The information in this section is intended for visitors outside the United States.
-- European Commission Also Approves Expanded Indication for
Regimen, Marketed as Eviplera® in the European
FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 13, 2013--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food
and Drug Administration (FDA) has approved the single tablet HIV-1
regimen Complera® (emtricitabine/rilpivirine/tenofovir
disoproxil fumarate) for use in certain virologically-suppressed (HIV
RNA <50 copies/mL) adult patients on a stable antiretroviral regimen in
order to replace their current antiretroviral treatment regimen.
Complera was first approved in 2011 for patients new to therapy and is
now one of the most widely-prescribed HIV regimens in the United States.
“Complera is an effective single-pill therapy with a demonstrated safety
profile, and has rapidly become an important option for appropriate HIV
patients who are initiating antiretroviral treatment,” said Calvin J.
Cohen, MD, M.Sc., Research Director, Community Research Initiative of
New England and an investigator on clinical trials of Complera. “The
data supporting today’s approval demonstrate Complera has the potential
to help a broader range of HIV-infected patients who have achieved
virologic control on another regimen.”
Complera combines a complete course of three antiretroviral medications
into a single, once-daily tablet. The product contains Gilead’s Truvada®,
which itself is a fixed-dose combination of two HIV medicines, and
Janssen R&D Ireland’s rilpivirine (marketed as Edurant®).
Patients switching to Complera should have no history of virologic
failure, have suppressed viral load for at least six months, be on their
first or second antiretroviral regimen, and have no current or past
history of resistance to Complera components. The efficacy of Complera
was established in patients who were virologically suppressed (HIV RNA
<50 copies/mL) on a stable ritonavir-boosted protease
Today’s approval is supported by clinical data from the Phase 3 SPIRIT
(Study 106) clinical trial. In this randomized, open-label study,
virologically suppressed patients who were taking multi-tablet HIV
therapy containing a ritonavir-boosted protease inhibitor (PI) either
switched to Complera or remained on their PI-based regimen. The study
found that, after 48 weeks of treatment with Complera, 89 percent
(n=283/317) of switch patients had viral load less than 50 copies/mL,
compared to 90 percent (143/159) of patients who remained on a
PI-regimen for 24 weeks. Complera was well tolerated in SPIRIT and there
were few treatment discontinuations due to adverse events. The most
common side effects in previous clinical studies of Complera were
headache, depressive disorders and insomnia (2 percent for all). No new
adverse reactions were identified in SPIRIT, but the frequency of
adverse reactions increased from 2 percent to 2.4 percent. Complera has
a labeled Boxed Warning on the risks of lactic acidosis/severe
hepatotoxicity with steatosis and acute exacerbation of hepatitis B; see
below for Important Safety Information.
Marketed as Eviplera® (emtricitabine/rilpivirine/tenofovir
disoproxil (as fumarate)) in the European Union, the regimen also was
recently granted European regulatory approval for any HIV-infected adult
patients without known mutations associated with resistance to the
non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir
or emtricitabine, and with a viral load ≤ 100,000 HIV-1 RNA copies/mL.
Important Safety Information about Complera
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and
POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been reported with the use of nucleoside analogs,
including tenofovir disoproxil fumarate (tenofovir DF), a component of
COMPLERA, in combination with other antiretrovirals.
COMPLERA is not approved for the treatment of chronic hepatitis B
virus (HBV) infection and the safety and efficacy of COMPLERA have not
been established in patients coinfected with HBV and HIV-1. Severe acute
exacerbations of hepatitis B have been reported in patients who are
coinfected with HBV and HIV-1 and have discontinued emtricitabine or
tenofovir DF, which are components of COMPLERA. Hepatic function should
be monitored closely with both clinical and laboratory follow-up for at
least several months in patients who are coinfected with HIV-1 and HBV
and discontinue COMPLERA. If appropriate, initiation of anti-hepatitis B
therapy may be warranted.
WARNINGS AND PRECAUTIONS
Pregnancy and Breastfeeding
DOSAGE AND ADMINISTRATION
Adults: One tablet taken orally once daily with food.
Renal Impairment: Do not use in patients requiring dose
adjustment or patients with estimated CrCl <50 mL/min.
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
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 healthcare providers in the United States and European Union
may not see advantages of switching virologically suppressed HIV
patients to Complera/Eviplera and may therefore be reluctant to
prescribe the product. 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 statements..
U.S. full prescribing information for Complera and Truvada, including BOXED
WARNING for both products, is available at www.Gilead.com.
EU Summaries of Product Characteristics for Eviplera and Truvada are
available at http://www.ema.europa.eu.
Complera, Eviplera, and Truvada are registered trademarks of Gilead
Sciences, Inc., or its related companies.
Edurant is a registered trademark of Janssen R&D Ireland.
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)Arran Attridge, +44 (208) 587-2477