Gilead: Please ask Health Canada to approve Truvada for PrEP

We are calling on Gilead Sciences to make immediate application to Health Canada for use of Truvada in HIV pre-exposure prophylaxis (PrEP). If you agree, please sign our Open Letter to Gilead Sciences.

Ed Gudaitis, General Manager
Gilead Sciences Canada
6711 Mississauga Road, Suite 600
Mississauga, ON
L5N 2W3 

April 28th, 2015

Dear Mr. Gudaitis:

On behalf of HIV prevention agencies, gay men’s health organizations and gay men in Canada, we are calling on Gilead Sciences to make immediate application to Health Canada for use of Truvada in HIV pre-exposure prophylaxis.

In December 2010 the New England Journal of Medicine published findings from the Gilead sponsored iPrEx trial examining the effectiveness of HIV pre-exposure prophylaxis (PrEP) in gay men and other men who have sex with men. The study ultimately showed that HIV was successfully prevented in over 90% of cases in men who were adherent to a daily dose of Truvada. Similar results were demonstrated in the subsequent PROUD trial from the UK and IPERGAY in France and Canada. 

The advent of PrEP and its subsequent uptake by HIV-negative gay men, particularly in the United States, has been a welcome addition to the HIV prevention toolkit. Traditional interventions such as education, condoms, and treatment as prevention have been highly successful but they have failed to completely stem the tide of new infections. In 2011, the Public Health Agency of Canada estimated the HIV incidence rate for men who have sex with men was 71 times higher than other men. In 2013 approximately 1000 Canadian gay men were diagnosed with HIV. These account for 50% of new infections in the country. Most become infected by partners who themselves are newly infected and/or unaware of their sero-positive status. PrEP offers additional protection to HIV-negative men who may find themselves in these situations.

In July 2012 the FDA approved the use of Truvada for PrEP in the United States and the US Centre for Disease Control developed clinical practice guidelines for administration of PrEP in vulnerable populations. Yet access to Truvada for PrEP in Canada remains elusive. Currently, it is prescribed “off-label” and treatment is administered under a patchwork of monitoring with little or no regulation. We applaud Gilead’s support for PrEP in the United States and its recent announcement to seek approval in Australia but without formal approval in Canada it is not possible to establish publicly funded and regulated programs, or to evaluate cost effectiveness and safety. This leaves gay men and other vulnerable groups with limited access to a proven prevention tool. We find this policy inequitable and harmful to gay men’s health.

At Health Initiative for Men, we consider PrEP to be a safe and effective HIV prevention tool when it is prescribed and administered in a regulated environment. We believe that barriers to access should be minimized for gay men and other vulnerable populations. A formally approved indication for the use of Truvada in HIV pre-exposure prophylaxis is the first step to achieving this goal. We further intend to actively petition public health officials at all levels for comprehensive PrEP guidelines and for approval of publicly funded programs. If we are to be serious about stopping HIV in all populations, and particularly in gay men, we must make PrEP more easily accessible. To quote from Chris Beyrer at the Center for Public Health and Human Rights in a recent Lancet publication, ‘Pre-exposure prophylaxis works – it’s time to deliver’.

Board of Directors,
Health Initiative for Men

Signatories:

AIDS Committee of Toronto (ACT)
AIDS Vancouver
Canadian Association of Nurses in HIV/AIDS Care (CANAC)
CATIE
REZO: Santé et mieux-être des hommes gais et bisexuels
Vancouver Coastal Health Regional HIV Program
YouthCO HIV & Hep C Society

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