EMA recommends avoidance of certain hepatitis C medicines and amiodarone together

Press Release

24/04/2015

Concomitant use may increase risk of slow heart rate and related problems

The European Medicines Agancy (EMA) has confirmed a risk of severe bradycardia (slow heart rate) or heart block (problems with conduction of electrical signals in the heart) when the hepatitis C medicines Harvoni (sofosbuvir with ledipasvir) or a combination of Sovaldi (sofosbuvir) and Daklinza (daclatasvir) are used in patients who are also taking the medicine amiodarone, which is an antiarrhythmic (a medicine used to treat irregular heartbeat).

To manage this risk the Agency recommends that amiodarone should only be used in patients taking these hepatitis C medicines if other antiarrhythmics cannot be given. If concomitant use with amiodarone cannot be avoided, patients should be closely monitored. Because amiodarone persists for a long time in the body, monitoring is also needed if patients start such hepatitis C treatments within a few months of stopping amiodarone.

The recommendations follow a review¹ of cases of severe bradycardia or heart block in patients taking amiodarone who started treatment with the hepatitis C combinations. It was considered that there was a likely relationship of these events to the medicines. The possible mechanism behind these effects is unknown and further investigation of other cases with Sovaldi and other hepatitis C medicines is ongoing.

Information for patients

• A few cases of severe slow heart rate or interference with electrical signals in the heart have been reported in patients taking the medicines Harvoni or Sovaldi plus Daklinza (used to treat hepatitis C, a liver infection) at the same time as the heart medicine amiodarone.
• Most of these cases occurred within 24 hours of starting the hepatitis C medicine but some occurred after up to 12 days. Two of the patients needed treatment with a pacemaker and one patient died.
• Patients who need these hepatitis C combinations should not also be given amiodarone unless there is no other suitable alternative.
• If there is no alternative to giving amiodarone at the same time as the hepatitis C medicine, patients’ heart function must be carefully monitored by the doctor. This may include monitoring in hospital for 48 hours after starting treatment.
• Because amiodarone remains in the body for a long time, monitoring is also needed when the hepatitis C treatment is given to patients who stopped amiodarone treatment within the last few months.
• Patients who are taking Harvoni or Sovaldi and Daklinza at the same time as amiodarone, with or without other heart medicines, and who experience symptoms such as slow heartbeat, dizziness, faintness, unusual tiredness, shortness of breath or chest pain during treatment should contact their doctor immediately.
• Patients who have any concerns about their treatment should discuss them with their doctor or pharmacist.

Information for healthcare professionals

• Severe bradycardia and heart block have been reported in patients taking amiodarone and Harvoni, or amiodarone and a combination of Sovaldi and Daklinza. Of 8 cases reviewed up to April 2015, one case resulted in fatal cardiac arrest and two required pacemaker intervention.
• Onset of bradycardia was within 24 hours of initiating hepatitis C treatment in 6 cases and within 2 to 12 days in the other 2 cases. Rechallenge in the context of continued amiodarone treatment resulted in recurrence of symptomatic bradycardia in 2 cases. Recurrence was also seen on rechallenge with the antivirals 8 days after stopping amiodarone, but not 8 weeks after stopping.
• Amiodarone should only be initiated in patients treated with Harvoni, or Sovaldi plus Daklinza, if other antiarrhythmics are contra-indicated or not tolerated.
• If concomitant use with amiodarone is unavoidable, patients should be closely monitored, particularly during the first weeks of treatment. Those at high risk of bradyarrhythmia should be monitored in an appropriate clinical setting for 48 hours after starting concomitant treatment.
• Due to its long half-life, patients who have discontinued amiodarone within the past few months should also be monitored when starting hepatitis C treatment with Harvoni or Sovaldi plus Daklinza.
• Patients receiving these hepatitis C medicines with amiodarone, with or without other medicines that lower heart rate, should be warned of the symptoms of bradycardia and heart block and should be advised to seek urgent medical advice if they experience them.

The product information for Harvoni, Sovaldi and Daklinza will be updated appropriately. A letter will also be sent to healthcare professionals involved in hepatitis C treatment explaining these risks and the measures to manage them.

Because the number of patients taking amiodarone who have been exposed to Harvoni or Sovaldi in combination with Daklinza is unknown, it is not possible to estimate the incidence of occurrence of these events. The mechanism behind the findings has not been established.

