AbbVie Receives FDA Approval of MAVYRET? (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Na?ve Patients with Chronic Hepatitis C and Compensated Cirrhosi
- FDA approval is supported by an overall 98 percent cure** rate across this patient population[1]
EXPEDITION-8 is a single-arm, open-label, Phase?3b?study in treatment-na?ve, GT1-6 chronic HCV patients with compensated cirrhosis (n=343) who received MAVYRET for 8 weeks. The primary endpoints are the sustained virologic response 12 weeks after treatment (SVR12) rates in patients across all genotypes in a per-protocol (PP) and intent-to-treat (ITT) population versus respective historical SVR12?rates based on the efficacy of MAVYRET for 12 weeks in treatment-na?ve patients with compensated cirrhosis. The key secondary efficacy endpoints are the percentages of GT1- 6 patients achieving SVR12?in a PP and ITT population. Additional information on the clinical trials for MAVYRET is available at?www.clinicaltrials.gov/. About MAVYRET??(glecaprevir/pibrentasvir)1
MAVYRET??is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVYRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed as three tablets taken at the same time once daily with food. MAVYRET is an 8-week, pan-genotypic option for treatment-na?ve patients without cirrhosis or with compensated cirrhosis, who comprise the majority of people living with HCV. MAVYRET is also approved as a treatment for patients with specific treatment challenges, including those (GT1) not cured by prior treatment experience to either a protease inhibitor or NS5A inhibitor (but not both), and in patients with limited treatment options, such as those with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is a pan-genotypic treatment approved for use in patients across all stages of CKD. Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Full prescribing information can be found?here. Use and Important Safety Information1 USE? MAVYRET??(glecaprevir and pibrentasvir) tablets are a prescription medicine used to treat adults with 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. IMPORTANT SAFETY INFORMATION What is the most important information to know about MAVYRET??
Hepatitis B virus (hep B) reactivation:?Before starting treatment with MAVYRET, a doctor will do blood tests to check for hep B infection. If people 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. A doctor will monitor people if they are at risk for hep B reactivation during treatment and after they stop taking MAVYRET. MAVYRET must not be taken if people:
- Have certain liver problems
- Are taking the medicines atazanavir or rifampin
- If they 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 they are pregnant or plan to become pregnant, or if they are breastfeeding or plan to breastfeed. It is not known if MAVYRET will harm a person's unborn baby or pass into breast milk. A doctor should be consulted about the best way to feed a baby if taking MAVYRET.
- About all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. MAVYRET and other medicines may affect each other. This can cause people to have too much or not enough MAVYRET or other medicines in their body. This may affect the way MAVYRET or other medicines work or may cause side effects.
- A new medicine must not be started without telling a doctor.?A doctor will provide instruction on whether 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.?Their doctor will check them for signs and symptoms of worsening liver problems during treatment with MAVYRET. They should tell their doctor right away if they have any of the following: nausea; tiredness; yellowing of the skin or white part of the 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 the stomach area (abdomen); sleepiness; vomiting of blood; or lightheadedness.
- The most common side effects of MAVYRET are headache and tiredness.
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*Refers to patients with Child-Pugh A cirrhosis score. |
?Liver or kidney transplant recipients are not eligible for an 8-week regimen. |
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR) are considered cured of hepatitis C.? |
?Based on retail and non-retail prescription data from IQVIA week ending 8/11/17-8/2/19.3 |
1MAVYRET??tablets (glecaprevir/pibrentasvir) Prescribing Information. Chicago, U.S. AbbVie Inc.? |
2?Brown RS, Hezode C, Wang S, et al. Preliminary Efficacy and Safety of 8-Week Glecaprevir/Pibrentasvir in Patients with HCV Genotype 1?6 Infection and Compensated Cirrhosis: The EXPEDITION-8 Study.?Presented at The Liver Meeting?, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, U.S., November 13, 2018. |
3?Data on file. AbbVie Inc. IQVIA. National Prescription Audit (NPA) week ending 8/11/2017 to week ending 8/2/2019, Weekly Sales Perspective (WSP) and Longitudinal Prescription Claims (LRx) week ending 8/4/2017 to week ending 7/26/2019. August 2019. (IQVIA, all rights reserved). |
Contact(s)
Media Raquel Powers +1 (847) 935-6563 raquel.powers@abbvie.com or Investor Relations Liz Shea +1 (847) 935-2211
liz.shea@abbvie.com