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

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 Indigenous 3 , 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.

__________________

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

News Provided by PR Newswire via QuoteMedia

PFE
The Conversation (0)
Arvinas and Pfizer Announce Upcoming Vepdegestrant  Poster Presentations at the 2023 European Society for Medical Oncology  Breast Cancer Annual Congress

Arvinas and Pfizer Announce Upcoming Vepdegestrant Poster Presentations at the 2023 European Society for Medical Oncology Breast Cancer Annual Congress

Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced they will present updated data related to vepdegestrant (ARV-471) at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress. Vepdegestrant is a novel investigational PROTAC ® estrogen receptor (ER) protein degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with early and locally advanced or metastatic ER positivehuman epidermal growth factor receptor 2 (HER2) negative (ER+HER2-) breast cancer. Four posters will be presented during the poster session at the annual congress, which will be held from May 11-13, 2023, in Berlin, Germany.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Pfizer Reports First-Quarter 2023 Results

Pfizer Reports First-Quarter 2023 Results

  • First-Quarter 2023 Revenues of $18.3 Billion
    • Expected Decline in Comirnaty (1) Revenue Drove 26% Operational Decrease in First-Quarter 2023 Revenues
    • First-Quarter 2023 Revenues from Comirnaty (1) and Paxlovid of $7.1 Billion
    • Excluding Contributions from Comirnaty (1) and Paxlovid, Revenues Grew 5% Operationally
  • First-Quarter 2023 Reported Diluted EPS (2) of $0.97, a Year-Over-Year Decline of 29%, and Adjusted Diluted EPS (3) of $1.23, a Year-Over-Year Decline of 24%
  • Pfizer Reaffirms Full-Year 2023 Financial Guidance (4)
  • Pfizer Continued to Make Significant Progress Toward an Unprecedented Number of Anticipated New Product and Indication Launches; Milestones Include FDA Approvals for Zavzpret, Cibinqo for Adolescents and Prevnar 20 in Pediatric Patients

Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2023 and reaffirmed full-year 2023 financial guidance.

The first-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer's R&D pipeline can be found at www.pfizer.com .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
XTANDI®  plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

XTANDI® plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

Data from Phase 3 EMBARK trial to be presented as a plenary session during the 2023 American Urological Association Annual Meeting

Results show the potential for XTANDI to add to the standard of care in prostate cancer, if approved

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
U.S. FDA Approves PREVNAR 20®, Pfizer's 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

U.S. FDA Approves PREVNAR 20®, Pfizer's 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

  • PREVNAR 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect against all 20 serotypes contained in the vaccine
  • PREVNAR 20 builds on PREVNAR 13 ® and includes seven additional serotypes shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases. 1
  • The vaccine further advances Pfizer's pediatric pneumococcal vaccine portfolio and builds on more than 20 years of Pfizer leadership, legacy and innovation in developing pneumococcal conjugate vaccines

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20 ® (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR ® .

"Today's FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children," 1,2 said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. "This important PREVNAR 20 approval builds on more than 20 years of real-world impact with PREVNAR and PREVNAR 13, safety data, and effectiveness; highlighting Pfizer's leadership in developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life threatening infections. We are grateful to the families and clinical investigators who participated in this research and our colleagues who have worked tirelessly to develop this breakthrough vaccine."

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Pfizer Declares Second-Quarter 2023 Dividend

Pfizer Declares Second-Quarter 2023 Dividend

Board of Directors approves quarterly cash dividend of $0.41 per share

Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.41 second-quarter 2023 dividend on the company's common stock, payable June 9, 2023, to holders of the Common Stock of record at the close of business on May 12, 2023. The second-quarter 2023 cash dividend will be the 338th consecutive quarterly dividend paid by Pfizer.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Dexcom Appoints Jon Coleman as Chief Commercial Officer

DexCom, Inc. (NASDAQ: DXCM), the global leader in glucose biosensing, today announced the appointment of Jon Coleman as chief commercial officer. In this role, Mr. Coleman will assume responsibility for Dexcom's global commercial organization, including global sales, marketing and customer experience.

Mr. Coleman joins Dexcom with more than 30 years of global commercial leadership experience across multiple healthcare segments and channels. Mr. Coleman served as an executive officer of Masimo Corporation (NASDAQ: MASI), where he held roles of increasing responsibility across his fifteen-year tenure. This included serving as president of Masimo's commercial teams where he oversaw the consolidation of its worldwide hospital sales, OEM, alternate care sales, and clinical teams along with the customer service and hospital conversion teams. Mr. Coleman also held significant roles at Pfizer's (NYSE: PFE) Consumer Healthcare business, leading as vice president and general manager of Canada and the Caribbean region after several years of regional leadership in Asia and Latin America. Across his various roles at these organizations, Mr. Coleman established a track record of scaling operations, developing innovative products, entering new markets, and delivering strong growth performance.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Pfizer Invites Public to View and Listen to Webcast of April 29 Conference Call with Analysts

Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10:00 a.m. EDT on Tuesday, April 29, 2025. The purpose of the call is to provide an update on Pfizer's results, as reflected in the company's First Quarter 2025 Performance Report, to be issued that morning.

To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com/investors . Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance of the conference call.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Cardiol Therapeutics (TSX:CRDL)

Cardiol Therapeutics


Keep reading...Show less

BMO Expands Canadian Depositary Receipt Lineup with 10 New Listings from Europe and Japan

BMO's CDRs offer enhanced portfolio diversification opportunities for Canadian investors enabling them to hold shares in international companies that trade on a Canadian exchange in Canadian dollars

Bank of Montreal (BMO) announced 10 new CDRs will begin trading on the Cboe Canada exchange today. The initial offering of these new CDRs has closed.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Two people wearing lab coats shake hands in business agreement.

What is In-Licensing?

When it comes to investing in pharmaceutical companies, looking at pipelines and research and development prospects is important. But in-licensing is also key when examining these stocks.

In fact, in-licensing deals might be the pharmaceutical industry’s preferred mode of business development these days — perhaps even more so than M&A activity. These agreements can prove to be very fruitful for companies and their share prices.

The in-licensing strategy is likewise attractive to investors, as in-licensing drugs expedites corporate development while also mitigating risk. So let’s clear up some common questions around the strategy. The article below runs through what it means to in-license a drug and how in-licensing differs from an acquisition. It also covers how royalties affect returns. It’s key for investors to be aware of these intricacies so that they can interpret a firm’s actions correctly and elect to buy or sell at the right time.

Keep reading...Show less
Test tubes.

Amgen, Merck and Pfizer Release Latest Quarterly Earnings, Share 2025 Plans

Earnings season is in full swing in the pharma sector with major players sharing their latest results.

On Tuesday (February 4), Amgen (NASDAQ:AMGN), Merck (NYSE:MRK) and Pfizer (NYSE:PFE) released financial results for the most recent quarter, providing critical data points for evaluating investment potential.

Keep reading...Show less

Latest Press Releases

Related News

×