More about the medicine

Harvoni, Sovaldi and Daklinza are among several novel hepatitis C treatments recently evaluated by EMA, which are available as tablets. They have simplified the management of the disease and allow the prospect of curing the infection. Sovaldi (sofosbuvir) was authorised in the EU in January 2014, Daklinza (dataclasvir) in August 2014 and Harvoni (sofosbuvir/ledipasvir) in November 2014.

The active substance sofosbuvir blocks the action of an enzyme called ‘NS5B RNA-dependent RNA polymerase’, while dataclasvir and ledipasvir target a protein called ‘NS5A’; by blocking these targets the medicines stop the hepatitis C virus from multiplying and infecting new cells.

¹The review was in the context of a “safety signal”. A safety signal is information on a new or incompletely documented adverse event that is potentially caused by a medicine and that warrants further investigation. The presence of a safety signal does not necessarily mean that a medicine has caused the reported adverse event.

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Merck’s Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection

Data Sets Include Treatment-Naïve, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection

Merck Remains on Track to Submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in First Half of 2015

Friday, April 24, 2015 1:00 am EDT

VIENNA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentations of data from the company’s ongoing C-EDGE pivotal Phase 3 clinical trial program evaluating the investigational once-daily tablet grazoprevir/elbasvir (100mg/50mg) in patients with or without cirrhosis who are infected with chronic hepatitis C virus (HCV) genotypes 1, 4 or 6 (GT1, 4 or 6).¹ Patients in both the HCV infected, treatment-naïve (C-EDGE TN), and HIV/HCV co-infected, treatment-naïve (C-EDGE CO-INFXN) trials treated for 12 weeks achieved rates of sustained virologic response 12 weeks after the completion of treatment (SVR12) of 95 percent (299/316 and 207/218, respectively). In addition, HCV infected, treatment-experienced patients (C-EDGE TE) treated with or without ribavirin (RBV) for 12 weeks achieved SVR12 rates of 94 percent (98/104) and 92 percent (97/105), respectively, and those treated for 16 weeks achieved SVR12 rates of 97 percent (103/106) and 92 percent (97/105), respectively. These data were presented at The International Liver Congress^TM 2015 – the 50^th annual congress of the European Association for the Study of the Liver (Abstract #G07, E-Poster P0886 and E-Poster P0887). A paper detailing the findings of C-EDGE TN was published online in the Annals of Internal Medicine today.

“Patients with co-morbidities and varying treatment experiences represent important segments of the chronic hepatitis C population in need of additional innovative treatment options,” said Dr. Eric Lawitz, vice president, scientific and research development, The Texas Liver Institute and clinical professor of medicine, The University of Texas Health Science Center, San Antonio. “These findings are important because they demonstrate that a single pill of grazoprevir/elbasvir taken once-daily achieved consistently high rates of SVR12 in the patient populations studied.”

“At Merck, we continue to build upon our clinical experience using grazoprevir/elbasvir across diverse populations of patients infected with chronic hepatitis C virus,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. “We remain on track to submit a New Drug Application with the U.S. Food and Drug Administration in the first half of 2015.”

C-EDGE TN Overview and Additional Findings

C-EDGE TN is a randomized, blinded, placebo-controlled trial evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks. Patients were randomized to an immediate treatment group that received grazoprevir/elbasvir for 12 weeks or to a deferred treatment group that received placebo for 12 weeks, were followed for an additional four weeks, and then received open label grazoprevir/elbasvir for the next 12 weeks. The primary efficacy analysis included those patients who received immediate treatment with grazoprevir/elbasvir or placebo. Of the 316 patients who received immediate treatment with grazoprevir/elbasvir, 50 percent were infected with GT1a, 42 percent with GT1b, six percent with GT4 and three percent with GT6. Overall, 22 percent of patients had liver cirrhosis.

In this study, virologic failure occurred in 13 patients (4%) in the immediate treatment group, including one virologic breakthrough and 12 virologic relapses. Serious adverse events occurred in nine (3%) and three (3%) patients in the immediate treatment and corresponding placebo arms, respectively; none were considered drug-related. The most common adverse events reported (greater than 5% incidence) in the immediate treatment and corresponding placebo groups, were headache (17%, 18%), fatigue (16%, 17%), nausea (9%, 8%) and arthralgia (6%, 6%), respectively.

