Quebec becomes first province to publicly reimburse APRETUDE for HIV-1 Pre-Exposure Prophylaxis (PrEP)

MONTRÉAL, March 5, 2025 /CNW/ - ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders, is pleased to announce that Quebec has become the first province to publicly reimburse 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

ViiV Healthcare commends the Quebec government for its decision to grant timely access to APRETUDE for at-risk individuals who could benefit from PrEP. APRETUDE is now listed under the Régie de L'assurance Maladie du Québec (RAMQ). With cases of HIV continuing to rise across Canada, including in Quebec where cases have increased 37 per cent between 2019 and 2022,² this decision will have a meaningful impact on HIV prevention efforts in the province.

APRETUDE is the first and only long-acting injectable approved in Canada to help reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents aged 12 years and older, and weighing at least 35kg.¹ Findings from two real-world evidence studies (OPERA and Trio Health cohorts) showed more than 99 per cent effectiveness of APRETUDE for PrEP in nearly 1,300 individuals.^3,4 APRETUDE for PrEP has demonstrated superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF tablets) in reducing the risk of HIV acquisition in two clinical trials, providing more options for PrEP for Canadians.¹

Tharani Napper, Government Affairs & Market Access Director, ViiV Healthcare Canada: "We applaud the Quebec government for prioritizing access to new HIV prevention tools like APRETUDE, an important step in our collective effort to strengthen HIV prevention in Canada. We look forward to continuing to collaborate with other provinces and territories to ensure equitable access to APRETUDE for all Canadians who could benefit from PrEP."

Alexandre Dumont Blais, Executive Director, RÉZO: "While the communities we reach continue to be over-represented in new HIV cases, Quebec's decision to include a new option for PrEP on the list of drugs reimbursed by the public plan is a step forward in HIV prevention in our province. At RÉZO, we've been informing our communities about PrEP, how it works and its effectiveness in preventing HIV for nearly 15 years. Access to PrEP remains an issue in Quebec and Canada. We believe that the more options available for PrEP, and the more financially accessible it is, the more we can increase its use and reduce new cases of HIV."

About HIV

HIV (human immunodeficiency virus) is a virus that attacks the body's immune system.⁵ 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.⁶

If HIV is not treated, it can lead to AIDS (acquired immunodeficiency syndrome). AIDS is the most severe stage of HIV infection (Stage 3).² 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.

In 2023, there were 2,434 new HIV diagnoses, a 35 per cent increase in new cases from the previous year.⁷ In 2022, there were an estimated 65,270 people living with HIV in Canada, and 129 deaths attributed to HIV.^8,9

About APRETUDE

APRETUDE (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. 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

Please consult the Product Monograph for complete safety information. 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.

² Institut national de santé publique du Québec. Publication of the Portrait of STBBIs in Quebec: 2022 and 2023 projections and the annual report of the HIV Surveillance Program in Quebec 2022. Available at: Publication of the Portrait of STBBIs in Quebec: 2022 and 2023 Projections and the 2022 Annual Report of the HIV Surveillance Program in Quebec

³ Mills, A.M et al. ID Week 2024 Oral presentation 508. Cabotegravir Long-Acting for Pre-Exposure Prophylaxis (PrEP): Real World Data on On-Time Dosing, HIV Testing and HIV Acquisition from the OPERA Cohort. Available at: https://viivhcmedinfo.com/medical-congress/idweek-2024.

⁴ Ramgopal, M et al ID Week 2024 Oral presentation 505. Real-World Use of Cabotegravir Long-Acting for Pre-Exposure Prophylaxis: Data from Trio Health Cohort. Available at: https://viivhcmedinfo.com/medical-congress/idweek-2024.

⁵ CDC. About HIV. Available at: https://www.cdc.gov/hiv/about/#:~:text=people%20who%20take%20HIV%20treatment%20as%20prescribed%20may%20never%20move%20into%20Stage%203%20(AIDS)

⁶ 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

⁷ Public Health Agency of Canada. HIV in Canada: 2023 surveillance highlights. Available at: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/hiv-2023-surveillance-highlights-infographic.html.

⁸ Public Health Agency of Canada. Canada's progress towards ending the HIV epidemic. Available at: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/canada-progress-towards-ending-hiv-epidemic.html

⁹ Public Health Agency of Canada. HIV in Canada, Surveillance Report to December 31, 2022. Available at: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/hiv-canada-surveillance-report-december-31-2022.html.

SOURCE ViiV Healthcare

Media Contact: Jaclyn Cossarini, Edelman Canada, [email protected]