`Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C
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`October 10, 2014 1:55 PM ET
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`-- Harvoni Achieved Cure Rates (SVR12) of 94-99 Percent in Three Phase 3 Studies --
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`-- Shortens Treatment Duration to Just Eight Weeks for Certain Treatment-Naïve Patients --
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`-- Eliminates Need for Interferon and Ribavirin for Patients with Genotype 1 Hepatitis C --
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`FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 10, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that
`the U.S. Food and Drug Administration (FDA) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first
`once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines
`the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the tradename
`Sovaldi® in December 2013. Harvoni’s efficacy has been established in patients with chronic hepatitis C virus (HCV)
`genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis
`status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients
`without cirrhosis who have baseline HCV viral load below 6 million IU/mL.
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`Harvoni Product Photo
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`This press release has an accompanying Smart Marketing Page featuring additional multimedia and information, which can
`be found at: http://smp.businesswire.com/pages/us-food-and-drug-administration-approves-gileads-harvoni-
`ledipasvirsofosbuvir-first-once-daily.
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`The FDA granted Harvoni a Priority Review and Breakthrough Therapy designation, which is given to investigational
`medicines that may offer major advances in treatment over available therapies.
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`“By providing very high cure rates in as little as eight weeks and completely eliminating the need for interferon and
`ribavirin, which are challenging to take and tolerate, Harvoni significantly advances treatment for patients with the most
`common form of hepatitis C in the United States,” said Nezam Afdhal, MD, Director of Hepatology at Beth Israel
`Deaconess Medical Center, Professor of Medicine at Harvard Medical School and a principal investigator in the Harvoni
`clinical trials. “For the first time, the vast majority of patients can be cured with a once-daily pill in only eight or 12
`weeks.”
`Gilead 2005
`I-MAK v. Gilead
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`Harvoni’s approval is supported by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated
`eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients
`with compensated liver disease. These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and
`non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an
`interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for
`each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12).
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`Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response
`rates. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94 to 99 percent.
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`“Unlike other serious chronic diseases, hepatitis C can be cured and Harvoni offers patients the potential for a cure in as
`little as eight weeks,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “Gilead is proud
`to have played a role in developing a once-daily therapy that is safe, simple and well tolerated. We are now working to
`ensure rapid and broad access to Harvoni.”
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`Important Safety Information regarding warnings and precautions, adverse reactions and drug interactions is listed below.
`Zero percent, less than 1 percent and 1 percent of patients treated for eight, 12 and 24 weeks, respectively, discontinued
`treatment due to adverse events and fewer adverse events were observed in the ribavirin-free arms compared to the
`ribavirin-containing arms in all ION studies. The most common adverse reactions among patients treated with Harvoni (≥5
`percent) were fatigue, headache, nausea, diarrhea and insomnia. For additional study details, and complete dosing
`information, see the Clinical Studies and Dosage and Administration sections, respectively, of the full Prescribing
`Information.
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`U.S. Patient Support Program
`To assist eligible hepatitis C patients in the United States with access to Harvoni, Gilead has added the medicine to its
`Support Path™ (www.MySupportPath.com) program. The program consists of an integrated offering of support services
`for patients and providers, among them:
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`Call center staffed with associates trained to help patients and their providers with insurance-related needs.
`Education and support, including a 24/7 nursing support service line.
`The Harvoni and Sovaldi Co-pay Coupon Programs, which provide co-pay assistance for eligible patients with
`private insurance who need assistance paying for out-of-pocket medication costs. Most patients will pay no more
`than $5 per co-pay.
`The Support Path Patient Assistance Program, which will provide Harvoni and Sovaldi at no charge for eligible
`patients with no other insurance options.
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`Gilead also provides support to independent non-profit organizations that provide assistance for eligible federally-insured
`and privately-insured patients who need help covering out-of-pocket medication costs.
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`To learn more about Support Path for Harvoni or Sovaldi, please visit www.MySupportPath.com or call 1-855-769-7284
`between 9:00 a.m. – 8:00 p.m. Eastern, Monday through Friday.
`
`IMPORTANT SAFETY INFORMATION
`Warnings and Precautions
`Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers: Rifampin and St. John’s wort are not
`recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.
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`Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir
`(Sovaldi).
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`Adverse Reactions
`Most common (≥10%, all grades) adverse reactions were fatigue and headache.
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`Drug Interactions
`In addition to rifampin and St. John’s wort, coadministration of Harvoni is also not recommended with carbamazepine,
`oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected
`to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.
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`Coadministration of Harvoni is not recommended with simeprevir due to increased concentrations of ledipasvir and
`simeprevir. Coadministration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat
`/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively.
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`Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions,
`including clinical comments.
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`About Gilead Sciences
`Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in
`areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening
`diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe
`and Asia Pacific.
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`Forward-Looking Statement
`This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act
`of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians and patients may not
`see advantages of Harvoni over other therapies and may therefore be reluctant to prescribe the product, and the risk that
`private and public payers may be reluctant to provide coverage or reimbursement for the product. These risks,
`uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking
`statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in
`detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, as filed with the U.S. Securities
`and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and
`Gilead assumes no obligation to update any such forward-looking statements.
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`U.S. Full Prescribing Information for Harvoni and Sovaldi is available at www.gilead.com.
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`Harvoni, Sovaldi and Support Path are trademarks or registered trademarks of Gilead Sciences, Inc., or its related
`companies.
`
`For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter
`(@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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`Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20141010005587/en/
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`Source: Gilead Sciences, Inc.
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`Gilead Sciences, Inc.
`Patrick O’Brien, Investors, 650-522-1936
`Cara Miller, Media, 650-522-1616
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