AbbVie Receives U.S. FDA Approval of VIEKIRA PAK™ (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C

NORTH CHICAGO, Ill., Dec. 19, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved AbbVie's (NYSE:ABBV) VIEKIRA PAK™, an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis. VIEKIRA PAK is the only FDA-approved regimen that contains three distinct mechanisms of action - NS5A inhibitor, NS3/4A protease inhibitor and a non-nucleoside NS5B polymerase inhibitor - that work together to attack the virus at three separate stages of the disease lifecycle to inhibit it from reproducing.

"We are proud of the work of our research and development organization to bring this important therapy, offering high cure rates, to patients with hepatitis C. We believe appropriate patients, regardless of their fibrosis stage, should have broad market access to VIEKIRA PAK, and we are committed to supporting access to this therapy," said Richard Gonzalez, Chairman of the Board and Chief Executive Officer, AbbVie. "This is the first of several potential new therapies that we are advancing to treat a multitude of serious disease states, and we anticipate bringing them to market in the coming years."

The approval of VIEKIRA PAK is supported by a robust clinical development program designed to study the safety and efficacy of the regimen in more than 2,300 enrolled patients across 25 countries. The program consisted of six pivotal Phase 3 studies, which demonstrated that VIEKIRA PAK cured 95-100 percent of GT1a and GT1b hepatitis C patients, including patients new and experienced to treatment, and patients with compensated cirrhosis, with less than 2 percent of patients experiencing virological failure. Additionally, more than 98 percent of patients in clinical trials completed a full course of therapy.

VIEKIRA PAK's approval is also based on the results from Phase 2 clinical trials, which showed that VIEKIRA PAK cured 97 percent of liver transplant recipients and 92 percent of patients co-infected with HCV/HIV-1. Patients who achieve a sustained virologic response (SVR₁₂) are considered cured of HCV.

"AbbVie's clinical trial program includes landmark, placebo-controlled studies evaluating a wide variety of patients with hepatitis C," said Fred Poordad, M.D., vice president, academic and clinical affairs, the Texas Liver Institute and Professor of Medicine, University of Texas Health Science Center, San Antonio, and investigator for several VIEKIRA PAK trials. "The studies have shown that treatment with VIEKIRA PAK resulted in high cure rates, even in patients who have historically been challenging to treat, such as patients with cirrhosis, patients who have had liver transplants and patients co-infected with HIV."  

HCV is the most common, blood-borne infection in the United States, affecting more than 3.2 million Americans, which is nearly three times as many people affected by the human immunodeficiency virus (HIV). More than 70 percent of all HCV patients have GT1 infection. It is estimated that more than 1 million people currently living with HCV will develop cirrhosis (scarring of the liver) by the year 2020, and with HCV-related liver transplants on the rise, it has become a critical public health issue. As the population ages and HCV progresses, it is projected that total annual direct medical costs of HCV in the U.S. will reach $85 billion over the next 20 years.

"Treating hepatitis C is complex because the virus mutates and replicates rapidly. With so many Americans affected by HCV, it is critical that patients have access to a regimen that, in clinical trials, produced high cure rates with low rates of treatment failures, even in the most difficult-to-treat patients," said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie.

For people living with hepatitis C who face financial difficulties, the AbbVie Patient Assistance Program provides medication at no cost. A co-pay assistance program will be available for commercially-insured patients being treated with VIEKIRA PAK. Out-of-pocket costs for eligible patients could be as little as $5.00 per month. 

Additionally, AbbVie has launched a patient support program, called proCeed™, which is intended to provide a broad range of patient support options. The proCeed program can be accessed soon at www.viekira.com or by calling 1-844-2-PROCEED.

AbbVie also supports independent non-profit organizations that assist eligible patients enrolled in federal and private insurance plans with their out-of-pocket medication costs.

2015 Outlook
AbbVie expects to provide earnings-per-share guidance for 2015 in early January. The company will provide detailed 2015 guidance, including product sales estimates and other financial metrics, on its fourth quarter earnings conference call, scheduled for January 30, 2015.

About VIEKIRA PAK™
VIEKIRA PAK™ (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets) has been studied in a broad range of genotype 1 (GT1) patients with chronic hepatitis C virus (HCV) infection, ranging from treatment-naive to some of the most difficult to treat, such as patients with compensated (mild, Child-Pugh A) cirrhosis of the liver, HCV/HIV-1 co-infection, liver transplant recipients with normal hepatic function and mild fibrosis, and those who have failed previous treatment with pegylated interferon (pegIFN) and ribavirin (RBV). VIEKIRA PAK is not recommended in patients with moderate hepatic impairment (Child-Pugh B), and is contraindicated in patients with severe hepatic impairment (Child-Pugh C). VIEKIRA PAK consists of the fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir 100mg (an approved HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal. VIEKIRA PAK is taken for 12 weeks, except in certain GT1a patients with cirrhosis, who should take it for 24 weeks. Ribavirin should be co-administered in GT1a patients, and in all patients who have cirrhosis or who have received a liver transplant.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir is being investigated by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

VIEKIRA PAK was granted priority review and designated as a Breakthrough Therapy by the U.S. FDA, a status given to medicines or regimens that may offer substantial improvement over available therapies.