C-EDGE CO-INFXN Overview and Additional Findings

C-EDGE CO-INFXN is an open label, single-arm study evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 and HIV who received therapy for 12 weeks. Of the 218 patients enrolled in the trial, 66 percent were infected with HCV GT1a, 21 percent with GT1b or other GT1, 13 percent with GT4, and one percent with GT6. Overall, 16 percent of patients had liver cirrhosis.

In this study, virologic failure occurred in seven patients (3%), including six virologic relapses and one reinfection. There were no reported drug-related serious adverse events. The most common (greater than 5% incidence) adverse events reported were fatigue (13%), headache (12%) and nausea (9%).

C-EDGE TE Overview and Additional Findings

C-EDGE TE is a randomized study evaluating the efficacy and safety of once-daily grazoprevir/elbasvir with or without twice-daily RBV in treatment-experienced (prior null response, partial response or relapse with peg-interferon/RBV) patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks or 16 weeks.

12 week arms

Of the 209 patients randomized to the 12 week arms, 105 patients received grazoprevir/elbasvir only and 104 patients received grazoprevir/elbasvir plus RBV. Patients in the grazoprevir/elbasvir only arm comprised 58 percent GT1a, 33 percent GT1b or other GT1 and nine percent GT4. Overall, 35 percent had liver cirrhosis. Among the 104 patients receiving grazoprevir/elbasvir plus RBV, 58 percent were infected with chronic HCV GT1a, 28 percent GT1b or other GT1, and 14 percent GT4. Overall, 34 percent had liver cirrhosis.

In the grazoprevir/elbasvir only and grazoprevir/elbasvir plus RBV arms, six patients in each arm (6%) were reported to have virologic relapse. No patients were reported to have virologic breakthrough or rebound. Serious adverse events were reported in four patients in the grazoprevir/elbasvir only arm (4%) and three patients in the grazoprevir/elbasvir plus RBV arm (3%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (19%, 27%), headache (21%, 20%) and nausea (9%, 14%).

16 week arms

Of the 211 patients enrolled in the 16 week arms, 105 patients received grazoprevir/elbasvir only and 106 patients received grazoprevir/elbasvir plus RBV. In the grazoprevir/elbasvir only arm, 46 percent were infected with chronic HCV GT1a, 46 percent with GT1b or other GT1, five percent with GT4 and four percent with GT6. Overall, 36 percent of patients had liver cirrhosis. Among those in the grazoprevir/elbasvir plus RBV arm, 55 percent were infected with chronic HCV GT1a, 36 percent with GT1b or other GT1, eight percent with GT4, and two percent with GT6. Overall, 35 percent had liver cirrhosis.

Among the patients receiving grazoprevir/elbasvir only, three patients (3%) were reported to have virologic breakthrough or rebound and four patients (4%) were reported to have virologic relapse. No virologic failures occurred in patients receiving grazoprevir/elbasvir plus RBV. Serious adverse events were reported in three patients in the grazoprevir/elbasvir only arm (3%) and four patients in the grazoprevir/elbasvir plus RBV arm (4%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (16%, 30%), headache (19%, 19%) and nausea (4%,17%).

About the C-EDGE Program

C-EDGE is the Phase 3 clinical development program for Merck’s investigational HCV treatment grazoprevir/elbasvir comprising five studies with more than 1,700 patients across more than 25 countries. These studies are evaluating grazoprevir/elbasvir in multiple genotypes (GT1, 4 and 6) and diverse patient populations, including difficult-to-treat patients such as: treatment-experienced, patients with cirrhosis, HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, and those receiving opiate substitution therapies.

Merck’s Commitment to HCV

For nearly 30 years, Merck has been at the forefront of the response to the HCV epidemic. Merck employees are dedicated to applying their scientific expertise, resources and global reach to deliver innovative health care solutions that support people living with HCV worldwide.

About Merck

Today’s Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise except as required by applicable law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

¹ Grazoprevir is an HCV NS3/4A protease inhibitor and elbasvir is an HCV NS5A replication complex inhibitor

Contact:

Merck
Media:
Doris Li , 908-246-5701
or
Sarra Herzog, 201-669-6570
or
Investors:
Joe Romanelli, 908-740-1986
or
Justin Holko, 908-740-1879

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Gilead uses Georgia as free-drug testbed for hepatitis C elimination

Provided by Reuters

Health | Wed Apr 22, 2015 11:58am EDT

Gregg Alton, Gilead's executive vice president, corporate and medical affairs, speaks with the media during a news conference in New Delhi September 15, 2014.

