Market Overview

U.S. FDA Approves New Indications for Harvoni® and Sovaldi® in Pediatric Patients 12 Years and Older with Chronic Hepatitis C Infection

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Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food
and Drug Administration (FDA) has approved supplemental indications for
Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and
Sovaldi® (sofosbuvir 400 mg) tablets for the treatment of
chronic hepatitis C virus (HCV) infection in adolescents without
cirrhosis or with compensated cirrhosis, 12 years of age and older, or
weighing at least 35kg. Harvoni was approved for pediatric patients with
genotype 1, 4, 5 or 6 chronic HCV infection. Sovaldi was approved for
pediatric patients with genotype 2 or 3 chronic HCV infection, in
combination with ribavirin. There are an estimated 23,000-46,000
pediatric HCV patients in the United States, most of whom were infected
with the virus at birth.

"The approvals of Sovaldi and Harvoni for pediatric patients will enable
adolescents to finally benefit from interferon-free treatment for HCV
infection," said Karen Murray, M.D., professor of pediatrics at the
University of Washington School of Medicine and Seattle Children's.
"These therapies address a significant unmet medical need and represent
an important advance for HCV-infected adolescents."

"Gilead's goal is to develop and deliver treatments that provide all
patients with HCV the potential to be cured," said Norbert
Bischofberger, Ph.D., Executive Vice President of Research and
Development and Chief Scientific Officer at Gilead. "For the first time,
children 12 and older in the United States with genotypes 1 through 6
chronic HCV infection now have options of two direct-acting antiviral
regimens that offer high cure rates while eliminating the need for
interferon injections."

Harvoni and Sovaldi each have a boxed warning in their respective
product labels regarding the risk of hepatitis B virus reactivation in
HCV/HBV co-infected patients. See below for important safety information.

Harvoni for Pediatric Patients

The supplemental new drug application (sNDA) approval is supported by
data from an open-label clinical trial (Study 1116), which evaluated 12
weeks of treatment with Harvoni once-daily in genotype 1 treatment-naïve
and treatment-experienced HCV-infected adolescents 12 years of age and
older without cirrhosis or with compensated cirrhosis. The SVR12 rate
was 98 percent overall (98/100). No subject experienced on-treatment
virologic failure or relapse. Two subjects were lost to follow-up.

Adverse events were consistent with those observed in clinical studies
of Harvoni in adults. The most common adverse reactions (≥10 percent,
all grades) observed with treatment with Harvoni in HCV-infected
pediatric patients were fatigue, headache and asthenia.

Sovaldi for Pediatric Patients

The sNDA approval is supported by data from an open-label clinical trial
(Study 1112), which evaluated 12 or 24 weeks of treatment with Sovaldi
and weight-based ribavirin in adolescents 12 years of age and older with
HCV genotype 2 or 3. The SVR12 rate was 100% (13/13) in genotype 2
patients and 97% (36/37) in genotype 3 patients. No subject experienced
on-treatment virologic failure or relapse. One patient was lost to
follow up.

Adverse events were consistent with those observed in clinical studies
of Sovaldi in adults. The most common adverse reactions (≥15 percent,
all grades) observed with treatment with Sovaldi and ribavirin for 12 or
24 weeks in HCV-infected pediatric patients were fatigue, headache and
nausea.

U.S. Patient Support Program

To support these patients and their families, Gilead's U.S. Support
Path® program provides information regarding access and reimbursement
coverage options to patients in the United States who need assistance
with coverage for their medications, including Harvoni and Sovaldi.
Support Path conducts benefits investigations and provides patients with
information regarding their insurance options.

Further, the Harvoni and Sovaldi Co-pay Coupon Programs offer co-pay
assistance for eligible patients with private insurance who need
assistance paying for out-of-pocket medication costs.

Information about how to enroll can be found at either https://www.harvoni.com/support-and-savings/onward
or https://www.sovaldi.com/coupons
or by calling 1-855-7-MYPATH (1-855-769-7284) between 9:00 a.m. and 8:00
p.m. (Eastern).

