HIV groups call on PrEP maker Gilead to seek Health Canada nod
Petition asks Truvada manufacturer to apply here as it’s done in other countries
By Nathaniel Christopher on Tue, Apr 28, 2015
Gay men’s health and HIV prevention organizations are calling on the manufacturer of a drug that can significantly reduce the risk of HIV infection to file an application with Health Canada so that
HIV-negative people in Canada can more easily access Truvada.
Manufactured by Gilead Sciences, Truvada can be used as a pre-exposure prophylaxis (PrEP) taken daily
to prevent infection. Clinical trials show that taking the drug consistently can reduce HIV transmission
by more than 86 percent.
It was approved for use as PrEP in the United States in 2012.
“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,” reads an open letter authored by
Vancouver’s Health Initiative for Men (HIM).
“This leaves gay men and other vulnerable groups with limited access to a proven prevention tool,” the
letter states. “We find this policy inequitable and harmful to gay men’s health.”
The letter is endorsed by the AIDS Committee of Toronto, AIDS Vancouver, CATIE, YouthCO HIV & Hep C
Society, Vancouver Coastal Health Regional HIV Program, REZO in Montreal, and the Canadian Association
of Nurses in HIV/AIDS Care.
For Health Canada to consider approval for prescription medication, the drug manufacturer must submit
A spokesperson for Gilead says the company has had “no recent communications with Health Canada
regarding a PrEP filing.”
“We have submitted filings for Truvada for PrEP in Brazil, South Africa, Thailand and Australia, and
at the request of the French National Agency for Medicines and Health Products Safety (ANSM), Gilead
has provided data to permit an assessment of Truvada for a PrEP indication, which could result in
a recommendation for temporary use in France,” the spokesperson says.
Without approval from Health Canada, doctors here can only prescribe the pill “off-label” for those
who are willing and able to jump through “numerous technical hoops.”
“In order to obtain Truvada for PrEP, guys have to know what PrEP is, have a doctor who is willing
to prescribe it, the money to pay for it, or health insurance to cover it,” explains HIM program
manager Jody Jollimore. “We’re talking about a small fraction of guys.”
Without insurance the treatment can cost approximately $900 per month.
Jollimore notes that gay men and other men who have sex with men are the most at-risk population when
it comes to HIV and have always been at the forefront of HIV prevention. “We use condoms, test and treat
at higher rates than any other population,” he says.
“There is a new tool that gay men want,” he continues. “They are excited about it. They call our
offices, ask our team, create Facebook groups — and those lucky enough to have a doctor to
prescribe it, display it proudly on their sexual networking profiles.”
Jollimore says prevention agencies, health ministries and drug companies should be doing everything
in their power to remove barriers between gay men and HIV preventions tools such as Truvada.
“I’ve been in rooms where questions have been asked about what the plans are for rolling out PrEP
in Canada, and Gilead reps were in the room,” he says. “They know gay men in Canada are accessing
Truvada off-label, even though they may not have had a letter presented to them saying so. We
wanted to ask them in a very direct way to make application for this as they’ve done in other countries.”
Gilead Canada general manager Ed Gudaitis did not respond to Daily Xtra’s requests for comment
by posting time.
Read the full letter to Gilead below
Ed Gudaitis, General Manager
Gilead Sciences Canada
6711 Mississauga Road, Suite 600
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 that 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 accounted 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
AIDS Committee of Toronto
REZO in Montreal
YouthCO HIV & Hep C Society
Vancouver Coastal Health Regional HIV Program
Canadian Association of Nurses in HIV/AIDS Care (CANAC)
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