Policy & Regulation
Gilead Canada Announces Notice of Compliance for Descovy for HIV Pre-Exposure Prophylaxis
4 December 2020 - - Health Canada has granted a Notice of Compliance for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for Pre-Exposure Prophylaxis to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk of HIV acquisition, US-based biopharmaceutical company Gilead's (NASDAQ: GILD) Gilead Sciences Canada, Inc. business said.

Canada is now the third market globally to receive approval of Descovy for the PrEP indication following the approval by the US Food and Drug Administration in October, 2019, and the Taiwan Food and Drug Administration in August, 2020.

Descovy is indicated for PrEP to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing ≥ 35 kg, excluding individuals at risk from receptive vaginal sex.

Descovy is taken orally once daily with or without food. Descovy is also approved in Canada for the treatment of HIV-1 infection in adults and pediatric patients weighing ≥ 25 kg, in combination with other antiretroviral agents.

PrEP is an HIV prevention strategy to reduce the risk of acquiring HIV infection. It can be taken by HIV-negative individuals considered at high risk of infection.

PrEP is taken daily, on an ongoing basis, in advance of high-risk activity.

According to the Public Health Agency of Canada, when medication for PrEP is taken as prescribed, the medication reduces the risk of acquiring sexually transmitted HIV by more than 90 per cent.

Before prescribing Descovy for PrEP, healthcare providers must counsel all uninfected individuals to strictly adhere to the recommended Descovy dosing schedule and must screen all individuals for HIV-1 immediately prior to initiating Descovy for PrEP and at least once every three months while taking Descovy, and upon diagnosis of any other sexually transmitted infections.

The PrEP indication is based on data from the Descovy trial, a multi-year global Phase 3 registrational clinical trial that evaluated the safety and efficacy of Descovy for PrEP compared with that of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP in reducing the risk of acquiring HIV-1 infection.

Enrollment included more than 5,300 adult cisgender men who have sex with men or transgender women who have sex with men.

Gilead Sciences is a US-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.

Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc. and was established in Mississauga, Ontario, in 2006.