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– 96 Percent SVR12 Rate for Hepatitis C Genotypes 1 and 4 Among
HIV-infected Patients on Antiretroviral Therapy –
SEATTLE--(BUSINESS WIRE)--Feb. 26, 2015--
Gilead Sciences, Inc. (NASDAQ:GILD) today announced results from a Phase
3 study, ION-4, evaluating the once-daily single tablet regimen Harvoni®
(ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of genotypes 1 or
4 chronic hepatitis C virus (HCV) infection among patients co-infected
with HIV. In the trial, 96 percent (n=321/335) of HCV patients achieved
a sustained virologic response 12 weeks after completing therapy
(SVR12). Patients who achieve SVR12 are considered cured of HCV
infection. These data were presented in a late-breaker oral session
(Session 152LB) at the 22nd Conference on Retroviruses and
Opportunistic Infections (CROI) in Seattle.
“This trial provides strong evidence that people who are co-infected
with HIV can achieve very high rates of hepatitis C cure with a
combination direct-acting antiviral regimen,” said Susanna Naggie, MD,
MHS, Director of Infectious Diseases Research at Duke Clinical Research
Institute and Principal Investigator for the ION-4 study. “These high
cure rates were observed in most of the historically difficult-to-treat
sub-populations, including those who failed previous treatment and those
with cirrhosis. We are greatly encouraged by these findings.”
ION-4 is a Phase 3, multicenter, open-label study investigating the
efficacy, safety and tolerability of Harvoni treatment for 12 weeks in
335 patients with HCV genotype 1a (75 percent), 1b (23 percent) or 4 (2
percent) and HIV-1 co-infection. The study included HCV treatment-naïve
(45 percent) and treatment-experienced (55 percent) patients, including
patients with compensated cirrhosis (20 percent), whose HIV was
suppressed using one of three HIV antiretroviral (ARV) regimens:
tenofovir and emtricitabine with efavirenz (Atripla®),
raltegravir or rilpivirine (Complera®).
SVR12 rates did not differ significantly by prior HCV treatment status,
presence or absence of cirrhosis, or ARV regimen. No patients
discontinued Harvoni due to an adverse event (AE). Of the 14 patients
that did not achieve SVR12, two patients experienced virologic failure
during treatment (likely due to non-compliance per physician reporting),
10 experienced virologic relapse post-treatment, one was lost to follow
up and one died due to causes unrelated to study drug. The most common
AEs reported were headache (25 percent), fatigue (21 percent) and
diarrhea (11 percent).
Harvoni received regulatory approval for the treatment of chronic HCV
genotype 1 infection in adults in the United States in October 2014.
Based on the ION-4 trial results, Gilead plans to file a supplemental
New Drug Application with the U.S. Food and Drug Administration for
Harvoni to include the results from this study in the U.S. label.
Harvoni received marketing authorization in Europe in November 2014,
where data from a small study in HIV-HCV co-infected patients
(ERADICATE) are included in the prescribing information.
Important Safety Information for Harvoni
Warnings and Precautions
Most common (≥10%, all grades) adverse reactions were fatigue and
Additionally, patients taking Harvoni concomitantly with the combination
of efavirenz, emtricitabine and tenofovir disoproxil fumarate should be
monitored for tenofovir-associated adverse events.
Consult the full Prescribing Information for Harvoni for more
information on potentially significant drug interactions, including
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.
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 the supplemental New Drug Application may not be approved. In
addition, physicians and patients may not see advantages of Harvoni over
other therapies and physicians may therefore be reluctant to prescribe
the product and private and public payers may be reluctant to provide
coverage or reimbursement for the product. Further, additional studies
of Harvoni may produce unfavorable results. 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, 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.
U.S. full Prescribing Information for Harvoni and U.S. full
Prescribing Information, including BOXED WARNING, for Atripla and
Complera are available at www.gilead.com.
Atripla is a registered trademark of Bristol-Myers Squibb & Gilead
Complera and Harvoni 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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Patrick O’Brien, 650-522-1936 (Investors)Cara
Miller, 650-522-1616 (Media)