-- Results Presented at The International
Liver Congress™ 2017 Highlight Progress for the Treatment of
Pediatric HCV and Adult HCV/HBV Co-Infected Patient Populations
--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results
from two Phase 2 studies evaluating Harvoni® (ledipasvir 90
mg/sofosbuvir 400 mg, LDV/SOF) tablets in chronic hepatitis C virus
(HCV)-infected patient populations not previously studied in
dedicated clinical trials with direct-acting antiviral therapies.
The studies demonstrated HCV cure rates of 99 percent in children
aged 6 to 11 years (#PS-101), and 100 percent in adult patients
co-infected with HCV and hepatitis B virus (HBV) (#PS-098).
Detailed results from these studies were presented this week at The
International Liver CongressTM 2017 in Amsterdam.
Harvoni is approved in the United States for the treatment of
genotype 1, 4, 5, or 6 chronic HCV infection in adults and
pediatric patients 12 years of age or older or weighing at least 35
kilograms. Harvoni is indicated with ribavirin (RBV) for the
treatment of chronic HCV genotype 1 or 4 HCV infection in liver
transplant recipients without cirrhosis or with compensated
cirrhosis and for genotype 1 HCV-infected patients with
decompensated cirrhosis.
Harvoni has a boxed warning in its product label regarding the
risk of hepatitis B virus reactivation in HCV/HBV co-infected
patients. See below for important safety information.
“Gilead continues to study the safety and efficacy of our
medicines in HCV-infected patients with unmet medical need, to help
realize the potential for cure,” said Norbert Bischofberger, PhD,
Executive Vice President of Research and Development and Chief
Scientific Officer, Gilead Sciences. “In these studies of younger
children with hepatitis C and HCV/HBV co-infected patients, Harvoni
achieved high cure rates and demonstrated safety consistent with
the known profile of the drug.”
Children Aged 6 to 11 Years with
Chronic HCV
The estimated prevalence of HCV infection in children is up to
0.4 percent in Europe and the United States and up to 6 percent in
resource-limited countries. For children 6-11 years of age weighing
less than 35 kilograms, interferon plus RBV for up to 48 weeks
remains the standard of care.
Results from an open-label Phase 2 study, led by Karen F.
Murray, MD, Professor of Pediatrics at Seattle Children’s Hospital
in Seattle, Washington, evaluating an investigational dosage
strength of a once-daily single tablet of Harvoni (ledipasvir 45
mg/sofosbuvir 200 mg) in HCV-infected children aged 6 to 11 years,
demonstrated cure rates of 99 percent (n=89/90). Genotype 1
patients received 12 weeks of treatment (n=85); one genotype 1
patient who had cirrhosis and prior treatment failure with
pegylated interferon plus RBV received 24 weeks of treatment;
genotype 3 patients (n=2) received Harvoni plus RBV for 24 weeks;
genotype 4 patients (n=2) received Harvoni for 12 weeks. One
treatment-naïve genotype 1 patient relapsed; all other patients
achieved SVR12, the primary efficacy endpoint. The most common
adverse events (>10 percent) all of which were mild to moderate
in severity, were abdominal pain, headache, diarrhea, vomiting,
nausea, fatigue, pyrexia, cough and oropharyngeal pain. No patients
discontinued therapy.
HCV/HBV Co-infected
Patients
The global prevalence of HCV/HBV co-infection is estimated to be
1.7–3.9 million. Reactivation of HBV infection during treatment of
HCV infection with direct-acting antiviral agents has been reported
in the postmarketing setting. However, clinical trials to more
systematically assess the safety and efficacy of direct-acting
antiviral therapy in HCV/HBV co-infected patients with active HBV
infection have not been conducted.
This Phase 2, open-label study led by Chun-Jen Liu, Professor of
Medicine at National Taiwan University in Taipei, Taiwan, evaluated
12 weeks of Harvoni in 111 genotype 1 or 2 HCV-infected patients in
Taiwan with active HBV co-infection (hepatitis B surface antigen
positive), who were not receiving HBV treatment. All patients
achieved SVR12 (100 percent, 111/111) including 68 genotype 1
HCV-infected patients, 43 genotype 2 HCV-infected patients, 17
patients with compensated cirrhosis and 37 with prior HCV treatment
failure.
Three patients had serious adverse events that were not
considered to be drug-related, including optic neuritis,
post-procedural bleeding and duodenal ulcer bleeding. The most
common adverse events reported (≥5 percent of patients) were
headache, upper respiratory infection and fatigue.
Of the 111 patients enrolled, 23 (21 percent) experienced an
increase in HBV DNA of at least 2 log10 IU/mL during or following
Harvoni treatment. However, no patient experienced a grade 3 or 4
ALT increase or any clinical manifestations suggestive of HBV
reactivation. There were two patients that started HBV treatment
based on increases in HBV DNA and mild elevations in ALT without
symptoms.
Further information about the clinical studies described above
can be found at www.clinicaltrials.gov.
Certain uses for Harvoni highlighted above are investigational
and have not been determined to be safe or efficacious.
U.S. Important Safety Information for
Harvoni
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN
HBV/HCV 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.
- Related Products Not
Recommended: Harvoni is not recommended for use with other
products containing sofosbuvir.
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.
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 in special 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.
U.S. full prescribing information for Harvoni,
including BOXED WARNING, is available at www.gilead.com.
Harvoni is a registered trademark 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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Gilead Sciences, Inc.Sung Lee, 650-524-7792 (Investors)Mark
Snyder, 650-522-6167 (Media)
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