– In Clinical Trials, Biktarvy Demonstrated High Efficacy, Few
Interactions With Other Drugs and a High Barrier to Resistance Through
48 Weeks –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 7, 2018--
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food
and Drug Administration (FDA) has approved Biktarvy®
(bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg,
BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment
of HIV-1 infection. Biktarvy combines the novel, unboosted integrase
strand transfer inhibitor (INSTI) bictegravir, with the demonstrated
safety and efficacy profile of the Descovy® (FTC/TAF) dual
nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the
smallest INSTI-based triple-therapy STR available.
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 does not require testing for HLA-B*5701, has no food intake
requirements, and has no baseline viral load or CD4 count restrictions.
According to Biktarvy’s Prescribing Information, prior to or when
initiating treatment with Biktarvy, healthcare providers should test for
hepatitis B virus (HBV) infection and renal function, and monitor renal
function as clinically appropriate during therapy.
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.
Photos and a multimedia gallery are available at www.GileadHIVMedia.com.
“In clinical trials through 48 weeks, no patients taking the regimen of
bictegravir plus FTC/TAF developed treatment-emergent resistance,
results that were observed both in people new to therapy and those who
were virologically suppressed and chose to switch regimens,” said Paul
Sax, MD, Clinical Director of the Division of Infectious Diseases at
Brigham and Women’s Hospital, Boston, Professor of Medicine at Harvard
Medical School and a lead clinical trial investigator. “In addition, the
clinical data show that the regimen’s antiviral efficacy, tolerability
profile and limited drug interactions offer an effective new treatment
option for a range of people living with HIV.”
The approval of Biktarvy is supported by data from four ongoing Phase 3
studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults,
and Studies 1844 and 1878 in virologically suppressed adults. The trials
are comprised of a diverse population of 2,415 participants, including a
wide range of adult age groups and races/ethnicities. Biktarvy met its
primary objective of non-inferiority at 48 weeks across all four
studies. Through 48 weeks, no participants in any of the four studies
failed Biktarvy with treatment-emergent virologic resistance, no
patients discontinued Biktarvy due to renal adverse events and there
were no cases of proximal renal tubulopathy or Fanconi syndrome. The
most common adverse reactions in patients taking Biktarvy were diarrhea,
nausea and headache.
In Study 1489, a total of 629 treatment-naïve adults with HIV were
randomized 1:1 to receive Biktarvy or abacavir/dolutegravir/lamivudine
(600/50/300mg) (ABC/DTG/3TC). At Week 48, 92.4 percent (n=290/314) of
patients taking Biktarvy and 93.0 percent (n=293/315) of patients taking
ABC/DTG/3TC achieved the primary endpoint of HIV-1 RNA <50 c/mL. In
Study 1490, a total of 645 treatment-naïve adults with HIV were
randomized 1:1 to receive Biktarvy or DTG+FTC/TAF. At Week 48, 89.4
percent (n=286/320) of patients taking Biktarvy and 92.9 percent
(n=302/325) of patients taking DTG+FTC/TAF achieved the primary endpoint
of HIV-1 RNA <50 c/mL.
In Study 1878, a total of 577 virologically suppressed (HIV-1 RNA <50
c/mL) adults with HIV taking regimens of a boosted protease inhibitor
(bPI; atazanavir or darunavir) plus a dual-NRTI backbone (ABC/3TC or
FTC/tenofovir disoproxil fumarate) were randomized 1:1 to continue their
bPI regimen or to switch to open-label coformulated Biktarvy once daily.
At the primary endpoint of Week 48, switching to Biktarvy was
non-inferior to continuing on a bPI regimen with 1.7 percent of patients
in each group having HIV-1 RNA ≥50 c/mL; the proportion of patients with
HIV-1 RNA <50 c/mL was 92.1 percent in the Biktarvy arm and 88.9 percent
in the bPI arm, according to FDA snapshot algorithm. Results from Study
1844 will be presented at a scientific conference in 2018.
“Gilead is committed to improving care and simplifying therapy for
people living with HIV. We continue to invest in research in
next-generation treatments, including therapies that could potentially
cure HIV patients,” said John F. Milligan, PhD, Gilead’s President and
Chief Executive Officer. “We are pleased to offer Biktarvy, our latest
triple-therapy treatment, which brings together the potency of an
integrase inhibitor with the most-prescribed dual-NRTI backbone in a
once-daily single tablet regimen.”
Additional clinical trials of Biktarvy are ongoing, including a
dedicated study in women, as well as a study in adolescents and children
living with HIV. Gilead plans to present data from these studies at
scientific conferences in 2018.
Biktarvy does not cure HIV infection or AIDS.
Patient Assistance Programs
Gilead’s U.S. Advancing Access® program provides assistance
to appropriate patients in the United States who are uninsured,
underinsured or who need financial assistance to pay for their
medications, including Biktarvy.
The program offers information and assistance for patients, including:
Access to representatives who can provide information related to
coverage and insurance-related questions.
The Advancing Access Copay Coupon Program, which provides co-pay
assistance for eligible patients with private insurance who need
assistance paying for out-of-pocket medication costs.
The Advancing Access Patient Assistance Program and Truvada for PrEP®
Medication Assistance Program, which will provide Gilead medications
at no charge for eligible patients with no other insurance options.
Additionally, Gilead is working closely with the ADAP Crisis Task Force,
as the company has done for each of its other HIV medications, to
provide discounts to state AIDS Drug Assistance Programs (ADAPs) that
will help ensure access to Biktarvy for patients who receive medications
through these programs.
Information about how to apply for any of these forms of assistance can
be found at www.GileadAdvancingAccess.com
or by calling 1-800-226-2056 Monday through Friday between 9:00 a.m. and
8:00 p.m. EST.
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 serum phosphorus.
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 and the
possibility of unfavorable results from additional clinical trials
involving Biktarvy. 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 10Q for the quarter ended
September 30, 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, including BOXED WARNING,
for Biktarvy is available at www.gilead.com.
Biktarvy, Descovy, Advancing Access, Truvada, Truvada for PrEP, Gilead
and the Gilead logo are trademarks of Gilead Sciences, Inc. or its
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