ViiV Healthcare Announces Reimbursement for APRETUDE for HIV-1 Pre-Exposure Prophylaxis (PrEP) under the Non-Insured Health Benefits (NIHB) Program

Mar 26 2025 13:01 BST

MONTRÉAL , March 25, 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 APRETUDE (cabotegravir tablets and extended release injectable suspension) is now covered under the federal Non-Insured Health Benefits (NIHB) Program 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

The Non-Insured Health Benefits (NIHB) Program provides eligible First Nations and Inuit people with coverage for a range of health benefits that are not otherwise covered through private, provincial, or territorial health insurance plans or social programs.² In Canada approximately 10 per cent of all people living with HIV are Indigenous³, despite making up just five per cent of the country's population.⁴ Economic, social and systemic barriers, along with the lasting effects of racism and colonialism, all contribute to the disproportionate burden of HIV experienced by Indigenous people.⁵

The decision to reimburse APRETUDE through the NIHB Program will have a meaningful impact on HIV prevention efforts for eligible First Nations and Inuit people who are at-risk of HIV and could benefit from PrEP.

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.^6,7 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 commend the NIHB Program for prioritizing improved access to new HIV prevention options for Indigenous communities, a significant step towards addressing the disproportionate rates of HIV they experience. We look forward to continuing to work alongside other public drug plans to ensure equitable access to APRETUDE for all Canadians who could benefit from PrEP."

Jessy Dame, Director, Two-Spirit Health, Community Based Research Centre: "The inclusion of APRETUDE in the NIHB Program is an important step in addressing HIV transmission in Indigenous communities. Expanding access to prevention options is essential, but it must go hand in hand with continued investment in Indigenous-led initiatives and a holistic approach to care. This is especially critical for Two-Spirit people, who have a strong history in sexual health advocacy, but continue to experience systematic barriers due to racism and homophobia. We are encouraged that APRETUDE will now be available to more Indigenous communities and urge those on the ground to ensure it is truly accessible to those who could benefit from PrEP."

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.

In 2023, there were 2,434 new HIV diagnoses, a 35 per cent increase in new cases from the previous year.¹¹ In 2022, there were an estimated 65,270 people living with HIV in Canada, and 129 deaths attributed to HIV.¹²^,13

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	Indigenous Services Canada. Guide for pharmacy benefits for First Nations and Inuit: Non-Insured Health Benefits. Available at: https://www.sac-isc.gc.ca/eng/1576430557687/1576430636766. Accessed March 4, 2025.
³	Public Health Agency of Canada. Estimates of HIV incidence, prevalence and Canada's progress on meeting the 90-90-90 HIV targets, 2020. Available at: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/estimates-hiv-incidence-prevalence-canada-meeting-90-90-90-targets-2020.html.
⁴	Indigenous Services Canada. An update on the socio-economic gaps between Indigenous Peoples and the non-Indigenous population in Canada: Highlights from the 2021 Census. Available at: https://www.sac-isc.gc.ca/eng/1690909773300/1690909797208.
⁵	Ontario HIV Treatment Network. Indigenous People and HIV in Ontario – An Overview. Available at: https://www.ohtn.on.ca/wp-content/uploads/2015/10/Indigenous-Report-Overview.pdf.
⁶	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.
⁷	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.
⁸	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).
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.
¹⁰	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).
¹¹	Public Health Agency of Canada. HIV in 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
¹²	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
¹³	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