Gilead Sciences, Inc. (Nasdaq: GILD) today announced the
company’s upcoming contributions to the 11th International AIDS
Society (IAS) Conference on HIV Science, taking place virtually
from July 18-21. Thirty-one abstracts reflect Gilead’s ongoing
commitment to scientific innovation, a key pillar to addressing
unmet needs in HIV treatment and prevention. Beyond presenting new
scientific data from the company’s HIV research and development
programs, Gilead will convene a symposium featuring a diverse,
global panel of leading HIV researchers and people living with HIV,
to discuss potential clinical pathways to achieve a functional cure
and community perspectives on the process.
“Continued scientific innovation is essential to helping end the
global HIV epidemic and we are committed to advancing the next
generation of therapies to improve the care of people and
communities impacted by this disease,” said Merdad Parsey, MD, PhD,
Chief Medical Officer, Gilead Sciences. “Our data at this year’s
meeting demonstrate the important scientific advancements we are
making to help address critical unmet needs for people with HIV and
those who could benefit from PrEP medicines.”
Presentations from Gilead’s HIV research program will
include:
- A pooled analysis of 192-week data from open-label extension
periods of two Phase 3 trials evaluating the once-daily, single
tablet regimen, Biktarvy® (bictegravir 50 mg/emtricitabine 200
mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve
adults living with HIV
- 72-week data from the BRAAVE trial evaluating the safety and
efficacy of switching to Biktarvy in Black or African American
adults who are virologically supressed
- Data from the Phase 2/3 CAPELLA trial evaluating the company’s
investigational, long-acting subcutaneously administered HIV-1
capsid inhibitor, lenacapavir, in heavily treatment-experienced
people living with multidrug resistant HIV
- Interim Phase 2 data from the open-label CALIBRATE trial
evaluating the safety and efficacy of lenacapavir as an
investigational, long-acting HIV capsid inhibitor in combination
with other antiretroviral agents in treatment-naïve people living
with HIV
- Data from a Phase 1b trial examining the impact from the
investigational TLR7 agonist, vesatolimod, between certain immune
responses in people living with HIV on antiretroviral therapy
- Prevention research, including data exploring adherence to PrEP
medicines among new PrEP users initiating Descovy (emtricitabine
200 mg/tenofovir alafenamide 25 mg) for PrEP®, real-world
utilization of PrEP medicines during the COVID-19 pandemic and the
safety and efficacy profile of Descovy for PrEP, as well as the use
of novel study designs for HIV prevention trials
Select accepted abstracts are as follows:
HIV Treatment Research
Week 72 Outcomes and COVID-19 Impact From
the BRAAVE 2020 Study: A Randomized Switch to B/F/TAF in African
American Adults Living With HIV
Long-Term Efficacy Among Participants
Switched to Bictegravir/Emtricitabine/Tenofovir Alafenamide
(B/F/TAF) from Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) With
Pre-Existing Resistance and Viral Blips
Long-Term Analysis of B/F/TAF in
Treatment-Naïve Adults Living With HIV Through Four Years of
Follow-Up
Achievement of Undetectable HIV-1 RNA in
the B/F/TAF Treatment-Naïve Clinical Trials
Switching to
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults
Aged 65 Years or Older: Week 96 Results From an International,
Phase 3b, Open-Label Trial
Investigational Long-Acting HIV
Treatment Research (Lenacapavir)
Long-Acting Subcutaneous Lenacapavir Dosed
Every 6 Months as Part of a Combination Regimen in Treatment-Naïve
People With HIV: Interim 16-Week Results of a Randomized,
Open-Label, Phase 2 Induction-Maintenance Study (CALIBRATE)
Efficacy and Safety of Long-Acting
Subcutaneous Lenacapavir in Phase 2/3 in Heavily
Treatment-Experienced People With HIV: Week 26 Results
(CAPELLA)
HIV Cure Research
Proteomic Evidence of Vesatolimod-Induced
Enhancement of “Cross-talk” Between Innate and Adaptive Immune
Cells in HIV Controllers on ART
HIV Prevention Research
Outcomes of Participants Switching from
F/TDF to F/TAF for PrEP: Week 48 Results From the DISCOVER Open
Label Phase
Comparing Adherence to HIV Pre-Exposure
Prophylaxis (PrEP) Among New, Male PrEP Users Initiating F/TAF vs.
F/TDF
Real-World Utilization of F/TDF and F/TAF
for HIV Pre-Exposure Prophylaxis During the COVID-19 Pandemic in
the U.S., December 2019 – June 2020
HIV Recent Infection Test-Based Incidence
as a Counter-Factual for New PrEP Trials
For more information, including a complete list of abstracts,
please visit: https://www.ias2021.org/the-programme.
