Gilead Sciences, Inc. (NASDAQ: GILD) today announced that new
data from the company’s HIV research and development programs will
be presented at the 10th International AIDS Society Conference on
HIV Science (IAS 2019) being held in Mexico City from July 21-24.
Fifteen abstracts, along with community-focused symposia and
workshops, reflect Gilead’s ongoing commitment to scientific
innovation, a key pillar to addressing unmet and evolving medical
needs in HIV.
“Gilead’s scientific discovery has helped transform both HIV
treatment and prevention and we are committed to advancing the next
generation of therapies to improve the care of people and
communities impacted by this disease,” said John McHutchison, AO,
MD, Chief Scientific Officer, Head of Research & Development,
Gilead Sciences. “Our data at this year’s meeting include exciting
progress in our HIV prevention, treatment and cure programs, which
together are helping to advance the field of HIV toward the
ultimate goal of ending the epidemic.”
Data from Gilead’s HIV research and development program to be
presented at the meeting include two late-breaking presentations.
The first late-breaker presentation will share additional results
from the DISCOVER trial, evaluating Descovy® (emtricitabine 200 mg
and tenofovir alafenamide 25 mg tablets; F/TAF) for HIV
pre-exposure prophylaxis (PrEP). Descovy was approved for the
treatment of HIV infection in combination with other agents in
2016. The use of Descovy for HIV prevention is investigational.
Gilead submitted a supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA) in early April for
once-daily Descovy for PrEP™, with a target FDA action date
anticipated six months thereafter.
The second late-breaking presentation includes the latest
findings on the potential role of GS-6207, a novel, investigational
HIV-1 capsid inhibitor. In late May, FDA granted Breakthrough
Therapy Designation for the development of GS-6207 for the
treatment of HIV-1 infection in heavily treatment experienced
patients with multi-drug resistance.
In addition, new safety and efficacy data on Biktarvy®
(bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25
mg; B/F/TAF) in virologically suppressed patients and women will be
presented, along with ongoing research on agents that may one day
play a role in an HIV cure strategy. On June 20, FDA approved
labeling revisions to Biktarvy to expand the patient population to
include HIV-1 infected pediatric patients weighing at least 25
kg.
Select Gilead HIV clinical development program data to be
presented at IAS 2019:
HIV prevention
- DISCOVER STUDY for HIV Pre-Exposure Prophylaxis (PrEP): F/TAF
has a More Rapid Onset and Longer Sustained Duration of HIV
Protection Compared with F/TDF [TUAC0403LB; Oral Presentation – Hot
off the press: What’s new in HIV prevention; Tuesday, July 23,
16:30 – 18:00; Palacio de Valparaíso 2]
- A Pooled Analysis of the Effect of Adherence on the Renal
Safety of FTC/TDF (Truvada) for PrEP: 7 International Demonstration
Projects [TUPEC393; Poster Exhibition – Track C; Sala B]
Investigational long-acting therapy
- Safety and Antiviral Activity Over 10 Days Following a Single
Dose of Subcutaneous GS-6207, a First-in-Class, Long-Acting HIV
Capsid Inhibitor in People Living with HIV [LBPEB13; Poster
Exhibition – Track B; Sala B]
- In Vitro Resistance Profile of GS-6207, a First-in-Class
Picomolar HIV Capsid Inhibitor in Clinical Development as a Novel
Long-Acting Antiretroviral Agent [TUPEA075; Poster Exhibition –
Track A; Sala B]
HIV treatment
- 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)
[MOAB0105; Oral Presentation – ART: Trials and tribulations;
Monday, July 22, 11:00 – 12:30; Sala A]
- Longer-Term (96-week) Efficacy and Safety of Switching to
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Women
[MOAB0106; Oral Presentation – ART: Trials and tribulations;
Monday, July 22, 11:00 – 12:30; Sala A]
HIV cure strategy research
- Vesatolimod (GS-9620) is Safe and Pharmacodynamically Active in
HIV-Infected Individuals [WEAA0304; Oral Presentation – Mission
remission: Challenge accepted; Wednesday, July 24, 16:30 – 18:00;
Palacio de Valparaíso 1]
- Oral TLR7 Agonist Administration Induces an Immunostimulatory
Response in SIV-Infected ART-Suppressed Infant Rhesus Macaques
[WEAA0105; Oral Presentation – Paediatric HIV infection: It’s never
too early; Wednesday, July 24, 11:00 – 12:30; Palacio de Iturbide 1
y 2]
For more information, including a complete list of abstract
titles at the meeting, please visit:
http://programme.ias2019.org/Abstract.