LONDON | By Ben Hirschler

LONDON (Reuters) - Gilead Sciences is seeking to convince governments and multilateral agencies worldwide that hepatitis C can be eliminated with a demonstration project in Georgia offering free drugs to all those who need them.

The unprecedented program will make the Caucasian country a testbed for uprooting the liver-destroying disease, using Gilead's highly effective but costly pill Sovaldi, plus its newer product Harvoni once approved.

Georgia has the world's third highest prevalence of hepatitis C, after Egypt and Mongolia, with nearly 7 percent of adults carrying the virus. It also has a wide range of viral variations and different types of patients.

What is more, the country is a manageable size, with a population of around 5 million, and has viral screening systems, making it ideal for scientific study, according to Gregg Alton, the U.S. drugmaker's head of corporate and medical affairs.

"It is a nice country for us to evaluate," he said in a telephone interview on Wednesday from the European Association for the Study of the Liver annual meeting in Vienna.

The scheme, which has the backing of the U.S. Centers for Disease Control and Prevention, will cover an initial 5,000 patients in 2015, with a second phase treating up to 20,000 a year.

Gilead's hepatitis C drugs, and rival products from the likes of AbbVie, can cure hepatitis C but are out of reach at Western prices to patients in poor countries, with a single Sovaldi pill costing $1,000 in the United States.

While Gilead has slashed the price for several low-income countries to $300 per bottle of 28 pills, it also wants to involve international donors in a broad eradication drive.

"We will take the Georgia data to other countries around the world to really make the case that investment can fundamentally change the disease over time," Alton said.

Alton admits the scheme may prompt other governments to ask for free drugs as well, but he said it was unrealistic to simply give away product globally. Instead, he wants to see international funding along the lines of the Global Fund to Fight AIDS, Tuberculosis and Malaria.

"Gilead cannot cure hepatitis C globally on our backs alone. There have to be other players that come in and make that investment," he said.

(Editing by William Hardy)

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U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C

- The New Drug Application (NDA) was accepted by the U.S. Food and Drug Administration (FDA) and is based on results from the PEARL-I study, which demonstrated up to 100 percent sustained virologic response rates at 12 weeks post-treatment with no discontinuations due to adverse events
- First all-oral, interferon-free therapy being evaluated by the FDA for patients with chronic genotype 4 (GT4) hepatitis C virus (HCV) infection
- AbbVie's investigational regimen has been previously designated as a breakthrough therapy and received priority review by the FDA

NORTH CHICAGO, Ill., April 24, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for the company's, all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV). The NDA is for the treatment of adults with chronic genotype 4 (GT4) hepatitis C virus (HCV) infection.

AbbVie's regimen is the first all-oral, interferon-free therapy being evaluated by the FDA for patients in the United States with chronic GT4 HCV infection. This submission affirms the company's commitment to seeking access to curative* therapy for patients living with chronic HCV infection (*curative is defined as when the virus is no longer detectable in the patient's blood 12 weeks after treatment ends; sustained virologic response [SVR₁₂]).

The FDA granted priority review to AbbVie for the regimen based in part on data from the PEARL-I study, which was recently published online in The Lancet. The FDA grants priority review designation to investigational therapies that treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. This designation shortens the regulatory review period for non-new chemical entity NDAs from the normal 10 months to six months. AbbVie's regimen was also granted a Breakthrough Therapy designation by the FDA on June 30, 2014, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement on at least one clinically significant endpoint compared to available therapy.¹

"We are pleased that the FDA has granted priority review for our all-oral, interferon-free treatment for patients with chronic GT4 HCV infection," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Submission of this NDA further underscores AbbVie's commitment to developing therapies to treat a wide range of patients living with chronic HCV infection."

PEARL-I is an open-label, Phase 2b study that demonstrated 100 percent of GT4 patients without cirrhosis who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49) achieved SVR₁₂ after receiving OBV/PTV/r and RBV for 12 weeks. Additionally, 91 percent of patients who were new to therapy achieved SVR₁₂ (n=40/44) after taking the treatment without RBV.

