HEALTH CANADA GRANTS PRIORITY REVIEW STATUS OF ViiV HEALTHCARE’S NEW DRUG SUBMISSION FOR CABOTEGRAVIR LONG-ACTING INJECTABLE AND TABLETS FOR PREVENTION OF HIV

  • Upon approval, cabotegravir would be the first injectable, long-acting therapy in Canada for HIV prevention.
  • Application is supported by data from the pivotal phase IIb/III studies evaluating safety and efficacy of long-acting cabotegravir for pre-exposure prophylaxis (PrEP) in men who have sex with men, transgender women, and cisgender women at increased risk of HIV acquisition.
  • When given as few as six times per year, cabotegravir for PrEP demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF) tablets in reducing the risk of HIV acquisition.
  • The latest Canadian surveillance data shows that there were 1,833 new HIV diagnoses in 2022, a 24.9 per cent increase from 2021.1

MONTRÉAL, QC, Jan. 10, 2024/CNW/ - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, has filed a New Drug Submission (NDS) to Health Canada for investigational, cabotegravir long-acting (LA) injectable and tablets for PrEP. The submission is being reviewed under the Priority Review Policy.

If approved, cabotegravir would be the first long-acting therapy available in Canada for PrEP to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV.

Health Canada grants Priority Review status to drug submissions intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating illnesses or conditions for which there is substantial evidence of clinical effectiveness that the drug addresses an unmet medical need or provides a benefit/risk profile that is improved over existing therapies.

"As a global leader in HIV treatment, research and innovation, we are excited for the potential that long-acting cabotegravir for PrEP has to enhance options for Canadians to prevent sexually acquired HIV,” says Jean-Francois Fortin, Country Medical Director, Canada, at ViiV Healthcare. “We are thrilled that Health Canada has granted Priority Review and has determined the potential benefits of offering a variety of options for HIV prevention. We believe that ViiV Healthcare is one step closer to providing Canadians with a long-acting option to protect themselves against HIV, reaffirming our commitment to end the HIV epidemic.”

Canada’s regulatory submission follows approvals for use in the U.S., Australia, Brazil, South Africa, the European Union, as well as a number of other countries. Submission to other regulatory agencies is ongoing.

The NDS includes data from two pivotal phase IIb/III studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in men who have sex with men, transgender women, and cisgender women who were at increased risk of HIV.2,3 The studies demonstrated that cabotegravir long-acting for PrEP was superior to daily oral emtricitabine/tenofovir disproxil fumarate (FTC/TDF), with clinical trial participants experiencing 69 per cent lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 083, and a 90 per cent lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084.4,5

About HPTN 083 (NTC02720094)6

The HPTN 083 trial is a phase IIb/III double blind non-inferiority trial designed to evaluate the safety and efficacy of long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTV/TDF tablets (200 mg/300 mg). The trial included the prespecified ability to test for superiority of long-acting cabotegravir over FTC/TDF. The trial design included an oral lead-in phase to assess tolerability to cabotegravir before administering the intramuscular injection. HPTN 083 was conducted in 4,566 men who have sex with men and transgender women who have sex with men. The study opened to enrollment in November 2016 at research centres in Argentina, Brazil, Peru, United States, South Africa and Vietnam.

Long-acting cabotegravir was found to be superior to daily oral FTC/TDF in preventing HIV acquisition in the study population. The most common adverse reactions (all grades) observed in at least 1 per cent of subjects receiving long-acting cabotegravir were injection sites reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, and abdominal pain.

For further information on HPTN 083 please see https://clinicaltrials.gov/ct2/show/NCT02720094.

About HPTN 084 (NTC03164564)

The HPTN 084 trial is a phase III double blind superiority trial designed to evaluate the safety and efficacy of the long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg) in 3,224 cisgender women who are at increased risk of HIV acquisition. The trial design included an oral lead-in phase to assess tolerability to cabotegravir before administering the intramuscular injection. HPTN 084 opened to enrolment in November 2017 research centres in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda, and Zimbabwe.

Long-acting cabotegravir was found to be superior to daily oral FTC/TDF in preventing HIV acquisition in the study population. The most common adverse reactions (all grades) observed in at least 1% of subjects receiving long-acting cabotegravir were injection site reactions, diarrhea, headache, fatigue, sleep disorders, nausea, dizziness, abdominal pain, vomiting, myalgia, and rash. For further information please see https://clinicaltrials.gov/ct2/show/NCT03164564.

About HIV

HIV (human immunodeficiency virus) is a virus that attacks the body’s immune system.7  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.8

If HIV is not treated, it can lead to AIDS (acquired immunodeficiency virus). AIDS is the most severe stage of HIV (Stage 3).9  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.

At the end of 2022, 39 million people lived with HIV around the world, with 1.3 million new diagnoses that year and 630,000 deaths from AIDS-related illnesses.10 The latest Canadian surveillance data shows that there were 1,833 new HIV diagnoses in 2022, a 24.9 per cent increase from 2021.11

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 can benefit from HIV prevention options. 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.com/en-ca/.

References:
  1. PHAC. HIV in Canada: 2022 Surveillance Highlights. Available at: https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/diseases-conditions/hiv-2022-surveillance-highlights/hiv-2022-surveillance-highlights.pdf. Accessed December 8, 2023.
  2. Marzinke M, Grinsztejn B, Fogel J, Piwowar-Manning EM et al, Laboratory Analysis of HIV Infections in HPTN 083: Injectable CAB for PrEP. Conference on Retroviruses and Opportunistic Infections Abstract 153
  3. Delany-Moretlwe S, Hughes JP et al. Long acting injectable cabotegravir is safe and effective in preventing HIV infection in cisgender women. HIV Research for Prevention Virtual Conference (HIVR4P 2021) abstract HY01.02, 2021.
  4. Clinical Trials.gov - Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men. Available at https://clinicaltrials.gov/ct2/show/NCT02720094. Accessed December 8, 2023.
  5. Clinical Trials.gov - Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women. Available at https://clinicaltrials.gov/ct2/show/NCT03164564. Accessed October 2022.
  6. CDC statement on FDA approval of drug for HIV prevention. News release CDC NCHHSTP Newsroom. July 16, 2012. Accessed September 7, 2021. https://www.hiv.gov/blog/fda-approves-first-drug-for-reducing-the-risk-of-sexually-acquired-hiv-infection
  7. CDC. About HIV. Available at: https://www.cdc.gov/hiv/about/index.html.
  8. 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/. Accessed November 9, 2023
  9. CDC. About HIV. Available at: https://www.cdc.gov/hiv/basics/whatishiv.html#:~:text=People%20who%20take%20HIV%20treatment,into%20Stage%203%20(AIDS). Accessed November 9, 2023
  10. UNAIDS. Global HIV & AIDS Statistics – Fact sheet. Available at: https://www.unaids.org/en/resources/fact-sheet.
  11. PHAC. HIV in Canada: 2022 Surveillance Highlights.