– First Phase 3 HIV Prevention Trial Ever to
Show Zero Infections –
– Independent Data Monitoring Committee
Recommended That Gilead Stop the Blinded Phase of the PURPOSE 1
Trial at Interim Analysis and Offer Open-Label Lenacapavir to All
Participants –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline
results from an interim analysis of its pivotal, Phase 3 PURPOSE 1
trial indicating that the company’s twice-yearly injectable HIV-1
capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the
investigational use of HIV prevention in cisgender women.
PURPOSE 1 met its key efficacy endpoints of superiority of
twice-yearly lenacapavir to once-daily oral Truvada® (emtricitabine
200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and
background HIV incidence (bHIV). Based on these results, the
independent Data Monitoring Committee (DMC) recommended that Gilead
stop the blinded phase of the trial and offer open-label
lenacapavir to all participants.
“With zero infections and 100% efficacy, twice-yearly
lenacapavir has demonstrated its potential as an important new tool
to help prevent HIV infections,” said Merdad Parsey, MD, PhD, Chief
Medical Officer, Gilead Sciences. “We look forward to additional
results from the ongoing PURPOSE clinical program and continuing
toward our goal of helping to end the HIV epidemic for everyone,
everywhere.”
These are the first data generated from Gilead’s landmark
PURPOSE program, which is the most comprehensive and diverse HIV
prevention trial program ever conducted. The PURPOSE program
comprises five HIV prevention trials around the world that are
focused on innovation in science, trial design, community
engagement and health equity.
Topline PURPOSE 1 data
PURPOSE 1, a Phase 3, double-blind, randomized study, is
evaluating the safety and efficacy of twice-yearly, subcutaneous
lenacapavir for pre-exposure prophylaxis (PrEP) and once-daily oral
Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg;
F/TAF) in more than 5,300 cisgender women and adolescent girls aged
16-25 across 25 sites in South Africa and three sites in Uganda.
The drugs are being tested in parallel, with one group receiving
twice-yearly lenacapavir and one group taking once-daily oral
Descovy. Additionally, a third group was assigned once-daily oral
Truvada. Study participants were randomized in a 2:2:1 ratio to
lenacapavir, Descovy and Truvada, respectively. Because effective
PrEP options already exist, there is broad consensus in the PrEP
field that a placebo group would be unethical; thus, the trial used
bHIV as the primary comparator and Truvada as a secondary
comparator.
There were 0 incident cases of HIV infection among women in the
lenacapavir group (incidence 0.00 per 100 person-years). The
results demonstrated superiority of twice-yearly lenacapavir over
bHIV (primary endpoint, incidence 2.41 per 100 person-years) and
superiority of twice-yearly lenacapavir over once-daily Truvada
(secondary endpoint), with p<0.0001 for both endpoints. In the
trial, lenacapavir was generally well-tolerated and no significant
or new safety concerns were identified.
HIV incidence in the Descovy group was numerically similar to
that in the Truvada group and was not statistically superior to
bHIV. Previous clinical trials among cisgender women have commonly
found challenges with adherence to daily oral pills for PrEP, and
adherence analyses for Descovy and Truvada from PURPOSE 1 are
ongoing. In the trial, both Descovy and Truvada were generally
well-tolerated and no new safety concerns were identified.
More detailed data from PURPOSE 1 will be presented at a future
conference.
“Twice-yearly lenacapavir for PrEP, if approved, could provide a
critical new choice for HIV prevention that fits into the lives of
many people who could benefit from PrEP around the world—especially
cisgender women,” said Linda-Gail Bekker, MBChB, DTM&H, DCH,
FCP(SA), PhD, Director of the Desmond Tutu HIV Center at the
University of Cape Town, South Africa, and past President of the
International AIDS Society. “While we know traditional HIV
prevention options are highly effective when taken as prescribed,
twice-yearly lenacapavir for PrEP could help address the stigma and
discrimination some people may face when taking or storing oral
PrEP pills, as well as potentially help increase PrEP adherence and
persistence given its twice-yearly dosing schedule.”
The use of lenacapavir and the use of Descovy for the prevention
of HIV in cisgender women are investigational and have not been
determined to be safe or efficacious and are not approved anywhere
globally.
