– Biktarvy Showed High Efficacy and High Barrier to Resistance
Through 96 Weeks –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 30, 2018--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced 96-week results
from a Phase 3, randomized, double-blinded study (Study 1490) evaluating
the safety and efficacy of Biktarvy® (bictegravir 50
mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets,
BIC/FTC/TAF) for the treatment of HIV-1 infection in treatment-naïve
adults. In the ongoing study, Biktarvy was found to be statistically
non-inferior to a regimen of dolutegravir and emtricitabine/tenofovir
alafenamide (50 mg) (DTG+FTC/TAF) through 96 weeks of therapy. The data
were presented during a late-breaking abstract session at the 2018 HIV
Glasgow conference in Glasgow, Scotland, UK.
“This study demonstrated the high efficacy, high barrier to resistance
and long-term tolerability profile of Biktarvy through 96 weeks,
reaffirming its role as a first-line treatment option for appropriate
adult HIV patients who are starting therapy,” said Hans-Jürgen
Stellbrink, MD, PhD, Professor of Internal Medicine, Infectious
Diseases, at the University of Hamburg, Germany and lead study author.
“Biktarvy was also shown to have few discontinuations due to adverse
events through 96 weeks, which may be an important consideration for
health care providers making clinical care decisions.”
Biktarvy is indicated in the U.S. 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 adults 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. Biktarvy carries a
Boxed Warning in its U.S. product label regarding the risk of
post-treatment acute exacerbation of hepatitis B. See below for
Important Safety Information.
In Study 1490, treatment-naïve adults (n=645) were randomized 1:1 in a
blinded fashion to receive Biktarvy or DTG+FTC/TAF. At Week 96,
non-inferiority was maintained from the primary endpoint measurement at
Week 48, with 84.1 percent (n=269/320) of patients taking Biktarvy and
86.5 percent (n=281/325) of patients taking DTG+FTC/TAF achieving HIV-1
RNA levels less than 50 copies/mL (difference: -2.3 percent, 95 percent
CI: -7.9 percent to 3.2 percent, p=0.41). In the resistance analysis
population, none of the study participants randomized to Biktarvy
developed treatment-emergent resistance.
Biktarvy was well-tolerated with low discontinuations due to adverse
events in both treatment arms (2 percent (n=6) for Biktarvy vs. 2
percent (n=5) for DTG+FTC/TAF [1 Biktarvy and 4 DTG+FTC/TAF after Week
48]). The most commonly reported adverse events (all grades) were
diarrhea (18 percent for Biktarvy vs. 16 percent for DTG+FTC/TAF) and
headache (16 percent vs. 15 percent). There were fewer treatment-related
adverse events (all grades) in the Biktarvy arm compared to DTG+FTC/TAF
(20 percent for Biktarvy vs. 28 percent for DTG+FTC/TAF). Lipid changes
were not significantly different between the two arms, and there were no
renal discontinuations or cases of proximal renal tubulopathy.
“These data presented at HIV Glasgow further demonstrate the efficacy
and tolerability profile of Biktarvy, supporting the use of this
once-daily single tablet regimen in a broad range of adults living with
HIV who are new to HIV therapy,” said John McHutchison, AO, MD, Chief
Scientific Officer, Gilead Sciences. “Gilead is working to advance
access to Biktarvy to appropriate patients around the world as we
continue our clinical and research efforts focusing on novel mechanisms
of action for next-generation HIV treatments and, ultimately, a cure.”
Additional clinical trials of Biktarvy are ongoing, including dedicated
studies in older adult women, African-American people living with HIV,
adolescents and children living with HIV, as well as an additional study
in treatment-naïve HIV-1 infected adults (Study 1489). Data from an
analysis of pooled treatment-naïve adults in Studies 1489 and 1490 with
high viral loads (HIV-1 RNA > 100,000 c/mL) or low CD4 counts (CD4 < 200
cells/µL) are also being presented in a poster session at HIV Glasgow.
Biktarvy is only approved for use in adults.
Study 1490 is ongoing and will remain randomized and blinded through 144
Biktarvy is approved in Australia, Canada, the European Union, Hong Kong
and the United States.
Biktarvy does not cure HIV infection or AIDS.
IMPORTANT U.S. SAFETY INFORMATION AND
INDICATION 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.
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.
Dosage and administration
Dosage: 1 tablet taken once daily with or without food.
Renal impairment: Not recommended in patients with CrCl
Hepatic impairment: Not recommended in patients with
severe hepatic impairment.
Prior to or when initiating: Test patients for HBV
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.
Biktarvy is indicated as a complete regimen for the treatment of HIV-1
infection in adults who have no antiretroviral (ARV) treatment history
or to replace the current ARV regimen in those who are virologically
suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen for ≥3
months with no history of treatment failure and no known resistance to
any component of Biktarvy.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that
discovers, develops and commercializes innovative medicines in areas of
unmet medical need. The company strives to transform and simplify care
for people with life-threatening illnesses around the world. Gilead has
operations in more than 35 countries worldwide, with headquarters in
Foster City, California. For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com.
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 for the
treatment of HIV-1 infection 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 10-Q for the quarter ended June 30, 2018, 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
U.S. full prescribing information for Biktarvy, including BOXED
WARNING, is available at www.gilead.com
Biktarvy, Gilead and the Gilead logo 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