– Women in Biktarvy Treatment Arm Maintained High Rates of
Virologic Suppression With No Adverse-Event Discontinuations and No
Treatment-Emergent Resistance Through 48 Weeks –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 5, 2018--
Gilead Sciences, Inc. (NASDAQ: GILD) today announced 48-week results
from a Phase 3 study (Study 1961) of 470 virologically suppressed adult
women with HIV infection, evaluating the efficacy and safety of
switching from a boosted protease inhibitor (bPI) or boosted
elvitegravir-containing regimen to Biktarvy® (bictegravir
50mg/emtricitabine 200mg/tenofovir alafenamide 25mg), a once-daily
single tablet regimen. In the ongoing study, Biktarvy was found to be
statistically non-inferior to regimens containing a bPI or boosted
elvitegravir and demonstrated no treatment-emergent resistance at 48
weeks. The data were presented at the International Workshop on HIV and
Women and at the 2018 Conference on Retroviruses and Opportunistic
Infections (CROI) in Boston (Poster 2539).
“In this study, women who switched to Biktarvy maintained high levels of
viral suppression, comparable to those who remained on a baseline
regimen of either Genvoya®, Stribild® or
ATV+RTV+FTC/TDF, and none of the participants on Biktarvy developed
treatment-emergent resistance,” said Cissy Kityo, MD, Deputy Executive
Director of Joint Clinical Research Centre, Kampala, Uganda and lead
investigator on the study. “Conducting this women-only study on an
international scale helps to further demonstrate that Biktarvy may be
appropriate for a wide range of people living with HIV.”
Biktarvy is indicated as a complete regimen for the treatment of HIV-1
infection in adults who have no antiretroviral treatment history or to
replace the current antiretroviral regimen in those who are
virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral
regimen for at least three months with no history of treatment failure
and no known substitutions associated with resistance to the individual
components of Biktarvy. No dosage adjustment of Biktarvy is required in
patients with estimated creatinine clearance greater than or equal to 30
mL per minute. Biktarvy has a Boxed Warning in its product label
regarding the risk of post treatment acute exacerbation of hepatitis B.
See below for Important Safety Information.
In Study 1961, a total of 470 virologically suppressed adult women
taking a regimen of atazanavir (ATV) + ritonavir (RTV) +
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), Stribild (elvitegravir
150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir disoproxil fumarate
300mg) or Genvoya (elvitegravir 150mg/cobicistat 150mg/emtricitabine
200mg/tenofovir alafenamide 10mg) were randomized 1:1 to switch to
open-label Biktarvy or stay on their baseline regimen (SBR). At Week 48,
the primary endpoint of the study, switching to Biktarvy was
non-inferior to continuing an SBR with 1.7 percent of participants in
both the Biktarvy and the SBR arms having HIV-1 RNA ≥50 c/mL (difference
0.0 percent; 95 percent CI: -2.9 percent to 2.9 percent, p=1.00); the
proportion of patients with HIV-1 RNA <50 c/mL was 95.7 percent in the
Biktarvy arm and 95.3 percent in the SBR arm, according to FDA snapshot
No patients in the Biktarvy treatment arm developed treatment-emergent
resistance, while one patient taking Genvoya in the SBR arm developed an
emergent M184M/I/V mutation. No renal adverse events leading to
discontinuations and no cases of proximal renal tubulopathy occurred in
either arm. The most commonly reported adverse events (all grades) in
both arms included nasopharyngitis, upper respiratory tract infection,
headache, vulvovaginal candidiasis and urinary tract infection. No
patient in either treatment group discontinued the study due to an
Demographic and baseline characteristics of the study participants were
balanced with 37 percent Black, 28 percent white, 22 percent Asian and
16 percent Hispanic or Latina, a median age of 39 years and a median CD4
count of 686 cells/µL. Participants were recruited in the Dominican
Republic, Russia, Thailand, Uganda and the United States.
“Gilead is committed to researching and developing treatments that have
the potential to be used in a broad range of patients, including women
who have traditionally been underrepresented in HIV clinical trials,”
said Norbert Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences. “This study
demonstrates that Biktarvy offers a safety and efficacy profile that may
help to care for women living with HIV.”
Additional clinical trials of Biktarvy are ongoing, including a study in
adolescents and children living with HIV. Biktarvy is only approved for
use in adults.
Biktarvy was approved by the United States Food and Drug Administration
(FDA) on February 7, 2018. A marketing authorization application for
Biktarvy is under review in the European Union.
Biktarvy does not cure HIV infection or AIDS.
