"U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET® (Glecaprevir/Pibrentasvir) as First and Only Treatment for People with Acute Hepatitis C Virus
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.
• HCV is a highly infectious blood-borne disease affecting the liver. People recently infected, or those with acute HCV, may not have symptoms.
• If left untreated, HCV could lead to liver-related complications, such as cirrhosis or liver cancer.
• 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.
• ""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.""
• MAVYRET received Breakthrough Therapy Designation (BTD) from the FDA for treating acute Hepatitis C (HCV).
• The BTD program accelerates development and review of treatments for serious conditions.
• Preliminary clinical evidence suggests MAVYRET may provide significant improvement over existing therapies.
• The designation may help fast-track approval for broader patient access.
• ""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.""
FDA Grants Breakthrough Therapy Designation for MAVYRET in Acute HCV Treatment
• MAVYRET received Breakthrough Therapy Designation (BTD) from the FDA for treating acute Hepatitis C (HCV).
• The BTD program accelerates development and review of treatments for serious conditions.
• Preliminary clinical evidence suggests MAVYRET may provide significant improvement over existing therapies.
• The designation may help fast-track approval for broader patient access.
• 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.
• The study results showed MAVYRET to be a highly efficacious treatment for people with acute HCV.
• The majority of the adverse events reported were mild or moderate in severity.
• The most common adverse events were fatigue, asthenia, headache, and diarrhea.
• The 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).
More info-
*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.
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.
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.
• 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.
• 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.
AbbVie assistance
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.
• AbbVie'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 statements include terms like believe, expect, anticipate, and project and involve future uncertainties.
AbbVie warns that actual results may differ due to risks, including:
• Intellectual property challenges & product competition.
• Research & development complexities.
• Litigation, regulatory changes, and economic downturns.
• Global factors such as trade disputes, tariffs, and international conflicts.
• Additional risks are outlined in AbbVie’s 2024 Annual Report (Form 10-K) & SEC filings.
• AbbVie is not obligated to publicly revise forward-looking statements unless required by law.
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