Gilead Sciences, Inc. (NASDAQ: GILD) today presented findings
from two Phase 3 trials – a trial demonstrating the effectiveness
of switching to Biktarvy (bictegravir 50mg/emtricitabine
200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) in women, and a
trial evaluating the potential for the single tablet regimen to be
an effective treatment option in virologically suppressed patients
with known resistance to nucleo(s)tide or non-nucleo(s)tide reverse
transcriptase inhibitors (NRTIs or NNRTIs). The use of Biktarvy in
patients with known drug resistance is investigational. These data
were presented at the 10th International AIDS Society Conference on
HIV Science (IAS 2019) being held in Mexico City.
“These data presented at IAS provide new information about the
treatment of HIV among women and patients with known drug
resistance,” said Diana Brainard, MD, Senior Vice President, HIV
and Emerging Viruses, Gilead Sciences. “The studies further
demonstrate the potential for Biktarvy to be an important treatment
option for appropriate patients.”
In the United States, Biktarvy is indicated as a complete
regimen for the treatment of HIV-1 infection in adults or pediatric
patients weighing at least 25 kg who have no antiretroviral
treatment history. While Biktarvy is also indicated for adults and
pediatric patients weighing at least 25 kg who are virologically
suppressed and on a stable antiretroviral regimen, these patients
must have no history of treatment failure and no known
substitutions associated with resistance to the individual
components of Biktarvy. On June 18, 2019, the U.S. Food and Drug
Administration (FDA) approved labeling revisions to Biktarvy,
expanding the patient population to include HIV-1 infected
pediatric patients weighing at least 25 kg. Biktarvy has 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.
Key abstracts for Biktarvy data presented at IAS 2019
include:
Oral Presentation MOAB0106: Longer-term (96-week) efficacy
and safety of switching to bictegravir/emtricitabine/tenofovir
alafenamide (B/F/TAF) in women
This international multicenter, randomized, open-label Phase 3
trial evaluated 470 virologically suppressed women on a baseline
regimen of either Genvoya® (elvitegravir/cobicistat/F/TAF;
150/150/200/10 mg), elvitegravir/cobicistat/F/TDF (150/150/200/300
mg) or atazanavir+ritonavir+F/TDF (300+100+200/300 mg) who switched
1:1 from these baseline regimens to Biktarvy. The primary endpoint
for this study conducted exclusively in women, was previously
presented, and demonstrated noninferior maintained virologic
suppression, with a low frequency of serious adverse events and no
emergent resistance at Week 48. All participants, including those
on baseline regimens, switched to Biktarvy through Week 96.
At Week 96, 99.5 percent of women who received Biktarvy
throughout the study duration and 98.5 percent of women who
switched to Biktarvy at Week 48 maintained virologic suppression
(missing=excluded; M=E), with no development of treatment-emergent
resistance. Biktarvy was also shown to be well-tolerated with low
frequencies of serious adverse events.
“Despite the fact that women account for the majority of new HIV
infections globally, they remain largely underrepresented in HIV
clinical trials,” said Cissy Kityo, MD, Executive Director, Joint
Clinical Research Centre in Uganda, and lead study investigator.
“The findings from this study conducted exclusively in women yield
important long-term data on the safety, tolerability and efficacy
of Biktarvy in this important patient population.”
Oral Presentation MOAB0105: Switching to a single-tablet
regimen bictegravir, emtricitabine, and tenofovir alafenamide
(B/F/TAF) from dolutegravir (DTG) plus emtricitabine and either
tenofovir alafenamide or tenofovir disoproxil fumarate (F/TAF or
F/TDF)
This ongoing, randomized, double-blinded Phase 3 study evaluated
565 virologically suppressed adults who switched 1:1 from a regimen
of DTG+F/TAF (50+200/25 mg) or DTG+F/TDF (50+200/300 mg) to
DTG+F/TAF or Biktarvy for 48 weeks. Unlike previous studies – which
excluded participants with known resistance – participants in this
study with prior resistance to NRTIs, NNRTIs and/or protease
inhibitors (PIs) could enroll. Only those participants with
documented integrase inhibitor resistance were excluded, and 24
percent of participants had resistance to NRTIs. The study’s
primary endpoint was the proportion of participants with HIV-1 RNA
≥ 50 c/ml at Week 48.
At Week 48, 0.4 percent (n=284) of participants on Biktarvy had
HIV-1 RNA ≥ 50 c/ml, compared to 1.1 percent of participants on
DTG+F/TAF (n=281) (snapshot algorithm), demonstrating
noninferiority. In addition, at Week 48, no treatment-emergent
resistance was detected, and no participants with pre-existing NRTI
resistance mutations had HIV RNA >50 c/mL.
The use of Biktarvy in patients with known drug resistance is
investigational and has not been determined to be safe or
efficacious and is not approved by the U.S. FDA.
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.
Contraindications
- Coadministration: Do not use Biktarvy with dofetilide or
rifampin.
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 transaminase elevations.
Adverse reactions
- Most common adverse reactions (incidence ≥5%; all
grades) in clinical studies through week 96 were diarrhea (6%),
nausea (6%), and headache (5%).
Drug interactions
- Prescribing information: Consult the full prescribing
information for Biktarvy for more information on Contraindications,
Warnings, and potentially significant drug interactions, including
clinical comments.
- 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 population.
- 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
<30 mL/min.
- Hepatic impairment: Not recommended in patients with
severe hepatic impairment.
- 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.
INDICATION
Biktarvy is indicated as a complete regimen for the treatment of
HIV-1 infection in adults and pediatric patients weighing at least
25 kg 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
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 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 12 million people living with HIV globally receive
antiretroviral therapy provided by Gilead or one of the company’s
manufacturing partners.
For more information on Gilead Sciences, please visit the
company’s website at www.gilead.com.
Forward-Looking Statement
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 possibility of unfavorable results from ongoing and
additional clinical trials involving Biktarvy. All statements other
than statements of historical fact are statements that could be
deemed forward-looking statements. 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 March 31, 2019, 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
and Genvoya, including BOXED WARNINGS, is available at
www.gilead.com.
Biktarvy, Genvoya, 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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Ryan McKeel, Media (650) 377-3548
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