AbbVie Receives FDA Approval of MAVYRET® (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes

NORTH CHICAGO, Ill., Sept. 26, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of MAVYRET^® (glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes (GT1-6). In August 2017, MAVYRET received regulatory approval in the U.S. as an 8-week, pan-genotypic treatment for treatment-naïve HCV patients without cirrhosis.

"While over 100,000 patients have been prescribed MAVYRET for chronic HCV in the US^?, there are still a significant number of patients that need options," said Janet Hammond, M.D., Ph.D., vice president, general medicine and virology therapeutic area, AbbVie. "This approval provides more HCV patients an option to treat their disease in as little as 8 weeks."

The label expansion was based on data from the Phase 3b EXPEDITION-8 study, a single-arm, open-label study evaluating the safety and efficacy of MAVYRET in treatment-naïve adults with GT1-6 chronic HCV and compensated cirrhosis. In the study, an overall 98 percent (n=335/343) of patients achieved a sustained virologic response 12 weeks after treatment (SVR₁₂).¹

"With more than 2.3 million people in the United States still living with chronic HCV, access to shorter-term, 8-week treatment options can help us move closer to achieving the World Health Organization's goal of eliminating HCV by 2030," said Robert S. Brown, Jr., M.D., Gladys and Roland Harriman professor of medicine, Weill Cornell Medical College.

In EXPEDITION-8, a single relapse out of 336 patients treated was reported and no patients discontinued treatment due to adverse events.^1,2 The adverse reactions reported in greater than or equal to 5 percent of compensated cirrhotic patients (n=343) were fatigue (8%), pruritus (7%), and headache (6%).¹ Data from cohort one (GT1,2,4,5,6) was presented last year at The Liver Meeting^® 2018 organized by the American Association for the Study of Liver Diseases (AASLD), and data from cohort two (GT3) will be presented at an upcoming medical meeting.

About the EXPEDITION-8 Study^1,2
EXPEDITION-8 is a single-arm, open-label, Phase 3b study in treatment-naïve, 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-naïve 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-naïve 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

What should people tell a doctor before taking MAVYRET?

• 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.

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. 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.

These are not all of the possible side effects of MAVYRET. A doctor should be notified if there is any side effect that is bothersome or that does not go away.

This is the most important information to know about MAVYRET. For more information, people should talk to a doctor or healthcare provider.

People 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 people cannot afford their medication, they should contact AbbVie.com/myAbbVieAssist to learn more.

About AbbVie 

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

For more information, please visit www.abbvie.com/HCV.

Forward-Looking Statements 

Some 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, among others, 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 indicated 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, and changes to laws and regulations applicable to our industry.

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 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

SOURCE AbbVie