Additional PURPOSE trials assessing twice-yearly lenacapavir
for PrEP are ongoing
Gilead expects results in late 2024/early 2025 from the
program’s other pivotal trial, PURPOSE 2, which is assessing
twice-yearly lenacapavir for PrEP among cisgender men who have sex
with men, transgender men, transgender women and gender non-binary
individuals who have sex with partners assigned male at birth in
Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the
United States. The regulatory filing for lenacapavir for PrEP will
include the results of both PURPOSE 1 and PURPOSE 2, if positive,
in order to ensure lenacapavir for PrEP can be approved for
multiple populations and communities most in need of additional HIV
prevention options.
Gilead is committed to partnering with communities that are
disproportionately affected by HIV in their respective countries
and regions, and community input on the PURPOSE trials has been
instrumental in factors ranging from program design to participant
recruitment strategies. This kind of collaborative approach will
continue to help Gilead implement clinical trials with rigor,
innovation and intentional inclusion of communities that have
historically been underrepresented in HIV prevention research. It
will also help bolster the post-implementation science activities
that Gilead will conduct for PURPOSE 1 and future successful
trials.
Gilead recognizes the importance of helping to enable access in
order for twice-yearly lenacapavir for PrEP, if approved by
regulatory authorities, to achieve the broadest impact. In light of
today’s milestone and the company’s ongoing commitment to
communities affected by HIV, Gilead intends to brief community
partners and provide a public statement regarding its planned
access approach for high-incidence, resource-limited countries,
which are primarily low- and lower-middle-income countries.
More information about the PURPOSE program, including individual
trial descriptions, populations and locations, can be found at
www.purposestudies.com.
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 by the U.S.
FDA.
U.S. Important Safety Information 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 individuals
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
individuals 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 individuals with HBV who discontinue DESCOVY. If appropriate,
anti-hepatitis B therapy may be warranted
Contraindication
- DESCOVY FOR PrEP is contraindicated in individuals with unknown
or positive HIV status
Warnings and precautions
- 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 individuals 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 individuals 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 individuals 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 individuals to strictly
adhere to daily dosing, as efficacy is strongly correlated with
adherence. Some individuals, such as adolescents, may benefit from
more frequent visits and counseling
- 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 DESCOVY in individuals with estimated creatinine clearance
(CrCl) <30 mL/min. Individuals with impaired renal function
and/or taking nephrotoxic agents (including NSAIDs) are at
increased risk of renal-related adverse reactions. Discontinue
DESCOVY in individuals who develop clinically significant decreases
in renal function or evidence of Fanconi syndrome. Monitor renal
function in all individuals (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
individuals 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 individuals. In individuals with chronic
kidney disease, assess serum phosphorus
About Gilead HIV
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, COVID-19, and cancer. Gilead operates in more than
35 countries worldwide, with headquarters in Foster City,
California.
For more than 35 years, Gilead has been a leading innovator in
the field of HIV, driving advances in treatment, prevention and
cure research. Gilead researchers have developed 12 HIV
medications, including the first single-tablet regimen to treat
HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP)
to help reduce new HIV infections, and the first long-acting
injectable HIV treatment medication administered twice-yearly. Our
advances in medical research have helped to transform HIV into a
treatable, 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, collaborations and
charitable giving, 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 was recognized as
the number one philanthropic funder of HIV-related programs in a
report released by Funders Concerned About AIDS.
Learn more about Gilead’s unique collaborations worldwide and
the work to help end the global HIV epidemic.
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 and complete
clinical trials in the anticipated timelines or at all, and the
possibility of unfavorable results from ongoing and additional
clinical trials, including those involving Descovy, Truvada and
lenacapavir (such as PURPOSE 1 and PURPOSE 2); uncertainties
relating to regulatory applications and related filing and approval
timelines, and the risk that any such approvals, if granted, may be
subject to significant limitations on use; the possibility that
Gilead may make a strategic decision to discontinue development of
Descovy and lenacapavir for indications currently under evaluation
and, as a result, Descovy and lenacapavir may never be successfully
commercialized for such indications; 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, 2024, 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 involve risks and
uncertainties, 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 Descovy
and Truvada, including Boxed Warnings, is available at
www.gilead.com
Descovy, Descovy for PrEP, Gilead, the Gilead
logo, Truvada, and Truvada for PrEP 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) and LinkedIn, or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20240620044585/en/
Jacquie Ross, Investors investor_relations@gilead.com
Ashleigh Koss, Media public_affairs@gilead.com
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