News

NORTH CHICAGO, Ill., Oct. 11, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced that it will present new data evaluating MAVYRET™ (glecaprevir/pibrentasvir), its once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6), at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). Sixteen AbbVie scientific abstracts have been accepted, including two oral presentations studying the use of MAVYRET in patients across genotypes (GT1-6) with compensated cirrhosis and treatment-naïve patients with genotype 3 (GT3) HCV. These populations have historically had limited treatment options. A third oral presentation evaluates adherence to treatment with MAVYRET in the clinical development program. The Liver Meeting® 2017 will take place in Washington, D.C., from October 20 – 24, 2017.

"AbbVie's data presentations at this year's The Liver Meeting reinforce our commitment to people living with hepatitis C," said Janet Hammond, M.D., Ph.D., vice president, infectious diseases development, AbbVie. "These data add to a robust collection of clinical trial results to further enhance scientific knowledge of MAVYRET's safety and efficacy across a number of patient populations."

Researchers will also present data obtained from the MAVYRET clinical program evaluating patients with cardiovascular, metabolic and renal conditions as well as data on HCV patient preferences.

"On the heels of AASLD's newly released HCV treatment guidance, we are excited to see additional data on MAVYRET across a broad range of patients," said Fred Poordad, M.D., vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. "The updated recommendations on available treatments, including the use of MAVYRET in the majority of patients, serve as an additional source of information to help physicians make treatment decisions."

Select AbbVie clinical presentations include:

MAVYRET Abstracts

• Adherence to Pangenotypic Glecaprevir/Pibrentasvir Treatment and SVR₁₂ in HCV-Infected Patients: An Integrated Analysis of the Phase 2/3 Clinical Trial Program - Abstract 198; Oral Presentation; Monday, October 23, 2017; 4:15 p.m. ET
• Efficacy and Safety of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Treatment-Naïve Patients with Chronic HCV Genotype 3: An Integrated Phase 2/3 Analysis - Abstract 62; Oral Presentation; Sunday, October 22, 2017; 1:15 p.m. ET
• Efficacy, Safety, and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis - Abstract 74; Oral Presentation; Sunday, October 22, 2017; 3:15 p.m. ET
• Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Infected with HCV GT1-3 by Renal Impairment Status: A Pooled Analysis of Two Phase 3 Japanese Trials - Abstract 1179; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
• Safety and Efficacy of Glecaprevir/Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1–6 and Recent Drug Use - Abstract 1182; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
• Safety and Efficacy of Glecaprevir/Pibrentasvir in Patients Aged 65 Years or Older With Chronic Hepatitis C: A Pooled Analysis of Phase 2 and 3 Clinical Trials - Abstract 1188; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
• Impact of Hepatitis C Treatment With Glecaprevir + Pibrentasvir on Patient`s Health-Related Quality of Life: Results From Phase 3 CERTAIN Trials - Abstract 1187; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
• Exposure-Safety Response Relationship for Glecaprevir and Pibrentasvir in Hepatitis C Virus-Infected Subjects in Phase 2 and 3 Studies - Abstract 1189; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
• Exposure-Response Analyses of Virologic Response to Glecaprevir and Pibrentasvir in HCV Subjects from Phase 2 and 3 Studies - Abstract 1185; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
• Glecaprevir and Pibrentasvir Exposures in Hepatitis C Virus-Infected Subjects in Phase 2 and 3 Studies - Abstract 1190; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET

HCV Health Outcomes Abstract

• Assessing Patient Preferences for and Relative Importance of Features of New Direct Acting Antiviral (DAA) Treatments for Chronic Hepatitis C Virus (HCV) Infections - Abstract 741; Poster Session; Friday, October 20, 2017; 8:00 a.m. – 5:30 p.m. ET

The full AASLD 2017 scientific program can be found at www.aasld.org.

About MAVYRET™ (glecaprevir/pibrentasvir) 
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 once-daily as three oral tablets, taken with food.

MAVYRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment, 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 Information

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 reactivation: Before starting treatment with MAVYRET, a doctor will do blood tests to check for hepatitis B virus infection. If people have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with MAVYRET. Hepatitis B virus becoming 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 hepatitis B virus 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 (Evotaz^®, Reyataz^®)
  • rifampin (Rifadin^®, Rifamate^®, Rifater^®, Rimactane^®)

What should people tell a doctor before taking MAVYRET?

• If they have ever had hepatitis B virus infection, liver problems other than hep C infection, or any 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 common side effects of MAVYRET?

• 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 www.pparx.org for assistance.

About AbbVie
AbbVie is a global, research-driven 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 or LinkedIn.

Forward-Looking Statements
Some statements in this news release may be 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," in AbbVie's 2015 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