Phase 3 Studies —
Treatment-Naïve Patients —
Genotype 1 Hepatitis C —
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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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.
“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.”
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).
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.
“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.”
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
U.S. Patient Support Program
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:
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
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
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
IMPORTANT SAFETY INFORMATION
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 (Sovaldi).
Most common (≥10%, all grades) adverse
reactions were fatigue and headache.
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
About Gilead Sciences
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
available at www.gilead.com.
trademarks of Gilead Sciences, Inc., or its related companies.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, Investors, 650-522-1936
Miller, Media, 650-522-1616
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