HIV prevention drug approved in US but not yet in Canada

It’s not approved yet in Canada for prevention, but doctors are already prescribing it knowing it can make a “dramatic difference” in reducing HIV infection.

It’s called Truvada and studies have shown – as a prevention method known as PrEP, which stands for pre-exposure prophylaxis – if taken daily it can reduce the chance of HIV infection anywhere from 90 to 100 per cent.

“We know that if people are able to adhere with it pretty well, take their pill on most days, that it can achieve extremely high levels of protection, north of 95 per cent reduction in risk, one study even estimated something closer to 100 per cent reduction in risk,” Dr. Darrell Tan, an infectious disease physician, from St. Michael’s Hospital told Global News.

READ MORE: One in five HIV-positive Canadians don’t know they’re HIV-positive

Past studies have looked at those who take a daily pill and how that daily dose impacts prevention. A new Canadian study released today, looked at what happened in high risk populations that took the medication on an “on demand” basis. Participants took two pills hours or days before sex and two pills after, one at 24 hours and the next at 48. The study was published in the New England Journal of Medicine.

The results showed those who took Truvada “on demand” were 86 per cent less likely to get infected.

“The medication was taken as needed around periods of sexual activity. All study participants received regular HIV and STD prevention counselling and services, and stocks of condoms and lubricant,” said Dr. Cecile Tremblay of the University of Montreal.

Truvada is approved in the United States for prevention and treatment. It is approved in Canada for HIV treatment – not prevention.

“I think it could make a really dramatic difference and we have hard evidence that shows that is the case,“ said Tan.

The manufacturer of Truvada, Gilead Sciences Canada Inc, told Global News that it applied for Truvada to be used as a prevention method in August 2015.

Health Canada confirmed the application and said scientists at Health Canada are reviewing all scientific data, and “while it may not be possible to say precisely how long it will take to review Gilead’s submission, the Department’s target review time for this type of submission, where a new indication is being sought, is 300 days,” a spokeswoman said in an email to Global News.

READ MORE: Pills before and after sex can help prevent HIV, study finds

“We can reverse that by using this intervention and we have got to focus now on building the system and building the access to make it possible,” said Tan.

Dr. Tan, a clinician-scientist, is currently studying 50 men who are taking Truvada. In his research he is examining some of the concerns that have been raised, for example, will those who take Truvada be more likely to not practice safe sex with a condom and potentially expose themselves to sexually transmitted infections (STIs), and other risky behaviour.

Across the country, phyiscians are prescribing Truvada to patients for prevention in a practice called “off-label” prescribing said Dr. Rolando Barrios, director of epidemiology and population health at the BC Centre for Excellence in HIV/AIDS.

Right now if Canadians take Truvada for prevention, because it is not approved, they pay for it out-of-pocket, or by a private insurance plan. It can cost up to $1000 a month, if taken daily.