The use of Descovy for the prevention of HIV is investigational
and has not been determined to be safe or efficacious and is not
approved anywhere globally.
GS-6207, GS-9620 and GS-968 are investigational compounds and
are not approved by the U.S. Food and Drug Administration or any
other regulatory authority. Their safety and efficacy have not been
established.
Neither Biktarvy nor Descovy cures HIV infection or AIDS.
Gilead’s efforts to address barriers to HIV care
Beyond presenting scientific data from the company’s HIV
research and development program, Gilead will convene discussions
about the barriers that can influence engagement in HIV care on
individual, systemic and community levels. New programs and
strategies are needed to assess and address the barriers to care
that can prevent people and communities impacted by HIV from
accessing care. These Gilead-supported sessions are part of the
company’s ongoing efforts to changing the future of the epidemic
through supporting the development and delivery of practical
solutions towards better care for those people living with or at
risk for HIV.
IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR
DESCOVY
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS
B
- Descovy is not approved for the treatment of chronic
hepatitis B virus (HBV) infection and the safety and efficacy of
Descovy have not been established in patients coinfected with HIV-1
and HBV. 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 Descovy. 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 Descovy. If appropriate, initiation of
anti-hepatitis B therapy may be warranted.
Warnings and precautions
- 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 FTC and tenofovir
alafenamide with elvitegravir and cobicistat, there have been no
cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do
not initiate Descovy 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
Descovy in patients who develop clinically significant decreases in
renal function or evidence of Fanconi syndrome. Renal monitoring:
In all patients, monitor CrCl, urine glucose, and urine protein
prior to initiating and during therapy. In patients with chronic
kidney disease, additionally monitor 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 Descovy 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 reaction (incidence ≥10%; all grades) in
clinical studies was nausea (10%).
Drug interactions
- Prescribing information: Consult the full prescribing
information for Descovy for more information on potentially
significant drug interactions, including clinical comments.
- Metabolism: Drugs that inhibit P-gp can increase the
concentrations of components of Descovy. Drugs that induce P-gp can
decrease the concentrations of components of Descovy, which may
lead to loss of efficacy and development of resistance.
- Drugs affecting renal function: Coadministration of Descovy
with drugs that reduce renal function or compete for active tubular
secretion may increase concentrations of emtricitabine and
tenofovir and the risk of adverse reactions.
Dosage and administration
- Dosage: Patients who weigh ≥25 kg: 1 tablet taken orally once
daily with or without food.
- Renal impairment: Not recommended in patients with CrCl <30
mL/min.
- Testing prior to initiation: Test patients for HBV infection
and assess CrCl, urine glucose and urine protein.
- Pediatrics: The safety and effectiveness of Descovy
coadminstered with an HIV-1 protease inhibitor that is administered
with either ritonavir or cobicistat have not been established in
pediatric subjects weighing less than 35 kg.
Pregnancy and lactation
- Pregnancy: There is insufficient human data on the use of
Descovy 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
U.S. reference population.
- Lactation: Women infected with HIV-1 should be instructed not
to breastfeed, due to the potential for HIV-1 transmission.
INDICATION
Descovy is indicated in combination with other antiretroviral
(ARV) agents for the treatment of HIV-1 infection in patients
weighing at least 35 kg.
Descovy is also indicated, in combination with other
antiretroviral agents other than protease inhibitors that require a
CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric
patients weighing at least 25 kg and less than 35 kg.
Limitations of Use:
Descovy is not indicated for use as pre-exposure prophylaxis
(PrEP) to reduce the risk of acquiring HIV-1 infection.
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
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 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 risk that the sNDA for Descovy for PrEP may not get
approved by FDA or other regulatory authorities in the currently
anticipated timelines or at all, and any marketing approvals, if
granted, may have significant limitations on its use. In addition,
there is the possibility of unfavorable results from other ongoing
and additional clinical trials involving GS-6207, GS-9620 and
GS-968. As a result, Descovy for PrEP, GS-6207, GS-9620 and/or
GS-968 may never be successfully commercialized, and Gilead may be
unsuccessful in developing an HIV cure strategy. 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 Descovy,
Truvada and Biktarvy, including BOXED WARNINGS, is available
at www.gilead.com.
Descovy, Descovy for PrEP, Truvada, Truvada for
PrEP, Biktarvy, and Gilead 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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