Please see below for U.S. Indications and Important Safety
Information, including Boxed Warnings, for Biktarvy® and Descovy
for PrEP®.
Lenacapavir and vesatolimod are investigational compounds and
are not approved by the U.S. Food & Drug Administration or any
regulatory authority for any use. Their safety and efficacy have
not been established. In May 2019, FDA granted Breakthrough Therapy
Designation for the development of lenacapavir for the treatment of
HIV-1 infection in heavily treatment-experienced patients with
multi-drug resistance.
The use of Biktarvy in individuals with a history of treatment
failure or known resistance to the components of Biktarvy is
investigational, and the safety and efficacy of Biktarvy for this
use have not been established.
There is currently no cure for HIV or AIDS.
U.S. Indication for
Biktarvy
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.
U.S. Important 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.
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: Postmarketing
cases of renal impairment, including acute renal failure, proximal
renal tubulopathy (PRT), and Fanconi syndrome have been reported
with tenofovir alafenamide (TAF)–containing products. Do not
initiate Biktarvy in patients with estimated creatinine clearance
(CrCl) <30 mL/min except in virologically suppressed adults
<15 mL/min who are receiving chronic hemodialysis. 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, 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 144 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.
Dosage and administration
- Dosage: Patients weighing ≥25 kg: 1 tablet taken once
daily with or without food.
- Renal impairment: Not recommended in patients with CrCl
15 to <30 mL/min, or <15 mL/min who are not receiving chronic
hemodialysis, or <15 mL/min who are receiving chronic
hemodialysis and have no antiretroviral treatment history.
- 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.
Pregnancy and lactation
- Pregnancy: There is insufficient human data on the use
of Biktarvy during pregnancy. Dolutegravir, another integrase
inhibitor, has been associated with neural tube defects. Discuss
the benefit-risk of using Biktarvy during pregnancy and conception.
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.
U.S. Indication for Descovy for
PrEP
Descovy for PrEP is indicated in at-risk adults and adolescents
(≥35 kg) to reduce the risk of sexually acquired HIV-1 infection,
excluding individuals at risk from receptive vaginal sex.
HIV-1–negative status must be confirmed immediately prior to
initiation.
Limitation of Use:
- Descovy for PrEP is not indicated in individuals at risk of
HIV-1 from receptive vaginal sex because effectiveness in this
population has not been evaluated.
U.S. Important Safety Information and
Indication for Descovy for PrEP
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY
FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT
ACUTE EXACERBATION OF HEPATITIS B
- Descovy for PrEP must be prescribed only to patients confirmed
to be HIV negative immediately prior to initiation and at least
every 3 months during use. Drug-resistant HIV-1 variants have been
identified with use of emtricitabine/tenofovir disoproxil
fumarate
- (FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1
infection. Do not initiate if signs or symptoms of acute HIV-1
infection are present unless HIV-negative status is confirmed.
- Severe acute exacerbations of hepatitis B have been reported in
patients infected with hepatitis B virus (HBV) who discontinued
products containing FTC and/or TDF and may occur with
discontinuation of Descovy. Closely monitor hepatic function with
both clinical and laboratory follow-up for at least several months
in patients with HBV who discontinue Descovy. If appropriate,
anti-hepatitis B therapy may be warranted.
Contraindication:
- Descovy for PrEP is contraindicated in patients with unknown or
positive HIV status.
Comprehensive management to reduce risks:
- Use Descovy for PrEP to reduce the risk of HIV-1 infection as
part of a comprehensive strategy that includes adherence to daily
dosing and safer sex practices, including condoms, to reduce the
risk of sexually transmitted infections (STIs).
- HIV-1 risk factors: Behavioral, biological, or
epidemiologic HIV-1 risk factors may include, but are not limited
to: condomless sex, past or current STIs, self-identified HIV risk,
having sexual partners of unknown HIV-1 viremic status, or sexual
activity in a high-prevalence area or network.
- Reduce STI risk: Counsel on the use of STI prevention
measures (e.g., consistent and correct condom use, knowledge of
partner's HIV-1 viremic status, regular testing for STIs).
- Reduce potential for drug resistance: Only prescribe
Descovy for PrEP to patients confirmed to be HIV negative
immediately prior to initiation, at least every 3 months while
taking Descovy, and upon an STI diagnosis. HIV-1 resistance
substitutions may emerge in patients with undetected HIV-1
infection who are taking only Descovy because Descovy alone is not
a complete regimen for treating HIV-1.
