AbbVie Announces New Phase 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis

- 100 percent SVR(12) rate achieved with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin(1) 

Jun 24, 2015

NORTH CHICAGO, Ill., June 24, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced TURQUOISE-III study results demonstrating 100 percent (n=60/60) sustained virologic response at 12 weeks post-treatment (SVR₁₂) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis.¹ Patients received 12 weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV). These new results from AbbVie's Phase 3b study will be presented at the 15^th Annual International Symposium on Viral Hepatitis and Liver Diseases in Berlin, Germany.

Approximately 160 million people worldwide are infected with HCV.² Genotype 1 is the most common type of HCV genotype, accounting for 60 percent of cases worldwide³ and in Europe, the most prevalent genotype is 1b (47 percent).⁴ Over time, chronic HCV may lead to liver complications, including compensated cirrhosis, in about 10-20 percent of people infected.²

"Genotype 1b represents a large portion of HCV patients globally, as it is the most prevalent sub-genotype, and there is a need to continue to explore additional treatment regimens," said Jordan J. Feld, M.D., MPH, research director and clinician scientist, Toronto Center for Liver Disease, Toronto, Canada. "The results of TURQUOISE-III are promising, demonstrating that genotype 1b HCV patients with compensated liver cirrhosis have the potential to achieve high response rates with an interferon and ribavirin-free treatment in 12 weeks."

Patients in TURQUOISE-III were either treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). No patients discontinued treatment due to adverse events.¹ The most commonly reported adverse events (>10 percent) were fatigue (22 percent), diarrhea (20 percent) and headache (18 percent).¹

"In the TURQUOISE-III study, GT1b patients with compensated liver cirrhosis achieved a 100 percent cure rate with VIEKIRAX + EXVIERA without ribavirin," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "TURQUOISE-III is part of our Phase 3b program, which aims to further enhance our understanding of AbbVie's regimen in HCV populations seen in clinical practice, and supports our commitment to continued investigation in this field."

About TURQUOISE-III Study
TURQUOISE-III is a multi-center, open-label Phase 3b study to evaluate the safety and efficacy of 12 weeks of treatment with VIEKIRAX® + EXVIERA® without ribavirin (RBV) in adult patients (n=60) with genotype 1b chronic hepatitis C virus infection and compensated liver cirrhosis who were treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). The primary endpoint is the rate of sustained virologic response 12 weeks after treatment (SVR₁₂).¹

No patients experienced virologic failure during treatment and no patients experienced virologic relapse following the end of treatment.¹

About VIEKIRAX® + EXVIERA® VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.

VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.

About AbbVie's HCV Clinical Development ProgramThe AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating interferon-free, all-oral treatments with or without ribavirin with the goal of achieving high sustained virologic response rates in as many patients as possible. AbbVie's global Phase 3b program plans to include more than 2,800 genotype 1 patients in over 200 study centers worldwide, including the U.S., Canada, Europe, Russia and Brazil.

Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.

VIEKIRAX® + EXVIERA® EU IndicationVIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

Important EU Safety Information
 
Contraindications:VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.

Special warnings and precautions for use:VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.

Pregnancy and concomitant use with ribavirinWhen VIEKIRAX + EXVIERA are used in combination with ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and 6 months after the treatment. Refer to the Summary of Product Characteristics for ribavirin for additional information.

ALT elevationsTransient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.

Use with concomitant medicinal productsUse caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.

Adverse ReactionsMost common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.

Full summary of product characteristics is available at www.ema.europa.eu

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

¹ Feld J, et al. TURQUOISE-III: Safety and Efficacy of 12-week Ribavirin-free Treatment for Patients with HCV Genotype 1b and Cirrhosis. Presented at the 15th Annual International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD) in Berlin, Germany, June 26-28, 2015
² Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15
³ Global Alert and Response (GAR): Hepatitis C. World Health Organisation Web site. http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index2.html#HCV. Published 2003. Accessed November, 2013
⁴ O'Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1. Philadelphia, PA: Saunders Elsevier. 2010:1313-1335

SOURCE AbbVie

For further information: Media, Javier Boix, +1 (847) 937-6113, javier.boix@abbvie.com, or Carlos Taveras, +33 1 41 73 92 64, carlos.taveras@abbvie.com, or Investor Relations, Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com

Study Identifies Characteristics of Patients Likely to have a Potential Living Liver Donor

For Immediate Release
Media Contacts:
Dawn Peters (US) +1 781-388-8408
Tom Griffin (UK) +44 (0) 1865 476213
sciencenewsroom@wiley.com
Follow us on Twitter @WileyResearch


New research published in Liver Transplantation, a journal of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, reports that younger patients, those who are married, and those with Child-Pugh C disease—the most severe measure of liver disease—are more likely immigrants, divorced patients and those at the lowest income levels [and] were less likely to have a potential live donor volunteer for liver donation.
 