The Centers for Disease Control and Prevention (CDC) estimates that in the United States, 3.2 million people are chronically infected with HCV.² While genotype 1 (GT1) is the most prevalent form of HCV in the U.S., accounting for approximately 73 percent of all cases, GT4 infection accounts for up to 6 percent of HCV infections.^3,4 Hepatitis C is inflammation of the liver caused by an infection with HCV.⁵ It is transmitted when an infected person's blood enters the bloodstream of another person.⁶ There are six major HCV genotypes (GT1-6).⁷ Presently, there is no vaccine for HCV infection.²

About the PEARL-I Study

PEARL-I is an open-label, Phase 2b study designed to evaluate the safety and efficacy of 12 weeks of treatment with OBV/PTV/r with and without RBV in non-cirrhotic adult patients with chronic GT4 HCV infection who were new to therapy or had failed previous treatment with pegylated interferon and RBV. Treatment-naïve GT4 patients were randomized in a 1:1 ratio to receive OBV/PTV/r with or without RBV. All treatment-experienced GT4 patients received OBV/PTV/r with RBV. In the treatment-naïve group without RBV, on-treatment virologic breakthrough was reported in one patient (2 percent) and two patients (5 percent) experienced post-treatment relapse. There were no virologic failures in the other treatment arms. Patients with GT1b HCV infection were also studied but not included in the efficacy analysis for the NDA submission; the results in patients with GT4 HCV were reported in The Lancet.

There were no discontinuations due to adverse events in PEARL-I. The most commonly reported treatment-emergent adverse events (greater than 15 percent in any group) were headache (29-33 percent), asthenia (weakness) (24-33 percent), fatigue (7-18 percent), nausea (9-17 percent) and insomnia (5-16 percent). One patient had a grade 3 liver function test elevation (aspartate aminotransferase [AST] greater than five times the upper limit of normal), which was asymptomatic and resolved during continued dosing. Four patients with hemoglobin decreases (anemia) required RBV dose reductions; however, none of these patients required blood transfusions or medication to boost their red blood cell production.

About AbbVie's Two Direct-Acting Antiviral HCV Treatment
AbbVie's proposed all-oral antiviral treatment consists of the fixed-dose combination of paritaprevir/ritonavir (150/100mg) co-formulated with ombitasvir (25mg) dosed once daily, co-administered with weight-based ribavirin (1000mg or 1200mg in divided doses, twice daily). The combination of two direct-acting antivirals, each with distinct mechanisms of action, targets and inhibits specific HCV proteins in the viral replication process.

About AbbVie's HCV Clinical Development Program
AbbVie's HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating interferon-free, all-oral treatments with and without ribavirin with the goal of achieving high sustained virologic response rates in as many patients as possible. AbbVie's development programs combining two direct-acting antivirals are studying additional hepatitis C virus (HCV) genotypes.

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 developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

Safety Information
Ombitasvir, paritaprevir, and ritonavir (OBV/PTV/r) and RBV are not approved for the investigational use discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.

There are special safety considerations when prescribing these drugs in approved populations.

OBV/PTV/r must not be used in patients with severe hepatic impairment or with certain medications, which may result in serious and/or life-threatening events or loss of therapeutic effect. OBV/PTV/r can cause increases in certain liver enzyme levels (ALT) and should be monitored during the first four weeks of treatment, and then as clinically indicated thereafter. Female patients should not take ethinyl estradiol-containing medications during treatment with OBV/PTV/r, as they are at greater risk for liver enzyme elevations when taking these medications.

Ritonavir must also not be used in patients with known hypersensitivity to ritonavir or any of its excipients.

Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score ≥6.

See approved product labels for more 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. AbbVie employs more than 26,000 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 2014 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.

¹ U.S. Food and Drug Administration Online. Fact Sheet: Breakthrough Therapies. http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm329491.htm. Accessed March 20, 2015.
² Centers for Disease Control and Prevention (CDC). Hepatitis C FAQs for health professionals. http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Accessed March 10, 2015.
³ 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.
⁴ Gower E, Estes C, Blach S, et al. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatology. 2014;61:S45-S57.
⁵ Mayo Clinic. Hepatitis C: Definition. http://www.mayoclinic.org/diseases-conditions/hepatitis-c/basics/definition/con-20030618. Accessed November 2013.
⁶ World Health Organization. Hepatitis C Fact Sheet 2014. http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed April 2014.
⁷ AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed March 9, 2015.

SOURCE AbbVie

For further information: Media: Stefanie Prodouz, +1 (224) 637-0971, stefanie.prodouz@abbvie.com; David Freundel, +1 (847) 937-4522, david.freundel@abbvie.com; Investor Relations: Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com

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