- Approved for pre-exposure prophylaxis (PrEP) to reduce the risk
of sexually acquired HIV infection in at-risk adults and
adolescents aged 12 years and older, weighing at least 35 kg,
including men who have sex with men, transgender women, and
cisgender women.
- APRETUDE (cabotegravir extended release injectable suspension)
is the first and only long-acting injectable PrEP treatment
approved in Canada.
- Given as few as six times per year after initiation and
demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF
tablets) in reducing the risk of HIV acquisition in 2 clinical
trials.1
- The latest Canadian surveillance data shows that there were
1,833 new HIV diagnoses in 2022, a 24.9 per cent increase from
2021.2
MONTRÉAL, May 13, 2024
/CNW/ - ViiV Healthcare, the global specialist HIV company
majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and
Shionogi as shareholders, announced that Health Canada has granted
approval for APRETUDE (cabotegravir tablets and extended
release injectable suspension) for pre-exposure prophylaxis (PrEP)
to reduce the risk of sexually acquired HIV-1 infection in at risk
individuals who are HIV-1 negative.1 APRETUDE is
indicated for at-risk adults and adolescents aged 12 years and
older and weighing at least 35 kg for PrEP to reduce the risk of
sexually acquired HIV-1 infection.1
APRETUDE is the only long-acting injectable HIV PrEP option
approved in Canada that reduces
the number of doses needed for effective HIV prevention from daily
pills to as few as six injections per year. Cabotegravir tablets
and extended release injectable suspension for PrEP has
demonstrated superior efficacy to daily oral
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF tablets) in
reducing the risk of HIV acquisition in 2 clinical trials, giving
Canadians more options for PrEP.1
Jean-Francois Fortin, Country
Medical Director, Canada at ViiV
Healthcare, said: "With the approval of APRETUDE in
Canada, we are proud to be able to
offer a new prevention option for Canadians at risk of acquiring
HIV. We are confident that by providing another highly effective
preventative option for Canadians, we are one step closer to our
collective goal of ending the HIV epidemic. We look forward to
working with provincial, territorial, and national health
authorities to bring APRETUDE to Canadians across the country."
HIV remains a critical public health issue in Canada, with cases of HIV increasing by 24.9
per cent in 2022 from 2021.2 PrEP has been
identified as an effective tool in reducing new cases of HIV, key
to ending the HIV epidemic. Despite the wide availability of daily
oral PrEP, inconsistent adherence as well as structural and
cultural barriers lead to underutilization in key populations.
Health Canada approval was
based on the results of two key phase IIb/III studies, HPTN 083 and
HPTN 084, which evaluated the safety and efficacy of cabotegravir
long-acting for PrEP in men who have sex with men, transgender
women, and cisgender women who were at increased risk of
HIV.3,4 The studies demonstrated that cabotegravir
long-acting injectables for PrEP was superior to daily oral
emtricitabine/tenofovir disproxil fumarate (FTC/TDF), with clinical
trial participants experiencing 69 per cent lower rate of HIV
acquisition compared to FTC/TDF tablets in HPTN 083, and a 90 per
cent lower rate of HIV acquisition compared to FTC/TDF tablets in
HPTN 084.5,6
About Cabotegravir extended
release injectable suspension
Cabotegravir extended release injectable suspension is the first
and only long-acting injectable pre-exposure prophylaxis (PrEP)
option proven superior to daily oral FTC/TDF in reducing HIV
acquisition. It is indicated for at-risk adults and adolescents
aged 12 years and older, weighing at least 35 kg for PrEP to reduce
the risk of sexually acquired HIV-1 infection. Cabotegravir
extended release injectable suspension is administered as a single
600 mg (3-ml) intramuscular (IM) injection of cabotegravir in the
buttocks by a health care professional every two months after two
initiation injections administered one month apart. Cabotegravir
tablets can be used as an optional oral lead-in to assess
tolerability or as short-term oral PrEP in individuals who will
miss planned dosing with cabotegravir extended release injectable