With a limited supply of deceased donor organs, livers from living donors provide a much needed, life-saving option for those with end-stage liver disease. Despite evidence suggesting that the 5-year recipient survival from the time of wait listing is estimated to be 20% higher with a live donor compared with deceased donor, living donor liver transplantation accounts for only a few percent in many Western countries.

“Given that the demand for liver transplantation is greater than the supply of deceased donor organs, there is an interest in increasing live donation at centers with experience in that method of transplantation,” explains lead author Dr. Eberhard Renner with the University Health Network and University of Toronto in Ontario, Canada. “Our study aims to identify recipient characteristics that are associated with having a living donor volunteer for donation.”

The research team reviewed data from 491 patients listed for liver transplantation at the University transplant center over a 24-month period. There were 245 patients identified who had a least one potential living donor with 70% of these recipients being male and having an average age of 53 years at wait listing. Hepatitis C, alcoholic liver disease and hepatocellular carcinoma were listed as reason for liver transplant in 34%, 20%, and 35% of cases in the study group.

Analyses found that recipients who had potential access to a living donor were more likely to have more severe liver disease (Child-Pugh C). The recipients were less likely to be older, single, divorced, immigrants or from the lowest income levels. Commenting about the findings Dr. Renner says, “More research is needed to understand and overcome the barriers to live donor liver transplants. Possible interventions like financial assistance and educational programs may help increase liver donation from living donors.”

---

Access the full study on the Wiley Press Room here. (To access PDFs and embargoed stories you must be logged in to the Press Room before clicking the link. Request a login here.) Full citation: "Recipient Factors Associated with Having a Potential Live Liver Donor.” Adam Doyle, Rania N. Rabie, Arastoo Mokhtari, Mark Cattral, Anand Ghanekar, David Grant, Paul Greig, Gary Levy, Leslie Lilly, Ian McGilvray, Markus Selzner, Nazia Selzner and Eberhard L. Renner. Liver Transplantation; (DOI: 10.1002/lt.24148).

URL: http://doi.wiley.com/10.1022/lt.24148
Author Contact: Media wishing to speak with Dr. Renner may contact Alexandra Radkewycz with Toronto General Hospital, University Health Network at Alexandra.Radkewycz@uhn.ca.

About the Journal
Liver Transplantation is published by Wiley on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AASLD and the ILTS, Liver Transplantation delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit http://wileyonlinelibrary.com/journal/lt.

About Wiley
Wiley is a global provider of knowledge and knowledge-enabled services that improve outcomes in areas of research, professional practice and education. Through the Research segment, the Company provides digital and print scientific, technical, medical, and scholarly journals, reference works, books, database services, and advertising. The Professional Development segment provides digital and print books, online assessment and training services, and test prep and certification. In Education, Wiley provides education solutions including online program management services for higher education institutions and course management tools for instructors and students, as well as print and digital content.

VA to outsource care for 180,000 vets with hepatitis C

PHOENIX — The Department of Veterans Affairs is moving to outsource care nationwide for up to 180,000 veterans who have hepatitis C, a serious blood and liver condition treated with expensive new drugs that are costing the government billions of dollars.

The VA has spent weeks developing a dramatic and controversial transition as patient loads have surged and funding has run out. Those efforts were not disclosed until records were released this week to The Arizona Republic.

Instructions on how to carry out the program show that the sickest veterans generally will get top priority for treatment. However, patients who have less than a year to live or who suffer "severe irreversible cognitive impairment" will not be eligible for treatment.

Read more...

Canada: Ontario urged to provide better access to breakthrough hepatitis C drugs

People infected with potentially fatal hepatitis C from tainted blood are pushing Ontario to make them whole by paying for expensive breakthrough drugs considered a virtual cure for the liver disease.

Ontario’s health ministry says 341 Ontarians with stage-two liver disease or worse get Sovaldi or Harvoni pills funded by taxpayers — $60,000 for a 12-week course — under an exceptional access program.

The medications are light-years ahead of previous pharmaceuticals that had troubling side effects and did not work nearly as well.

Doctors say the triage system, in which a FibroScan (a non-invasive liver test) must meet or exceed a specific level of liver damage, can miss patients with complications that would otherwise make them eligible for taxpayer coverage.

Read more...

