1111/liv.14779. Epub 2021 Jan 19. PMID: 33389788.

    6 The CDA Foundation. Hepatitis C – [United States]. Lafayette, CO: CDA Foundation, 2025. Available at: https://cdafound.org/polaris/database-query/.

    7 U.S. Food and Drug Administration. Breakthrough Therapy. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy#:~:text=Breakthrough%20Therapy%20designation%20is%20a,clinically%20significant%20endpoint(s).

    8 A Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB). ClinicalTrials.gov identifier: NCT04903626. Available at: https://www.clinicaltrials.gov/study/NCT04903626?term=NCT04903626&rank=1.

    SOURCE AbbVie

    Posted : 2025-06-12 12:00

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