Further information about the clinical study can be found at www.clinicaltrials.gov.
Important U.S. Safety Information for Biktarvy
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Severe acute exacerbations of hepatitis B have been reported in
patients who are coinfected with HIV-1 and HBV and have discontinued
products containing emtricitabine (FTC) and/or tenofovir disoproxil
fumarate (TDF), and may occur with discontinuation of Biktarvy.
Closely monitor hepatic function with both clinical and laboratory
follow-up for at least several months in patients who are coinfected
with HIV-1 and HBV and discontinue Biktarvy. If appropriate,
anti-hepatitis B therapy may be warranted.
Coadministration: Do not use Biktarvy with dofetilide or
Warnings and precautions
Drug interactions: See Contraindications and Drug Interactions
sections. Consider the potential for drug interactions prior to and
during Biktarvy therapy and monitor for adverse reactions.
Immune reconstitution syndrome, including the occurrence of
autoimmune disorders with variable time to onset, has been reported.
New onset or worsening renal impairment: Cases of acute renal
failure and Fanconi syndrome have been reported with the use of
tenofovir prodrugs. In clinical trials of Biktarvy, there have been no
cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not
initiate Biktarvy in patients with estimated creatinine clearance
(CrCl) <30 mL/min. Patients with impaired renal function and/or taking
nephrotoxic agents (including NSAIDs) are at increased risk of
renal-related adverse reactions. Discontinue Biktarvy in patients who
develop clinically significant decreases in renal function or evidence
of Fanconi syndrome.
Renal monitoring: Prior to or when
initiating Biktarvy and during therapy, assess serum creatinine, CrCl,
urine glucose, and urine protein in all patients as clinically
appropriate. In patients with chronic kidney disease, also assess
Lactic acidosis and severe hepatomegaly with steatosis: Fatal
cases have been reported with the use of nucleoside analogs, including
FTC and TDF. Discontinue Biktarvy if clinical or laboratory findings
suggestive of lactic acidosis or pronounced hepatotoxicity develop,
including hepatomegaly and steatosis in the absence of marked
Most common adverse reactions (incidence ≥5%; all grades) in
clinical studies were diarrhea (6%), nausea (5%), and headache (5%).
Prescribing information: Consult the full prescribing
information for Biktarvy for more information on Contraindications,
Warnings, and potentially significant drug interactions, including
Enzymes/transporters: Drugs that induce P-gp or induce both
CYP3A and UGT1A1 can substantially decrease the concentration of
components of Biktarvy. Drugs that inhibit P-gp, BCRP, or inhibit both
CYP3A and UGT1A1 may significantly increase the concentrations of
components of Biktarvy. Biktarvy can increase the concentration of
drugs that are substrates of OCT2 or MATE1.
Drugs affecting renal function: Coadministration of Biktarvy
with drugs that reduce renal function or compete for active tubular
secretion may increase concentrations of FTC and tenofovir and the
risk of adverse reactions.
Dosage and administration
Dosage: 1 tablet taken once daily with or without food.
Renal impairment: Not recommended in patients with CrCl <30
Hepatic impairment: Not recommended in patients with severe
Prior to or when initiating: Test patients for HBV infection.
Prior to or when initiating, and during treatment: As
clinically appropriate, assess serum creatinine, CrCl, urine glucose,
and urine protein in all patients. In patients with chronic kidney
disease, assess serum phosphorus.
Pregnancy and lactation
Pregnancy: There is insufficient human data on the use of
Biktarvy during pregnancy. An Antiretroviral Pregnancy Registry (APR)
has been established. Available data from the APR for FTC shows no
difference in the rates of birth defects compared with a US reference
Lactation: Women infected with HIV-1 should be instructed not
to breastfeed, due to the potential for HIV-1 transmission.
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 35
countries worldwide, with headquarters in Foster City, California.
For nearly 30 years, Gilead has been a leading innovator in the field of
HIV, driving advances in treatment, prevention, testing and linkage to
care, and cure research. Today, it’s estimated that more than 10 million
people living with HIV globally receive antiretroviral therapy provided
by Gilead or one of the company’s manufacturing partners.
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 Biktarvy. In
addition, the European Union and other regulatory authorities may not
approve Biktarvy in the currently anticipated timelines or at all, and
any marketing approvals, if granted, may have significant limitations on
their use. 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, 2017, 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 Biktarvy, Stribild and Genvoya,
including BOXED WARNINGS, are available at www.gilead.com.
Biktarvy, Stribild and Genvoya are 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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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792