ViiV HEALTHCARE ANNOUNCES POSITIVE DATA DEMONSTRATING GREATER ACCEPTABILITY OF CABOTEGRAVIR COMPARED TO LENACAPAVIR INJECTIONS FOLLOWING A SINGLE DOSE 

  • Initial data from the CLARITY study are first to compare acceptability and tolerability of single-dose cabotegravir (CAB) and lenacapavir (LEN) long-acting injections, in 63 HIV-negative adults
  • Sixty-nine percent of individuals found CAB injections to be ‘totally or very acceptable’ versus 48% for LEN injections, and 90% of participants and 86% of healthcare providers preferred CAB injections over LEN
  • Findings could help inform expectations and decision-making when initiating long-acting HIV injectables

Montreal, Quebec, April, 23, 2026 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi* as shareholders, announced findings from the phase 1 CLARITY open-label, crossover study, the first head-to-head comparison of injection site reaction acceptability and tolerability of long-acting injectable HIV prevention medications, cabotegravir (CAB) and lenacapavir (LEN), in 63 HIV-negative adults.

Findings demonstrate cabotegravir long-acting (CAB LA) injections were more acceptable among participants compared to LEN, with 69% of participants rating CAB LA as “totally or very acceptable,” compared to 48% for LEN. 90% of HIV-negative adults and 86% of healthcare providers have indicated preference towards CAB LA as LEN injections saw more frequent injection site reactions.

These findings highlight the importance of patient-centred design in HIV prevention. Treatment experience, along with clinical efficiency, plays a critical role in whether individuals initiate and remain on prevention options.

Jean-Francois Fortin, Country Medical Director, Canada at ViiV Healthcare, said: “The outcomes of this study offer valuable insight into long-acting injectable options within Canada, and the critical role that patient experience and healthcare provider expertise have in helping Canadians make informed decisions. ViiV Canada continues to work toward our collective of goal of ending HIV, and improved uptake and adherence to preventative treatments are critical to realizing this goal.”

In the open-label crossover study, 63 HIV-negative participants were randomised to receive one medicine at Day 1, followed by the other at Day 15 - either CAB LA (a single intramuscular injection) or LEN (two subcutaneous injections). The primary endpoint was local reaction acceptability assessed seven days after each injection, and results showed clinically relevant differences in ISR acceptability. After a single dose of CAB LA and LEN, 69% (n=42/61) of individuals found CAB injections to be “totally or very acceptable” vs 48% (n=29/60) for LEN injections, which was statistically significant in a post hoc analysis (p=0.019).

Key preference data from the study:

  • Ninety percent (n=54/60) of healthy HIV-negative adults and 86% (n=6/7) of HCPs preferred CAB LA and 10% (n=6/60) and 14% (n=1/7) preferred LEN, respectively.
  • The four most common reasons cited by participants for why they preferred CAB LA (n=54) were less pain during injection administration (n=40/54), less pain or soreness after injection administration (n=33/54), how long the injection nodules or swelling last (n=31/54), and the size of the injection nodules or swelling (n=30/54).
  • The four most common reasons cited by participants for why they preferred LEN (n=6) were less pain or soreness after injection administration (n=5/6), how long the injection nodules or swelling last (n=3/6), the size of the injection nodules or swelling (n=3/6), and fewer number of side effects (n=3/6).
  • The three most common rationales for HCP preference for CAB LA (n=6) included fewer number of reported side effects (5/6), less severe side effects (4/6), and less pain during injection (4/6). One HCP preferred LEN (n=1) due to ease of injection preparation.

Key ISR data from the study:

  • Single doses of CAB LA were administered as one injection and single doses of LEN as two injections per product labeling, therefore 63 participants were administered a total of 124 LEN injections and 61 CAB injections during the study. Three participants received only one of the doses, all due to non drug-related reasons.
  • Following administration of both injectables, 4.4 times more ISR events were observed with LEN (n=538) than with CAB LA (n=123) and more participants experienced visible ISR events with LEN (n=221 LEN; n=36 CAB LA).
  • Pain was the most commonly reported ISR for LEN in 82% (n=51/62) of participants vs 80% (n=49/61) of participants receiving CAB LA (Relative Risk [RR] 0.98 [0.82, 1.16]).
  • There was a significantly higher risk of palpable and/or visible ISRs with LEN versus CAB:
    • Induration 87% (n=54) vs 18% (n=11) (RR 0.21 [0.12, 0.36])
    • Nodules 74% (n=46) vs 33% (n=20) (RR 0.44 [0.30, 0.65])
    • Erythema 57% (n=35) vs 12% (n=7) (RR 0.20 [0.10, 0.42])
    • Swelling 58% (n=35) vs 34% (n=21) (RR 0.59 [0.40, 0.89])
  • No serious adverse events or discontinuations due to drug-related adverse events were reported.

Since 2022, HIV diagnoses in Canada have increased by 35.2%, highlighting the growing need for improved HIV prevention strategies.1 As long-acting HIV prevention options continue to evolve, understanding patient experience and preference is critical to supporting uptake, adherence, and long-term prevention outcomes.

The CLARITY study findings, which will be presented at the 35th Canadian Conference on HIV/AIDS Research (CAHR 2026) taking place April 23rd – April 26th, 2026, underscore the importance of patient-centred care and innovation in long-acting injections as a tool to expand healthcare options for Canadians across the country.

About HIV

HIV (human immunodeficiency virus) is a virus that attacks the body's immune system.2 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.3

If HIV is not treated, it can lead to AIDS (acquired immunodeficiency virus). AIDS is the most severe stage of HIV (Stage 3). 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.4

As of 2022, approximately 65,270 people living with HIV in Canada, and 129 deaths attributed to HIV.5 In 2023, there were 2,434 new HIV diagnoses, a 35 per cent increase in new cases from the previous year.6

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 inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. 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.

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

* On 20 January 2026, GSK plc and Shionogi & Co., Ltd announced that they have reached agreement together with Pfizer Inc. for the economic interest in ViiV Healthcare Limited currently held by Pfizer to be replaced with an investment by Shionogi. Completion of the transaction is subject to certain regulatory clearances in relevant markets.

References:

  1. Government 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
  2. Health Canada. HIV and AIDS: Symptoms and treatment. Available at: https://www.canada.ca/en/public-health/services/diseases/hiv-aids.html.
  3. Health Canada. HIV and AIDS: Prevention and risks. Available at: https://www.canada.ca/en/public-health/services/diseases/hiv-aids/prevention-risks.html
  4. Health Canada, HIV and AIDS: For health professionals. Available at: https://www.canada.ca/en/public-health/services/diseases/hiv-aids/health-professionals.html.
  5. 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.
  6. 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.