Diplomat expands hepatitis C specialty services with acquisition of Burman's Specialty Pharmacy

FLINT, Mich., June 19, 2015 /PRNewswire/ -- Diplomat Pharmacy, Inc. (NYSE: DPLO) announced today it has acquired Burman's Specialty Pharmacy (Burman's). Burman's, located in the greater Philadelphia, Pennsylvania area, is a provider of individualized patient care with a primary focus on the challenging condition of hepatitis C.

"Burman's shares our strong commitment to patient care," said Phil Hagerman, Diplomat CEO and Chairman. "We acquired Burman's to enhance our targeted clinical management programs, utilize its innovative hepatitis C technology platform and strong payor network, and increase our presence in the U.S. mid-Atlantic region."

Steve Burman, President and CEO of Burman's, is pleased to partner with Diplomat to continue its history of improving patient results by continually monitoring treatment and ensuring patient compliance. Burman's enhances therapy management through its proprietary software platform HealthTrac, specifically designed to navigate the complexities of hepatitis C therapy and allow pharmacists and providers to collaborate on patient care.

"According to the Center for Disease Control and Prevention, an estimated 3.2 million people in the United States are living with chronic hepatitis C infection," said Hagerman. "We believe the HealthTrac technology will significantly expand our hepatitis C services across our national footprint."

"Diplomat's patient-centric focus echoes our own approach," said Burman. "We pride ourselves on improving patient care with innovative technology. HealthTrac opens the lines of communication between all healthcare professionals involved to improve treatment efficiency in an effort to both improve results and reduce costs. Diplomat shares that vision and puts it into practice with high-touch patient care."

Burman's executive leadership will remain in place as their services expand under Diplomat's ownership. In addition, all individuals and entities receiving Diplomat common stock as part of this transaction will be subject to certain lock-up restrictions on such shares, for at least six months after closing.

Under the terms of the agreement, Diplomat is acquiring Burman's for $72.8 million cash and $10 million in Diplomat common stock. For the 12 months ended May 31, 2015, Burman's generated approximately $383 million in revenue and approximately $21 million in EBITDA. The transaction is expected to be accretive to Diplomat's earnings per share in 2015.  Diplomat funded the cash component of the purchase price with cash on hand along with use of its existing credit facility.

To learn more about Diplomat, visit www.diplomat.is.

About Diplomat

Diplomat (NYSE: DPLO) serves patients and physicians in all 50 states. Headquartered in Flint, Michigan, the company focuses on medication management programs for people with complex chronic diseases, including oncology, immunology, hepatitis, multiple sclerosis, HIV, specialized infusion therapy and many other serious or long-term conditions. Diplomat opened its doors in 1975 as a neighborhood pharmacy with one essential tenet: "Take good care of patients, and the rest falls into place." Today, that tradition continues—always focused on improving patient care and clinical adherence. For more information visit www.diplomat.is. Follow us on Twitter and LinkedIn and like us on Facebook.

About Burman's Specialty Pharmacy

Burman's is a leader in disease-specific treatment programs and has been in business for more than 50 years. Burman's comprehensive services and patient-first approach help patients and physicians navigate the complex waters of a variety of challenging health conditions, all while achieving improved results. Burman's offers individualized pharmaceutical care for a variety of challenging health conditions and complex drug therapies. To learn more, visit www.burmansmedical.com.

CONTACT: INVESTOR CONTACT
Bob East, Westwicke Partners
443.213.0500 | diplomat@westwicke.com

MEDIA CONTACT
Jenny Cretu, Diplomat
810.768.9370 | press@diplomat.is

Logo - http://photos.prnewswire.com/prnh/20140928/148820

SOURCE Diplomat Pharmacy, Inc.

Read complete press release here

China rejects patent linked to Gilead hepatitis C drug

China has rejected a Gilead Sciences Inc patent application related to its costly hepatitis C drug, a U.S. advocacy group said, adding the move may lead to other countries to consider rejecting patents for the controversial treatment.

Gilead has drawn fire for the cost of its top-selling drug Sovaldi, priced at $1,000 per pill in the United States or $84,000 for a typical 12-week course and its patents have been challenged in the U.S., India and Europe.

The application China has rejected was for a so-called prodrug, the inactive form of the drug which then converts into the chemically active compound once in the body, the New York-based Initiative for Medicines, Access & Knowledge (I-MAK) said.

Read more...

Louisville needle swap aims to stop repeat of nearby HIV, hepatitis C outbreaks

A trio of deadly afflictions is ripping through a rural county in southern Indiana.

More than 130 patients in Scott County, Ind., tested positive for HIV in less than a year, making the community of about 24,000 people the site of one of the worst outbreaks in decades.

Among the infected are 114 who also tested positive for another blood-borne disease — hepatitis C, which attacks the liver.

Read more...