- Some HIV tests may not detect acute HIV infection. Prior to
initiating Descovy for PrEP, ask patients about potential recent
exposure events. If recent (<1 month) exposures are reported or
suspected, or symptoms of acute HIV infection (e.g., fever,
fatigue, myalgia, skin rash) are present, confirm HIV-negative
status with a test approved by the FDA for use in the diagnosis of
acute HIV infection.
- If HIV-1 infection is suspected or if symptoms of acute
infection are present while taking Descovy for PrEP, convert the
Descovy for PrEP regimen to a complete HIV treatment regimen until
HIV-negative status is confirmed by a test approved by the FDA for
use in the diagnosis of acute HIV infection.
- Counsel on adherence: Counsel patients to strictly
adhere to daily dosing, as efficacy is strongly correlated with
adherence. Some patients, such as adolescents, may benefit from
more frequent visits and counseling.
Warnings and precautions:
- New onset or worsening renal impairment: Cases of acute
renal failure and Fanconi syndrome have been reported with the use
of tenofovir prodrugs. 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.
Monitor renal function in all patients (see Dosage and
Administration section).
- Lactic acidosis and severe hepatomegaly with steatosis:
Fatal cases have been reported with the use of nucleoside analogs,
including FTC and TDF. Discontinue use 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 (≥2%) in the Descovy for PrEP
clinical trial were diarrhea, nausea, headache, fatigue, and
abdominal pain.
Drug interactions:
- Prescribing information: Consult the full Prescribing
Information for Descovy for more information, warnings, and
potentially significant drug interactions, including clinical
comments.
- Metabolism: Drugs that inhibit P-gp can increase the
concentrations of tenofovir alafenamide (TAF), a component of
Descovy. Drugs that induce P-gp can decrease the concentrations of
TAF, which may lead to loss of efficacy.
- Drugs affecting renal function: Coadministration of
Descovy 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: One tablet taken once daily with or without
food.
- HIV screening: Test for HIV-1 infection immediately
prior to initiating, at least every 3 months during use, and upon
diagnosis of an STI (see Warnings and Precautions section).
- HBV screening: Test for HBV infection prior to or when
initiating Descovy.
- Renal impairment and monitoring: Not recommended in
patients with creatinine clearance (CrCl) <30 mL/min. Prior to
or when initiating Descovy, and during use on a clinically
appropriate schedule, assess serum creatinine, CrCl, urine glucose,
and urine protein in all patients. In patients with chronic kidney
disease, assess serum phosphorus.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis and cancer.
For more than 30 years, Gilead has been a leading innovator in
the field of HIV, driving advances in treatment, prevention and
cure research. Gilead researchers have developed eleven HIV
medications, including the first single tablet regimen to treat HIV
and the first once-daily oral antiretroviral tablet for
pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV
infection. These advances in medical research have helped to
transform HIV into a preventable, chronic condition for millions of
people.
Gilead is committed to continued scientific innovation to
provide solutions for the evolving needs of people affected by HIV
around the world. Through partnerships and collaborations, the
company also aims to improve education, expand access and address
barriers to care, with the goal of ending the HIV epidemic for
everyone, everywhere.
Gilead operates in more than 35 countries worldwide, with
headquarters in Foster City, California.
Forward-Looking
Statements
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 Gilead’s ability to initiate, progress or complete
clinical trials or studies within currently anticipated timelines
or at all, including those involving Biktarvy, Descovy for PrEP,
lenacapavir and vesatolimod; the possibility of unfavorable results
from such ongoing and additional clinical trials; the possibility
that Gilead may make a strategic decision to discontinue
development of lenacapavir and vesatolimod and as a result, these
compounds may never be successfully commercialized; Gilead’s
ability to receive regulatory approvals in a timely manner or at
all, including marketing approvals of lenacapavir and vesatolimod,
and the risk that any such approvals, if granted, may have
significant limitations on its use; and any assumptions underlying
any of the foregoing. These and other risks, uncertainties and
factors are described in detail in Gilead’s Quarterly Report on
Form 10-Q for the quarter ended March 31, 2021, as filed with the
U.S. Securities and Exchange Commission. These risks, uncertainties
and other factors could cause actual results to differ materially
from those referred to in the forward-looking statements. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements. The reader is
cautioned that any such forward-looking statements are not
guarantees of future performance and is cautioned not to place
undue reliance on these forward-looking statements. All
forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation and disclaims
any intent to update any such forward-looking statements.
U.S. full Prescribing Information for Biktarvy
and Descovy for PrEP, including BOXED WARNINGS, are
available at www.gilead.com.
Biktarvy, Descovy for PrEP, Gilead and the
Gilead logo are registered trademarks of Gilead Sciences, Inc., or
its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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