Full Prescribing Information, including the Medication Guide, can be found here.

Use and Important Safety Information

USE
VIEKIRA PAK™ (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C virus (HCV) infection, including people who have a certain type of cirrhosis (compensated).

VIEKIRA PAK is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a healthcare provider before taking VIEKIRA PAK.

IMPORTANT SAFETY INFORMATION

When taking VIEKIRA PAK in combination with ribavirin, people should also read the Medication Guide that comes with ribavirin, especially the important pregnancy information.

What is the most important information to know about VIEKIRA PAK?
VIEKIRA PAK can cause increases in liver function blood test results, especially if people use ethinyl estradiol-containing medicines (such as some birth control products).

• Ethinyl estradiol-containing medicines (combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen Lo®, Ortho Evra®; hormonal vaginal rings such as NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®) must be stopped before starting treatment with VIEKIRA PAK. If these medicines are used as a method of birth control, another method must be used during treatment with VIEKIRA PAK, and for about 2 weeks after treatment with VIEKIRA PAK ends. A healthcare provider can provide instruction on when to begin taking ethinyl estradiol-containing medicines.
  
  
• A healthcare provider should do blood tests to check liver function during the first 4 weeks of treatment and then as needed.
  
  
• A healthcare provider may tell people to stop taking VIEKIRA PAK if signs or symptoms of liver problems develop. A healthcare provider must be notified right away if any of the following symptoms develop or if they worsen during treatment with VIEKIRA PAK: tiredness, weakness, loss of appetite, nausea, vomiting, yellowing of the skin or eyes, or color changes in stools.

VIEKIRA PAK must not be taken if people:

• have severe liver problems
  
  

• take any of the following medicines: alfuzosin hydrochloride (Uroxatral®) - carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) - efavirenz (Sustiva®, Atripla®) - ergot containing medicines including ergotamine tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, Wigraine®, Wigrettes®), dihydroergotamine mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®, Methergine®) - ethinyl estradiol-containing medicines - gemfibrozil (Lopid®) - lovastatin (Advicor®, Altoprev®, Mevacor®) - midazolam (when taken by mouth) - phenytoin (Dilantin®, Phenytek®) - phenobarbital (Luminal®) - pimozide (Orap®) - rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) - sildenafil citrate (Revatio®) when taken for pulmonary artery hypertension (PAH) - simvastatin (Zocor®, Vytorin®, Simcor®) - St. John's wort (Hypericum perforatum) or a product that contains St. John's wort - triazolam (Halcion®).
  

• have had a severe skin rash after taking ritonavir (Norvir®).

What should people tell a healthcare provider before taking VIEKIRA PAK?

• If they have: liver problems other than HCV infection, HIV infection, or any other medical conditions.
• If they have had a liver transplant. If they take the medicines tacrolimus (Prograf®) or cyclosporine (Gengraf®, Neoral®, Sandimmune®), a healthcare provider should check blood levels, and, if needed, may change the dose of these medicines or how often they are taken, both during and after treatment with VIEKIRA PAK.
• If they are pregnant or plan to become pregnant or if they are breastfeeding or plan to breastfeed. It is not known if VIEKIRA PAK will harm a person's unborn baby or pass into breast milk. A healthcare provider should be consulted about the best way to feed a baby if taking VIEKIRA PAK. For pregnant females that have both HCV and HIV infection, they should talk with a healthcare provider about enrolling in the antiretroviral pregnancy registry.
• About all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with VIEKIRA PAK.
  • A new medicine must not be started without telling a healthcare provider. A healthcare provider will provide instruction on whether it is safe to take VIEKIRA PAK with other medicines.
  • When VIEKIRA PAK is finished, a healthcare provider should be consulted on what to do if one of the usual medicines taken was stopped or if the dose changed during VIEKIRA PAK treatment.

What are the common side effects of VIEKIRA PAK?

• For VIEKIRA PAK used with ribavirin, side effects include tiredness, nausea, itching, skin reactions such as redness or rash, sleep problems, and feeling weak.
• For VIEKIRA PAK used without ribavirin, side effects include nausea, itching, and sleep problems.

These are not all of the possible side effects of VIEKIRA PAK. A healthcare provider 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 VIEKIRA. For more information, talk with a 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.

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. AbbVie employs approximately 25,000 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.

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 2013 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.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/abbvie-receives-us-fda-approval-of-viekira-pak-ombitasvirparitaprevirritonavir-tablets-dasabuvir-tablets-for-the-treatment-of-chronic-genotype-1-hepatitis-c-300012758.html

SOURCE AbbVie

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