Important Safety Information for Harvoni

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV
COINFECTED PATIENTS

Test all patients for evidence of current or prior hepatitis B virus
(HBV) infection before initiating treatment with Harvoni. HBV
reactivation has been reported in HCV/HBV coinfected patients who were
undergoing or had completed treatment with HCV direct acting antivirals
(DAAs) and were not receiving HBV antiviral therapy. Some cases have
resulted in fulminant hepatitis, hepatic failure, and death.
Cases
have been reported in patients who are HBsAg positive, in patients with
serologic evidence of resolved HBV, and also in patients receiving
certain immunosuppressant or chemotherapeutic agents; the risk of HBV
reactivation associated with treatment with HCV DAAs may be increased in
patients taking these other agents. Monitor HCV/HBV coinfected patients
for hepatitis flare or HBV reactivation during HCV treatment and
post-treatment follow-up. Initiate appropriate patient management for
HBV infection as clinically indicated.

Contraindications

  • If Harvoni is used in combination with ribavirin (RBV), all
    contraindications, warnings and precautions, in particular pregnancy
    avoidance, and adverse reactions to RBV also apply. Refer to RBV
    prescribing information.

Warnings and Precautions

  • Risk of Serious Symptomatic Bradycardia When Coadministered with
    Amiodarone: Amiodarone is not recommended for use with Harvoni due to
    the risk of symptomatic bradycardia, particularly in patients also
    taking beta blockers or with underlying cardiac comorbidities and/or
    with advanced liver disease. In patients without alternative, viable
    treatment options, cardiac monitoring is recommended. Patients should
    seek immediate medical evaluation if they develop signs or symptoms of
    bradycardia.
  • 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.

Adverse Reactions

Most common (≥10%, all grades) adverse reactions were fatigue, headache
and asthenia.

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.
  • 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.

Consult the full Prescribing Information for Harvoni for more
information on potentially significant drug interactions, including
clinical comments.

Important Safety Information for Sovaldi

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV
COINFECTED PATIENTS

Test all patients for evidence of current or prior hepatitis B virus
(HBV) infection before initiating treatment with Sovaldi. HBV
reactivation has been reported in HCV/HBV coinfected patients who were
undergoing or had completed treatment with HCV direct acting antivirals
(DAAs) and were not receiving HBV antiviral therapy. Some cases have
resulted in fulminant hepatitis, hepatic failure, and death.
Cases
have been reported in patients who are HBsAg positive, in patients with
serologic evidence of resolved HBV, and also in patients receiving
certain immunosuppressant or chemotherapeutic agents; the risk of HBV
reactivation associated with treatment with HCV DAAs may be increased in
patients taking these other agents. Monitor HCV/HBV coinfected patients
for hepatitis flare or HBV reactivation during HCV treatment and
post-treatment follow-up. Initiate appropriate patient management for
HBV infection as clinically indicated.

Contraindications

  • 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

  • Risk of Serious Symptomatic Bradycardia When Coadministered with
    Amiodarone and Another HCV Direct Acting Antiviral (DAA): Amiodarone
    is not recommended for use with Sovaldi in combination with another
    DAA due to the risk of symptomatic bradycardia, particularly in
    patients also taking beta blockers or with underlying cardiac
    comorbidities and/or with advanced liver disease. In patients without
    alternative, viable treatment options, cardiac monitoring is
    recommended. Patients should seek immediate medical evaluation if they
    develop signs or symptoms of bradycardia.
  • Risk of Reduced Therapeutic Effect of Sovaldi Due to Use with P-gp
    Inducers: Rifampin and St. John's wort are not recommended for use
    with Sovaldi as they may significantly decrease sofosbuvir plasma
    concentrations.
  • Risk Associated with Combination Treatment: Because Sovaldi is used in
    combination with other antiviral drugs for the treatment of HCV
    infection, consult the Prescribing Information for these drugs.

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 effect.

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. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City, California.

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 may not see the benefits of prescribing Harvoni or
Sovaldi in pediatric patient populations with HCV infection. 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
Annual Report on Form 10-K for the year ended December 31, 2016, 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.

Full prescribing information for Harvoni and Sovaldi, including BOXED
WARNING
, is available at
www.gilead.com.

Harvoni and Sovaldi are 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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