– First Phase 3 HIV Prevention Trial 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 –
MISSISSAUGA, ON, June 26,
2024 /CNW/ - Gilead Sciences Canada 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 per cent efficacy
for the investigational use of HIV prevention in cisgender
women.
HIV remains an epidemic in Canada, with six Canadians dying on average
every week of HIV-related illnesses and 35 more diagnosed with HIV
each week.i While currently available oral HIV
prevention options can reduce the risk of acquiring sexually
transmitted HIV by more than 90 per cent when taken as
prescribed,ii barriers remain including low awareness of
transmission behaviours and prevention, recurring medication use,
stigma and discrimination.iii
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 early data showing zero infections and 100 per cent
efficacy, twice-yearly lenacapavir has potential as a new option to
prevent HIV transmission," said Wendy
Arnott, Executive Director of Medical Affairs, Gilead
Sciences Canada. "We remain focused on our goal of ending the HIV
epidemic globally and here in Canada. We look forward to seeing further
results from the PURPOSE clinical program."
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 2,134 women
in the lenacapavir group (incidence 0.00 per 100 person-years).
There were 16 incident cases among 1,068 women in the Truvada group
(incidence 1.69 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 (39
incident cases among 2,136 women, incidence 2.02 per 100
person-years) 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.
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.
In Canada, Truvada®
is indicated in combination with safer sex practices for PrEP to
reduce the risk of sexually acquired HIV -1 infection in adults at
high risk.iv
Descovy® is indicated for pre-exposure prophylaxis
(PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk
adults and adolescents weighing ≥ 35 kg, excluding individuals at
risk from receptive vaginal sex.v
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. More information about the PURPOSE program can be
found at Clinicaltrials.gov.
Important Safety Information about
TRUVADA®
For all important safety information for TRUVADA, including
conditions of clinical use, contraindications, warnings and
precautions, adverse reactions and drug interactions, please see
the Canadian Product Monograph at www.gilead.ca.
Important Safety Information about
DESCOVY®
Safety and efficacy of DESCOVY for HIV-1 PrEP in children
weighing <35 kg have not been established.
DESCOVY does not prevent other sexually transmitted infections
or cure HIV infection or AIDS.
The DESCOVY Product Monograph includes a Serious Warnings and
Precautions Box:
Post-treatment Exacerbation of Hepatitis B Virus: 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 individuals infected with HBV. Discontinuation
of DESCOVY therapy in individuals infected with HBV may be
associated with severe acute exacerbations of hepatitis due to the
emtricitabine (FTC) or tenofovir alafenamide (TAF) components of
DESCOVY. Hepatic function should be monitored closely with both
clinical and laboratory follow-up for at least several months in
individuals infected with HBV who discontinue DESCOVY. If
appropriate, initiation of anti-hepatitis B therapy may be
warranted.
Risk of Drug Resistance with Use of DESCOVY for HIV-1 PrEP in
Undiagnosed Early HIV-1 Infection: DESCOVY used for HIV-1 PrEP must
only be prescribed to individuals confirmed to be HIV-negative
immediately prior to initiating and at least every 3 months during
use. Drug-resistant HIV-1 variants have been identified with use of
FTC/TDF for HIV-1 PrEP following undetected acute HIV-1 infection.
Do not initiate DESCOVY for HIV-1 PrEP if signs or symptoms of
acute HIV-1 infection are present unless negative infection status
is confirmed.
The safety and efficacy of DESCOVY for HIV-1 PrEP in individuals
at risk from receptive vaginal sex have not been studied.
DESCOVY should not be coadministered with products containing
any of the same components, or with products containing lamivudine
or tenofovir disoproxil fumarate. In addition, DESCOVY should not
be administered with adefovir dipivoxil.
For all important safety information for DESCOVY, including
contraindications, additional warnings and precautions, adverse
reactions and drug interactions, please see the Canadian Product
Monograph at www.gilead.ca.
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, COVID-19 and cancer. Gilead operates in more than
35 countries worldwide, with headquarters in Foster City, California. For more information,
visit https://gilead.ca
For more information about Gilead, please
visit the company's website at https://www.gilead.ca/, follow
Gilead on Twitter (@Gilead Sciences)
and LinkedIn, or email Gilead Public Affairs at
publicaffairscanada@gilead.com.
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i PHAC.
HIV in Canada, Surveillance Report to December 31, 2020.
https://www.canada.ca/en/public-health/services/publications/diseases-conditions/hiv-canada-surveillance-report-december-31-2020.html#surveillance.
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ii PHAC. HIV
factsheet: Biomedical prevention of HIV – PrEP and PEP.
https://www.canada.ca/en/public-health/services/publications/diseases-conditions/hiv-factsheet-biomedical-prevention-prep-pep.html
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iii Haddad
et al. HIV in Canada—surveillance report,
2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927910/
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iv TRUVADA® Product
Monograph, Mississauga, ON: Gilead Sciences Canada. July 5,
2018.
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v DESCOVY® Product
Monograph, Mississauga, ON: Gilead Sciences Canada. August 5,
2022.
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SOURCE Gilead Sciences, Inc.