suspension. Cabotegravir is an integrase strand transfer inhibitor
(INSTI). INSTIs, like cabotegravir extended release injectable
suspension, inhibit HIV replication by preventing the viral DNA
from integrating into the genetic material of human immune cells
(T-cells). This step is essential in the HIV replication cycle and
is also responsible for establishing chronic
disease.1
About HPTN 083
(NCT02720094)7
The HPTN 083 trial is a phase IIb/III double blind
non-inferiority trial designed to evaluate the safety and efficacy
of long-acting injectable cabotegravir for HIV prevention
administered every eight weeks compared to daily oral FTC/TDF
tablets (200 mg/300 mg). The trial included the prespecified
ability to test for superiority of long-acting cabotegravir over
FTC/TDF. The trial design included an oral lead-in phase to assess
tolerability to cabotegravir before administering the intramuscular
injection. HPTN 083 was conducted in 4,566 men who have sex with
men and transgender women who have sex with men. The study opened
to enrollment in November 2016 at
research centres in Argentina,
Brazil, Peru, United
States, South Africa, and
Vietnam.5
At a pre-planned interim review of trial data, a multinational
Data and Safety Monitoring Board (MDSMB) recommended that the
blinded phase of HPTN 083 be stopped due to the demonstration of
superior efficacy of cabotegravir when compared to daily, oral
FTC/TDF and that subjects randomized to the active FTC/TDF group be
offered cabotegravir. The most common adverse reactions (all
grades) observed in at least 1 per cent of subjects receiving long
acting cabotegravir were injection sites reactions, diarrhea,
headache, pyrexia, fatigue, sleep disorders, nausea, dizziness,
flatulence, and abdominal pain.5
For further information on HPTN 083 please see
https://clinicaltrials.gov/ct2/show/NCT02720094.
About HPTN 084
(NCT03164564)6
The HPTN 084 trial is a phase III double blind superiority trial
designed to evaluate the safety and efficacy of the long-acting
injectable cabotegravir for HIV prevention administered every eight
weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg) in
3,224 cisgender women who are at increased risk of HIV acquisition.
The trial design included an oral lead-in phase to assess
tolerability to cabotegravir before administering the intramuscular
injection. HPTN 084 opened to enrolment in November 2017 and is being conducted at research
centres in Botswana, Kenya, Malawi, South
Africa, Eswatini, Uganda,
and Zimbabwe.6
The MDSMB recommended early termination of the blinded,
randomized portion of HPTN 084 after an interim analysis indicated
that pre-specified stopping criteria had been met (superiority of
cabotegravir compared with FTC/TDF). The most common adverse
reactions (all grades) observed in at least 1% of subjects
receiving long acting cabotegravir were injection site reactions,
diarrhea, headache, fatigue, sleep disorders, nausea, dizziness,
abdominal pain, vomiting, myalgia, and rash.6 For
further information please see
https://clinicaltrials.gov/ct2/show/NCT03164564.
About HIV
HIV (human immunodeficiency virus) is a virus that attacks the
body's immune system.8 HIV is spread by contact with
certain bodily fluids of a person with HIV, most commonly during
unprotected sex (sex without a condom or HIV medicine to prevent or
treat HIV), or through sharing injected drug
equipment.9
If HIV is not treated, it can lead to AIDS (acquired
immunodeficiency virus). AIDS is the most severe stage of HIV
(Stage 3).10 There is currently no cure for HIV, but
with proper treatment and care, people with HIV can maintain a high
quality of life and avoid passing HIV to others.
At the end of 2022, 39 million people lived with HIV around the
world, with 1.3 million new diagnoses that year and 630,000 deaths
from AIDS-related illnesses.11
Important Safety Information for
APRETUDE for PrEP1
The APRETUDE Product Monograph includes a Serious Warning and
Precautions Box:
RISK OF DRUG RESISTANCE WITH USE OF APRETUDE IN UNDIAGNOSED
HIV-1 INFECTION.1
Individuals must be tested for HIV-1 infection prior to
initiating APRETUDE and should be tested for HIV-1 infection with
each subsequent injection of APRETUDE. APRETUDE must not be
prescribed until confirmation of negative HIV-1 infection status.
