ViiV Healthcare and the pan-Canadian Pharmaceutical Alliance (pCPA) successfully finalize negotiations for APRETUDE for HIV-1 Pre-Exposure Prophylaxis

Canada NewsWire

MONTRÉAL, Feb. 13, 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 it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) 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

ViiV Healthcare is committed to ensuring timely public access for APRETUDE to help reduce the risk of sexually acquired HIV-1 infection and make progress towards global targets of ending HIV by 2030, which Canada endorsed.2,3 ViiV Healthcare recognizes the pCPA’s efforts and shared commitment to achieving this goal. This milestone underscores the need to expedite public reimbursement and as such, ViiV Healthcare looks forward to working with provincial and territorial governments and other stakeholders to make APRETUDE available through public drug plans.

APRETUDE is the first and only long-acting injectable approved in Canada and 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. 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, giving Canadians more options for PrEP.1 


Tharani Napper, Government Affairs & Market Access Director, ViiV Healthcare Canada:
“APRETUDE represents a new prevention tool to help combat HIV in Canada. We are excited to work with regional governments and stakeholders to secure reimbursement in every province and territory, ensuring that people who could benefit from PrEP across Canada have access to APRETUDE.”


Michael Kwag, Executive Director, Community Based Research Centre (CBRC):
 “With this announcement, people and communities at risk or affected by HIV will soon have more opportunities to choose the prevention option that is right for them. This marks a significant advancement in our mission to address HIV in Canada, especially in light of the rising number of cases in recent years. I commend the ongoing efforts of ViiV and the pCPA to strengthen HIV prevention in Canada by making APRETUDE accessible through public reimbursement.”

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 HIV

HIV (human immunodeficiency virus) is a virus that attacks the body’s immune system.4 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.5

If HIV is not treated, it can lead to AIDS (acquired immunodeficiency virus). AIDS is the most severe stage of HIV (Stage 3).6 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 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.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.ca.  

1 APRETUDE Product Monograph (2024). ViiV. Available at: www.viivhealthcare.ca
2
World Health Organization. Research & development for HIV/AIDS. Available at: https://www.who.int/observatories/global-observatory-on-health-research-and-development/analyses-and-syntheses/hiv-aids/global-strategic-direction#:~:text=The%20international%20community%20has%20committed,established%20for%202020%20and%202025. Accessed January 13, 2025.
3 Public Health Agency of Canada. Reducing the health impact of sexually transmitted and blood-borne infections in Canada by 2030: A pan-Canadian STBBI framework for action. Available at: Reducing the health impact of sexually transmitted and blood-borne infections in Canada by 2030: A pan-Canadian STBBI framework for action – Canada.ca
4 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).
5 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.
6 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).
7 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
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: HIV in Canada, Surveillance Report to December 31, 2022 – Canada.ca

SOURCE ViiV Healthcare