Health Canada Approves ViiV's APRETUDE for HIV PrEP

Health Canada has granted approval for APRETUDE (cabotegravir tablets and extended-release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV infection in at-risk individuals who are HIV-1 negative. This approval marks a significant milestone in HIV prevention, providing a new option for at-risk adults and adolescents aged 12 years and older, weighing at least 35 kg, including men who have sex with men, transgender women, and cisgender women.

APRETUDE is the first long-acting injectable PrEP treatment approved in Canada. This innovative treatment reduces the frequency of doses required for effective HIV prevention from daily pills to as few as six injections per year. In clinical trials, cabotegravir injectable suspension demonstrated superior efficacy compared to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF tablets), making it a promising alternative for those seeking effective HIV prevention methods.

Jean-Francois Fortin, Country Medical Director at ViiV Healthcare in Canada, expressed pride in offering APRETUDE as a new prevention option. He emphasized the importance of providing Canadians with effective preventive measures to combat HIV, aligning with the collective goal of ending the HIV epidemic. Fortin also highlighted the company's commitment to collaborating with provincial, territorial, and national health authorities to ensure the availability of APRETUDE across Canada.

HIV remains a significant public health concern in Canada, with recent statistics showing a 24.9% increase in new HIV diagnoses in 2022 compared to the previous year. PrEP has been identified as a crucial tool in reducing new HIV cases and combating the epidemic. Despite the availability of daily oral PrEP, inconsistent adherence and various barriers have led to underutilization among key populations.

The Health Canada approval is based on two pivotal phase IIb/III studies, HPTN 083 and HPTN 084. These studies evaluated the safety and efficacy of cabotegravir long-acting injections for PrEP in men who have sex with men, transgender women, and cisgender women at increased risk of HIV. The studies demonstrated that cabotegravir long-acting injectables were superior to daily oral FTC/TDF, with participants experiencing significantly lower rates of HIV acquisition.

The HPTN 083 trial included 4,566 men who have sex with men and transgender women across various countries, while the HPTN 084 trial involved 3,224 cisgender women in African countries. Both trials included an oral lead-in phase to assess tolerability to cabotegravir before administering the intramuscular injection. The most common adverse reactions observed in these trials were injection site reactions, diarrhea, headache, fatigue, sleep disorders, nausea, dizziness, and abdominal pain.

Cabotegravir extended-release injectable suspension works as an integrase strand transfer inhibitor (INSTI), preventing HIV replication by inhibiting the integration of viral DNA into human immune cells. This step is crucial in the HIV replication cycle and establishing chronic disease. Cabotegravir tablets can be used as an oral lead-in to assess tolerability or as short-term PrEP for those who might miss planned dosing.

The approval of APRETUDE represents a significant advancement in HIV prevention in Canada. By offering a long-acting injectable option, it addresses the challenges of adherence associated with daily oral PrEP. This new option is expected to play a vital role in reducing HIV transmission and supporting the country's efforts to end the HIV epidemic.