Drug-resistant HIV-1 variants have been identified with use of
APRETUDE by individuals with undiagnosed HIV-1 infection. Do not
initiate APRETUDE if signs or symptoms of acute HIV-1 infection are
present unless negative infection status is
confirmed.1 Individuals who become infected with
HIV-1 while receiving APRETUDE must transition to a complete HIV-1
treatment regimen.
The Product Monograph also includes warnings and precautions
regarding hypersensitivity reactions, hepatotoxicity (liver damage)
and depressive disorders.1
The Product Monograph, posted at
www.viivhealthcare.ca, should be consulted for complete
administration and safety information, including contraindications,
additional warnings and precautions, adverse reactions and drug
interactions.1 Prior to being posted online, the Product
Monograph is also available by calling 1-877-393-8448.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established
in November 2009 by GSK (LSE: GSK)
and Pfizer (NYSE: PFE) dedicated to delivering advances in
treatment and care for people living with HIV and for people who
are at risk of acquiring HIV. Shionogi became a ViiV shareholder in
October 2012. The company's aims are
to take a deeper and broader interest in HIV and AIDS than any
company has done before and take a new approach to deliver
effective and innovative medicines for HIV treatment and
prevention, as well as support communities affected by HIV.
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1 APRETUDE Product
Monograph (2024), ViiV. Available at:
www.viivhealthcare.ca
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2 PHAC. HIV in Canada:
2022 surveillance highlights. Available at: HIV in Canada: 2022
Surveillance highlights - Canada.ca. Accessed January 19,
2024.
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3 Marzinke M,
Grinsztejn B, Fogel J, Piwowar-Manning EM et al, Laboratory
Analysis of HIV Infections in HPTN 083: Injectable CAB for PrEP.
Conference on Retroviruses and Opportunistic Infections Abstract
153
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4 Delany-Moretlwe S,
Hughes JP et al. Long acting injectable cabotegravir is safe and
effective in preventing HIV infection in cisgender women. HIV
Research for Prevention Virtual Conference (HIVR4P 2021) abstract
HY01.02, 2021.
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5 Clinical Trials.gov -
Safety and Efficacy Study of Injectable Cabotegravir Compared to
Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC),
For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and
Transgender Women Who Have Sex with Men. Available at
https://clinicaltrials.gov/ct2/show/NCT02720094. Last accessed
October 2022.
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6 Clinical Trials.gov -
Evaluating the Safety and Efficacy of Long-Acting Injectable
Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure
Prophylaxis in HIV-Uninfected Women. Available at
https://clinicaltrials.gov/ct2/show/NCT03164564. Last accessed
October 2022.
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7 DC statement on FDA
approval of drug for HIV prevention. News release CDC NCHHSTP
Newsroom. July 16, 2012. Accessed September 7, 2021.
https://www.cdc.gov/nchhstp/newsroom/2012/fda-approvesdrugstatement.html
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8 CDC. About HIV.
Available at:
https://www.cdc.gov/hiv/basics/whatishiv.html.
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9 HIV.gov. What Are HIV
and AIDS? Available at:
https://www.hiv.gov/hiv-basics/overview/about-hiv-and-aids/what-are-hiv-and-aids/.
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10 CDC. About HIV.
Available at:
https://www.cdc.gov/hiv/basics/whatishiv.html#:~:text=People%20who%20take%20HIV%20treatment,into%20Stage%203%20(AIDS)..
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11 UNAIDS. Global HIV
& AIDS Statistics – Fact sheet. Available at:
https://www.unaids.org/en/resources/fact-sheet
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SOURCE ViiV Healthcare