U.S. Food and Drug Administration Approves Gilead’s Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C

  U.S. Food and Drug Administration Approves Gilead’s Sovaldi™ (Sofosbuvir)
  for the Treatment of Chronic Hepatitis C

            – Sovaldi Approved for Use in Genotypes 1, 2, 3 or 4 –

 – High Cure Rates (SVR12) and Shortened, 12-Week Course of Therapy for Many
                                  Patients –

          – First Ever Oral Treatment Regimen for Genotypes 2 or 3 –

  – First Regimen for Patients Awaiting Liver Transplantation to Prevent HCV
                                 Recurrence –

Business Wire

FOSTER CITY, Calif. -- December 6, 2013

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and
Drug Administration (FDA) has approved Sovaldi™ (sofosbuvir) 400 mg tablets, a
once-daily oral nucleotide analog polymerase inhibitor for the treatment of
chronic hepatitisC (CHC) infection as a component of a combination antiviral
treatment regimen. Sovaldi’s  efficacy has been established in subjects with
hepatitis C virus (HCV) genotypes 1, 2, 3 or 4 infection, including those with
hepatocellular carcinoma meeting Milan criteria (awaiting liver
transplantation) and those with HCV/HIV-1 co-infection. Recommended regimens
and treatment duration for Sovaldi combination therapy in HCV mono-infected or
HCV/HIV-1 co-infected patients follows:

Sovaldi Product Photo

Sovaldi Product Photo

                   Treatment                         Duration
Genotype 1 or 4     Sovaldi + peg-interferon alfa     12 weeks
                        + ribavirin
Genotype 2          Sovaldi + ribavirin               12 weeks
Genotype 3          Sovaldi + ribavirin               24 weeks

Sovaldi in combination with ribavirin for 24 weeks can be considered for CHC
patients with genotype 1 infection who are interferon ineligible.
Additionally, Sovaldi should be used in combination with ribavirin for
treatment of CHC patients with hepatocellular carcinoma awaiting liver
transplantation for up to 48 weeks or until liver transplantation to prevent
post-transplant HCV infection. Treatment regimen, duration and response to
Sovaldi are dependent on viral genotype and patient population, and associated
baseline factors. Monotherapy is not recommended. Full Prescribing Information
will be available on www.Gilead.com.

The FDA granted Sovaldi Priority Review and Breakthrough Therapy designation,
which is granted to investigational medicines that may offer major advances in
treatment over existing options.

“I believe that Sovaldi will have a major impact on public health by
significantly increasing the number of Americans who are cured of hepatitis
C,” said Ira Jacobson, MD, Chief of the Division of Gastroenterology and
Hepatology, Weill Cornell Medical College, New York City and a principal
investigator in the Sovaldi clinical trials. “In clinical studies, Sovaldi in
combination with other agents achieved very high cure rates while shortening
the duration of treatment to as little as 12 weeks and reducing or completely
eliminating the need for interferon injections, depending on the viral

Chronic hepatitis C affects an estimated 4 million people in the United
States, the majority of whom are “baby boomers” – individuals born between
1945 and 1965. The disease is the nation’s leading cause of liver cancer and
liver transplantation, and in recent years has surpassed HIV/AIDS as a cause
of death. The current standard of care for HCV involves up to 48 weeks of
therapy with a pegylated interferon (peg-IFN)/ribavirin (RBV)-containing
regimen, which may not suitable for certain types of patients.

“It is our hope that Sovaldi will mark the beginning of a new era in hepatitis
C treatment. Gilead is proud to have played a role in bringing about this
important therapeutic advance and we would like to extend our thanks to the
many patients and physicians who partnered with us on Sovaldi’s clinical
studies,” said John C. Martin, PhD, Chairman and Chief Executive Officer,
Gilead Sciences.

Sovaldi’s approval is supported primarily by data from four Phase 3 studies,
NEUTRINO, FISSION, POSITRON and FUSION, which evaluated 12 or 16 weeks of
treatment with Sovaldi combined with either RBV or RBV plus peg-IFN. Three of
these studies evaluated Sovaldi plus RBV in genotype 2 or 3 patients who were
either treatment-naïve (FISSION), treatment-experienced (FUSION) or peg-IFN
intolerant, ineligible or unwilling (POSITRON). NEUTRINO evaluated Sovaldi in
combination with Peg-IFN/RBV in treatment naïve patients with genotypes 1, 4,
5 or 6. In these studies, Sovaldi-based therapy was found to be superior to
historical controls (NEUTRINO and FUSION) or to placebo (POSITRON), or
non-inferior to currently available treatment options (FISSION) based on the
proportion of patients who had a sustained virologic response (HCV
undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve
SVR12 are considered cured of HCV. Trial participants taking Sovaldi-based
therapy achieved SVR12 rates of 50-90 percent. For full study details, see the
Clinical Studies section of the full Prescribing Information.

During the FDA’s review, data from two additional Phase 3 studies, VALENCE and
PHOTON-1, were added to the NDA as a result of the Breakthrough Designation
status. In the VALENCE study, patients with genotype 3 HCV infection were
treated with Sovaldi and RBV for 24 weeks. Eighty-four percent of patients in
this trial achieved SVR12. The PHOTON-1 study evaluated Sovaldi and RBV for 12
weeks in patients with genotype 2 HCV infection co-infected with HIV-1 and for
24 weeks in patients with genotypes 1 or 3 HCV co-infected with HIV-1. Trial
participants achieved SVR12 rates of 76-92 percent. In all Phase 3 studies of
Sovaldi, no viral resistance to the drug was detected among patients who
relapsed following completion of therapy.

To date, nearly 3,000 patients have received at least one dose of Sovaldi in
Phase 2 or 3 studies. Sovaldi combination therapy was well tolerated in
clinical studies. Adverse events were generally mild and there were few
treatment discontinuations due to adverse events. The most common adverse
events occurring in at least 20 percent of patients receiving Sovaldi in
combination with Peg-IFN/RBV were fatigue, headache, nausea, insomnia and
anemia; see below for Important Safety Information regarding
contraindications, warnings and precautions, adverse reactions and drug

On November 22, 2013, the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) issued a positive opinion on
Gilead’s application for marketing authorization for Sovaldi. The CHMP opinion
was adopted following an accelerated review procedure, which is reserved for
medicinal products that are expected to be of major public health interest.
This assessment does not guarantee marketing authorization by the European
Commission. If approved, Sovaldi could be available in the European Union in
the first quarter of 2014. Applications for marketing approval of Sovaldi are
also pending in Australia, Canada, New Zealand, Switzerland and Turkey.

Dr. Jacobson is a paid consultant to Gilead.

The Wholesaler Acquisition Cost (WAC) of a 28-tablet bottle of Sovaldi in the
United States is $28,000.

U.S. Patient Assistance Program

Gilead is committed to ensuring that people with hepatitis C can access
Sovaldi and has launched Support Path™ (www.MySupportPath.com) to provide
assistance to patients who are uninsured, underinsured or who need financial
assistance to pay for the medicine. The program consists of an integrated
offering of support services for patients and providers, including:

  *Access to dedicated case managers to help patients and their providers
    with insurance-related needs, including identifying alternative coverage
    options such as federally-insured programs (e.g., Medicaid, Medicare) and
    health exchanges.
  *Education and support, including a 24/7 nursing support service line and
    the ability to schedule an onsite visit from a clinical educator.
  *The Sovaldi Co-pay Coupon Program, which provides 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. Co-pay assistance can also be applied toward deductibles and
    co-insurance obligations.
  *Gilead will provide support to the Patient Access Network (PAN)
    Foundation, an independent non-profit organization that provides
    assistance for eligible federally-insured and privately-insured patients
    who need help covering out-of-pocket medication costs.
  *The Support Path Patient Assistance Program will provide Sovaldi at no
    charge for eligible patients with no other insurance options.

Information about how to apply for any of these forms of assistance can be
found at www.MySupportPath.com or by calling 1-855-7MyPath (1-855-769-7284)
between 9 a.m. - 8 p.m. EST.

Global Availability

Gilead is committed to helping ensure access to Sovaldi in resource-limited
settings. The company is developing a hepatitis C treatment access program,
focusing on those countries with the greatest HCV burden. Full program details
will be announced in the coming months.

About Sovaldi

Sovaldi is an oral nucleotide analog inhibitor of the HCV NS5B polymerase
enzyme, which plays an essential role in HCV replication. Sovaldi is a
direct-acting agent, meaning that it interferes directly with the HCV life
cycle by suppressing viral replication. Treatment regimen and duration for
Sovaldi are dependent on both viral genotype and patient population. Treatment
response varies based on baseline host and viral factors. Monotherapy is not
recommended for treatment of CHC.

Note to editors: Additional multimedia and information can be found at



Sovaldi combination treatment with ribavirin or with peginterferon alfa plus
ribavirin is contraindicated in women who are pregnant or may become pregnant
and men whose female partners are pregnant because of the risk for birth
defects and fetal death associated with ribavirin. Contraindications to
peginterferon alfa and ribavirin also apply to Sovaldi combination treatment.
Refer to the prescribing information of peginterferon alfa and ribavirin for a
list of their contraindications.

Warnings and Precautions

  *Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin: Ribavirin
    therapy should not be started unless a report of a negative pregnancy test
    has been obtained immediately prior to initiation of therapy. Female
    patients of childbearing potential and their male partners must use two
    forms of non-hormonal contraception during treatment and for at least 6
    months after treatment has concluded. Routine monthly pregnancy tests must
    be performed during this time. Refer to the prescribing information for
  *Use with Potent P-gp Inducers: Rifampin and St. John’s wort should not be
    used with Sovaldi as they may significantly decrease sofosbuvir plasma
    concentration, reducing its therapeutic effect.

Adverse Reactions

Most common (≥20%, all grades) adverse reactions for:

  *Sovaldi + peginterferon alfa + ribavirin combination therapy were fatigue,
    headache, nausea, insomnia, and anemia
  *Sovaldi + ribavirin combination therapy were fatigue, and headache

Drug Interactions

In addition to rifampin and St. John’s wort, coadministration of Sovaldi is
not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin,
rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is
expected to decrease the concentration of sofosbuvir, reducing its therapeutic

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.

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 Sovaldi over other therapies and may
therefore be reluctant to prescribe the product, and the risk that public
payers may be reluctant to approve or provide reimbursement for the product.
In addition, pending marketing applications for Sovaldi in theEuropean Union
and other territories may not be approved in the currently anticipated
timelines or at all, and marketing approval, if granted, may have significant
limitations on its use. 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 September 30,
2013, 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

 U.S. full prescribing information for Sovaldi is available at www.Gilead.com

  Sovaldi and Support Path are trademarks or registered trademarks of Gilead
                                Sciences, Inc.

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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